“A STUDY ON THE ASSESSMENT OF QUALITY OF LIFE IN VITILIGO PATIENTS ATTENDING VITILIGO CLINIC IN DERMATOLOGY

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“A STUDY ON THE ASSESSMENT OF QUALITY OF LIFE IN VITILIGO PATIENTS ATTENDING VITILIGO CLINIC IN DERMATOLOGY

OUTPATIENT DEPARTMENT”

Dissertation Submitted in

Partial fulfilment of the University regulations for

MD DEGREE IN

DERMATOLOGY, VENEREOLOGY AND LEPROSY (BRANCH XX)

MADRAS MEDICAL COLLEGE

THE TAMIL NADU DR. M.G.R. MEDICAL UNIVERSITY CHENNAI

APRIL 2017

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CERTIFICATE

Certified that this dissertation titled “A STUDY ON THE ASSESSMENT OF QUALITY OF LIFE IN VITILIGO PATIENTS ATTENDING VITILIGO CLINIC IN DERMATOLOGY OUTPATIENT DEPARTMENT” is a bonafide work done by Dr.P.BALAMURUGAN Postgraduate student of the Department of Dermatology, Venereology and Leprosy, Madras Medical College, Chennai – 3 during the academic year 2014 – 2017. This work has not previously formed the basis for award of any degree.

Prof .Dr. U.R.DHANALAKSHMI, MD., D.D., D.N.B.,

Professor and Head,

Department of Dermatology, Madras Medical College &

Rajiv Gandhi Govt. General Hospital, Chennai-3.

Prof .Dr. K. MURALITHARAN, M.S., M.C.H.,

Dean

Madras Medical College Chennai-3.

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DECLARATION

The dissertation entitled “A STUDY ON THE ASSESSMENT OF QUALITY OF LIFE IN VITILIGO PATIENTS ATTENDING VITILIGO CLINIC IN DERMATOLOGY OUTPATIENT DEPARTMENT” is a bonafide work done by Dr.P.BALAMURUGAN at Department of Dermatology, Venereology and Leprosy, Madras Medical College, Chennai – 3, during the academic year 2014 – 2017 under the guidance and supervision of : Prof. DR.

V.SAMPATH MD.D.V, D.D Professor, Department of Dermatology, Madras Medical College/RGGGH, Chennai –3.

This dissertation is submitted to The Tamil Nadu Dr. M.G.R.

Medical University, Chennai towards partial fulfillment of the rules and regulations for the award of M.D Degree in Dermatology, Venereology and Leprosy (BRANCH – XX)

Prof. DR. V.SAMPATH MD.D.V, D.D Professor,

Department of Dermatology,

Madras Medical College/RGGGH,

Chennai – 3.

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DECLARATION

I, Dr.P.BALAMURUGAN solemnly declare that the dissertation on

“A STUDY ON THE ASSESSMENT OF QUALITY OF LIFE IN VITILIGO PATIENTS ATTENDING VITILIGO CLINIC IN DERMATOLOGY OUTPATIENT DEPARTMENT” was done by me at Madras Medical College during 2014-2017 under the guidance and supervision of Prof. DR. V.SAMPATH MD, Professor, Department of Dermatology, Madras Medical College/RGGGH, Chennai –3

The dissertation is submitted to the Tamil Nadu DR.MGR Medical University towards the partial fulfilment of the rules and regulations for the award of M.D Degree in Dermatology, Venereology and Leprosy (BRANCH – XX).

PLACE: CHENNAI DR .P.BALAMURUGAN

DATE:

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SPECIAL ACKNOWLEDGEMENT

My sincere thanks to Dr. K. MURALITHARAN M.S., M.C.H., Dean, Madras Medical College, Chennai-3 for allowing me to do this dissertation and utilize the Institutional facilities.

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ACKNOWLEDGEMENT

I am grateful to the Professor and Head of the Department of Dermatology, Prof. Dr. U.R. DHANALAKSHMI, M.D., D.D., D.N.B., for her advice, guidance and encouragement for my study.

I would like to express my sincere and heartfelt gratitude to

Prof. Dr. S. KALAIVANI, M.D., D.V., Director and Professor, Institute of Venereology, for her kindness and support throughout the study.

I sincerely thank my guide Prof. Dr. V.SAMPATH M.D., Professor for his valuable support. He has been a source of constant motivation and encouragement throughout the study. I am extremely grateful to him for guiding me throughout the study.

I sincerely thank Prof. Dr. R. PRIYAVATHANI ANNIE MALATHY, M.D., D.D., D.N.B., M.N.A.M.S., Professor of dermatology for her help and support.

I thank Prof. Dr. S. KUMARAVEL, M.D., D.D., Professor of Dermatology for his advice and encouragement.

I thank Prof. Dr. S. NIRMALA M.D., Professor and Head of Department, Department of Occupational and Contact Dermatitis for her advice and encouragement.

I thank Prof. Dr. A. RAMESH M.D., D.D., D.N.B., Professor of Dermatology for his advice and encouragement.

I am grateful to Prof. Dr. J. MANJULA, M.D., D.N.B., Professor,

Department of Dermatology for her invaluable guidance, help and encouragement.

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I humbly thank my Co-Guide Dr.B.VIJAYALAKHSMI,M.D.D.V.L., Assistant professor, Department of Dermatology for her valuable guidance throughout my work. I would like to express my sincere and heartfelt gratitude for the time which she devoted for my research project.

I extend my gratitude to Dr.R.MADHU, M.D.,(DERM).,D.C.H., Dr.SAMUEL JEYARAJ DANIEL, M.D.D.V.L., Dr. K.DEEPA, M.D.D.V.L, Dr.V.N.S.AHAMED SHARIFF, M.D.D.V.L., Dr.K.UMAMAHESWARI, M.D.D.V.L., Dr.R.MANIPRIYA,M.D.D.V.L.,D.C.H., and Dr.C.L.CHITRA,M.D.DV.L Assistant professors, Department of Dermatology for their kind support and encouragement.

I also thank my Assistant Professors Dr. P. PRABHAKAR, M.D.D.V.L., Dr. C. VIDHYA, M.D.DVL., Dr.R.HEMAMALINI, M.D.D.V.L.,

Dr.H.DHANASELVI, M.D.D.V.L., Dr.K.GAYATHRI, M.D.D.V.L., Dr.E.BALASUBRAMANIAN, M.D.D.V.L and Dr.R.SNEKAVALLI M.D.D.V.L., Institute of Venereology for their able guidance.

I am thankful to my colleagues for their support throughout the study. I am

also grateful to all paramedical staffs for rendering timely help to complete my

study. Last but not the least I am profoundly grateful to all patients for their co-

operation and participation in this study. They have been the principal source of

knowledge which I have gained during the course of my clinical research.

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CONTENTS

SERIAL NO. CHAPTERS PAGE NO.

1 INTRODUCTION 12-14

2 REVIEW OF LITERATURE 15-38

3 AIM AND OBJECTIVES 39-40

4 MATERIALS AND METHODS 41-51

5 RESULTS 52-91

6 DISCUSSION 92-99

7 CONCLUSION 100-103

8 BIBLIOGRAPHY 104-111

9 ANNEXURES

10 ANNEXURE I: ABBREVIATIONS ANNEXURE II: MASTER CHART ANNEXURE III: KEY FOR MASTER CHART

ANNEXURE IV: PROFORMA ANNEXURE V: INFORMATION SHEET

ANNEXURE VI: CONSENT FORM ANNEXURE VII: ETHICAL APPROVAL

CERTIFICATE

112-113 114-118 119-121 122-126 127-130 131-134

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INTRODUCTION

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INTRODUCTION

Vitiligo is a disorder which causes the loss of color of the skin in blotches. The Rate of loss of color and the extent of the loss of skin color is usually unpredictable in Vitiligo. It affects the skin on all the parts of our body. It can affect the hair, the eyes and also other areas such as the inside of the mouth. Vitiligo is a depigmentation disorder capable of affecting patients of all age groups and both the sexes.

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Generally, the color of our hair, skin and eyes in our body is mainly determined by melanin. This condition happens when the cells that yield melanin die, cease or discontinue functioning. Vitiligo as a disorder affects individuals of all skin types, on the other hand it may be more conspicuous in subjects with darker skin, but this condition is never life-threatening or serious or transmissible. On the other hand, Vitiligo can be stressful and it may make give a sense of inferiority about self.

In a Depigmentation disorder like Vitiligo, the main concern of the patients is the cosmetic defect caused by the disease. The disease commonly involves the exposed parts like face and extremities. Even though the disease do not cause functional disability the psychological effects makes the patients to lead a compromised quality of life.

In a nation like India where most of the people are dark skinned this depigmentation disorder causes a major attraction. The Vitiligo patients are embraced by the starring look thrown at them in the public places. These patients even loose

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employment opportunities because of the cosmetic disfigurement caused by the disease.

The female patients suffer the major impact of the disease .Young females face the problem of either not getting married or in the course of their marital life.

Pediatric Vitiligo patients are psychologically affected due to the teasing behavior of their classmates. Most of them discontinue their studies. These children are more prone for involving in antisocial activities and other abuses. The parents of these patients suffer both economically and psychologically.

The disease being of chronic nature, with treatment of long term nature , absence of an ideal effective therapy and erratic course of disease which is almost unpredictable is typically very much depressing and disheartening for the patients with Vitiligo. So, in order to measure and associate the psychological morbidity of Vitiligo, this study was carried out.

While the trends in Quality of Life of Vitiligo patients were already well documented through many studies among various Indian populations, only a limited research were known to have present about the Vitiligo patients in populations of Tamilnadu. Moreover there is also no research have ever been conducted till now in the purview of the Vitiligo patients in Chennai. So the present study is the first of its kind, conducted to assess the Quality of life among Vitiligo patients attending Vitiligo clinic in Dermatology Outpatient Department in a Medical College Hospital, Chennai, Tamil Nadu.

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REVIEW OF LITERATURE

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REVIEW OF LITERATURE

DEFINITION AND EPIDEMIOLOGY:

Vitiligo is a disorder, which is usually acquired, and associated with changes in the skin which is usually pigmentary, and also affects the mucous membranes and is generally described as circumscribed lesions with macules and patches that are depigmented .

Skin being the largest organ of the body, with a total area of about 20 square feet, has 3 layers - Epidermis, Dermis and Hypodermis. Being a sensory organ, it is responsive to stimuli that are emotional and its appearance in turn greatly influences our body image and our self-confidence. Vitiligo as a disorder has several problems which are psychological and social. One common opinion is that several cases of dermatological disorder are produced by psychological pressure, or are associated to definite personality traits or symbolize a problem of a psychiatric disorder.

Vitiligo is an idiopathic skin disease, which is usually acquired and is due to lack of melanin production by certain special type of cells called melanocytes, which are located in the epidermis. Vitiligo is described as progressive loss of the skin color which ultimately leads to white coloured patches and in some cases total depigmentation¹.

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It affects about one to four percentage of the world population^2,3.

Vitiligo has a special implication to patients in our country because in our country, depigmentation appears clearly or conspicuously on darker skin and is also due to the massive stigma that accompanies the disease ⁴.

PATHOPHYSIOLOGY OF VITILIGO:

As a disorder which is multifactorial and which is polygenic, Vitiligo has a compound pathogenesis. Both genetic and non-genetic factors play a role in the pathogenesis of Vitiligo. Even though several number of theories have been projected about it, the exact cause remains mysterious.

The Criteria that are generally agreed upon are nonexistence of the melanocytes which are functional in skin and a loss of histochemically acknowledged melanocytes, because of their demolition. Though, the destruction is presumably a slow process and takes a long course, which results in a progressive reduction of number of the melanocytes. Numerous theories exist concerning the destruction of melanocytes and these theories can be summarized as follows

1. Autoimmune mechanisms⁵, 2. Intrinsic defect of melanocytes, 3. Cytotoxic mechanisms,

4. Oxidant-antioxidant mechanisms, and 5. Neural mechanisms.

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I. AUTOIMMUNE DESTRUCTION OF MELANOCYTES

This theory suggests that there are changes in humoral and cellular immunity, which usually occur in the case of destruction of melanocytes as it happens in Vitiligo.

Most of the autoimmune disorders such as ― Thyroid disorders, especially Hashimoto thyroiditis and the Grave‘s disease; Endocrine system disorders like the Addison disease and Diabetes mellitus; and dermatological disorders like alopecia areata; psoriasis; and other disorders like inflammatory bowel disease; autoimmune polyglandular syndrome are all associated with vitiligo‖.

The most conclusive evidence supporting this hypothesis is the occurrence of circulating antibodies ⁶. This hypothesis of humoral immunity is supplemented by the evidence that the melanocytes are demolished in healthy skin which raft is grafted onto the mice which were inoculated with sera from the subjects suffering from vitiligo.⁷

There is also a strong evidence for the hypothesis which indicates the contribution and association of cellular immunity in vitiligo.

The Devastation of melanocytes in vitiligo may be facilitated by the CD8+ T cells that are autoreactive. Activated CD8+ T cells have been demonstrated in perilesional vitiligo skin. In subjects suffering from Autoimmune vitiligo, Melanocyte- specific T cells have been spotted in the peripheral blood ^8,9.

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II. INTRINSIC DEFECT OF MELANOCYTES

The melanocytes in Vitiligo appear to have an intrinsic defect which results in their death, leading to depletion of melanocytes. They exhibit various defects and deformities, including irregular, rough endoplasmic reticulum as a result of which, they are incompetent and there is defective synthesis and processing.

Dysregulation of Homing-receptor, in supplementation to these defects have also been noticed. Premature apoptosis of melanocytes is also a contributing factor.

However, in many other studies done subsequently, the Vitiligo melanocytes had comparable susceptibility with that of cells that were producing melanin normally¹⁰.

III. DISTURBANCE IN OXIDANT-ANTIOXIDANT SYSTEM IN VITILIGO

Oxidative stress also has a huge role to play in the pathophysiology of vitiligo. Numerous Studies propose that buildup and gathering of free radicals, which are lethal to melanocytes, causes their demolition.

In some studies subjects with vitiligo exhibited a typical yellow/green or bluish fluorescence in their skin, and ultimately with further evidence, this led to the hypothesis that this buildup of 2 unlike oxidized pteridines was responsible for the color change that happens in vitiligo. This excessive production, and hence forth resulting

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accumulation of the pteridines, is due to a defect in tetrahydrobiopterin homeostasis, which is essentially metabolic in nature. Melanocytotoxic hydrogen peroxide accumulates resulting in the destruction of the cells.

Oxidative stress was thought to be the triggering pathogenic event in melanocyte deterioration. Numerous studies conducted support this theory. By measuring levels of the two enzymes, which are antioxidant in nature i.e., superoxide dismutase (SOD) and the other enzyme, catalase (CAT) in the skin of the patients with lesions of vitiligo and in normal healthy subjects, this theory was put forward.

When the level of SOD is high and the level of CAT is low, it gives a clue to this hypothesis of alterations in the Oxidant and the Anti-oxidant systems in subjects with Vitiligo¹¹.

IV. NEURAL THEORY

In many Case reports, there is evidence of subjects suffering with a nerve injury and also have vitiligo, i.e., lesions that are either hypo pigmented or depigmented in areas that are enervated.

Moreover, segmental vitiligo habitually occurs in a dermatomal pattern thereby suggesting that there is a definite involvement of chemical mediators , which are responsible for defective melanin production and are produced from nerve endings.

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In depigmented patches, there is a surge in adrenergic activity, resulting in sweating and vasoconstriction. In conclusion, amplified urinary elimination of two neurometabolites has been noted. They are Homovanillic acid and Vanilmandelic acid.

But, whether this is a primary or secondary phenomenon remains elusive.

In Conclusion though the ultimate cause is not completely understood , this disorder does not mirror simple loss of melanocytes , but also explains various possible alterations in immune system and also other defects in the molecular level causing metabolic changes and accumulation of metabolites, causing destruction of pigment producing cells ;

But various theories also suggest that in depigmented lesions of the so called vitiligo, melanocytes may be present even after years of the disease and may respond to the treatment of the disease.

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GENETICS OF VITILIGO

Vitiligo as a condition is branded with 1) Incomplete penetrance,

2) Heterogeneity,

3) Multiple loci that are susceptible ¹².

The genes connected with the melanin Synthesis, and oxidative stress, and those regulating autoimmunity¹³ are responsible for inheritance of vitiligo.

Human leukocyte antigens (HLAs) are said to be linked with inheritance of vitiligo , but this association is not always constant. HLA-DR4 is augmented in blacks, while HLA-B35 is inflated in Yemenite Jews. In subjects with Anti thyroid antibodies, a connotation with HLA-B13 has been defined. Significant association with single- nucleotide polymorphisms in autoimmune diseases and vitiligo have been noted¹⁴.

The age at which the vitiligo has its onset also has an involvement of a genetic component; Many Genome wide association studies have shown that the locus for age of onset of this condition was situated in the major histocompatibility complex class (MHC) II region which was adjacent to a region which has been related with generalized susceptibility to vitiligo ¹⁵.

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Many studies have reported a female preponderance for vitiligo, but this can be due to increased reporting by female subjects of their lesions with cosmetic concerns. This disorder may possibly appear at any time i.e. at any age from birth to old age even in the skin that has attained senescence. The onset of this disorder is observed mostly in persons who are aged between 10-30 years. Vitiligo rarely occurs in infants or in old people. Almost all circumstances where vitiligo occurs are developed relatively early. The typical age of onset is about 20 years. The age of onset is improbable to differ between the genders. Intensified concern about the look of the skin could give an early alertness amidst females. ^1,2,3,4

CLASSIFICATION AND CLINICAL FEATURES:

Vitiligo expresses itself as an acquired white macule or patch or macules that are hypo pigmented. Theses lesions are generally well delineated, circumscribed and lesions may be round, oval, or linear in shape. Their boundaries may be convex.¹⁶

These Lesions usually expand centrifugally with time at an irregular rate.

The size of these lesions may vary from some millimeters to many centimeters.

Primary lesions arise most habitually on the hands and also can also arise on the forearms, their feet, and their face, which usually favours a distribution around the eyes and the mouth .

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These lesions could be localized to a particular area or may be generalized. Generalized lesions are more common than the localized vitiligo, while the latter is usually restricted to one broad area along with a segmental or quasidermatomal pattern.

Generalized vitiligo, on the other hand suggests that there are involvement of further than one general zone . In this generalized pattern, the macules are typically found on either sides of the trunk, which is either symmetrically distributed or asymmetrically displayed.

The most typical sites of occurrence of vitiligo are the face, neck, and scalp.

These places of manifestation are areas which are endangered to repetitive trauma, such as:

1. The Bony prominences

2. The Extensor aspects of the forearm 3. The Ventral part of wrists

4. The Dorsum of hands and 5. The Digital phalanges

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When the mucous membrane is involved, it occurs mostly in the background of generalized vitiligo. This disorder habitually happens around the body cavities such as the lips, gingiva, the genitals, the areola and nipples.

Body hair, also known as leukotrichia, which occurs in vitiliginous lesions, would be depigmented. The Vitiligo of the scalp typically give the impression as a restricted patch of hair which is white or gray, but sometimes the complete depigmentation of all hair in the scalp may occur. Scalp association is the most common, shadowed by association of the eyebrows, the hair in the pubis, and the axillary hair, correspondingly.

Leukotrichia may possibly specify a poor prognosis in respect to repigmentation. Natural repigmentation of depigmented hair seems not to occur in vitiligo subjects.

CLINICAL VARIANTS

Trichrome vitiligo has a transitional zone of hypochromic which is situated between the achromic center and the outlying unaffected skin. The usual development of the hypopigmented areas is evolution to full depigmentation. This will result in three shades of coloured known as brown, tan, and white in the same subject.

Marginal inflammatory vitiligo appears as a lesion with red, raised border. It may

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exhibit itself from the onset of vitiligo or it may appear some months or years subsequently after the primary onset. Pruritus, which is usually mild, may be present.

Quadrichrome vitiligo, another variation of vitiligo, at sites of perifollicular repigmentation, reflects the existence of a fourth colour that is dark brown . A circumstance with 5 shades of color known as pentachrome vitiligo has also been defined.¹⁷

Blue vitiligo effects in blue colouration of macules. This kind of pigmentation has been detected in a subject with post inflammatory hyperpigmentation , and they subsequently turn out to develop vitiligo.

The occurrence of vitiligo in places of specific trauma or injury, such as those after a cut or abrasion is described as Koebner phenomenon. For Koebner phenomenon to take place, minimum injury is required.

CLINICAL CLASSIFICATIONS OF VITILIGO

The criteria by which vitiligo is classified is of importance because each type of vitiligo is associated with specific characteristics. The most commonly used classification is based on how the lesions are distributed.

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They are classified as

1) Localized, 2) Generalized, and 3) Universal types

1. Localized vitiligo types are described below:

 Focal: This type is defined by presence of one or more macules in any one area or region of the body and is, most frequently seen in the distribution of the trigeminal nerve.

 Segmental: This type is characterised by presence of one or more macules which occur in a specific dermatomal pattern or quasidermatomal pattern. It occurs frequently in children. More than fifty percentages of the patients with this type of vitiligo have patches of distribution of white hair or poliosis. Segmental vitiligo is not usually related with thyroid disorders or any other disorders of autoimmune origin.

 Mucosal: In this type, only the Mucous membranes are involved.

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2. Generalized vitiligo types are described as follows::

 Acrofacial: Here Depigmentation typically occurs on the distal fingers and on the areas around the orifices – Periorificial.

 Vulgaris: Widely distributed depigmentation that is characterised by scattered nature.

 Mixed: In this type of vitiligo, Acrofacial and vulgaris types occur together or a combination of segmental and acrofacial types and/or vulgaris types of vitiligo occur in different combinations together giving rise to a mixed pattern of vitiligo.

3. Universal vitiligo: Total or near complete lesions of depigmentation are seen in some types of vitiligo, known as Universal vitiligo. It often occurs in subjects with multiple Endocrinopathies syndrome suggesting an association between them.

CLASSIFICATION OF VITILIGO BY THE PROGRESSION OF DISEASE , IT’S PROGNOSIS, AND TREATMENT:

Based on the criteria of progression, treatment and prognosis of the disease, vitiligo can be divided into 2 major types:

A. SEGMENTAL and B. NONSEGMENTAL

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A. SEGMENTAL VITILIGO:

This is characterised by an early onset, rapid spread of the lesions in the affected area. Suddenly this course can arrest, and these depigmented patches can remain persistent and unchanged throughout the patient‘s life.

B. NONSEGMENTAL VITILIGO:

It comprises of all vitiligo, except the types of segmental vitiligo.¹⁸

―A single-center study of 213 patients aged 17 years or younger with segmental or nonsegmental vitiligo found that nonsegmental vitiligo was more strongly linked than segmental vitiligo to markers of autoimmunity or inflammation such as halo naevi and thyroid antibodies; patients with nonsegmental vitiligo were also more likely to have a family history of vitiligo or autoimmunity.‖¹⁹

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ASSESSING THE SEVERITY OF VITILIGO:

The Severity of Vitilgo can be assessed by two indices, ―Vitiligo area severity index (VASI)²⁰ and Vitiligo disease activity score (VIDA)²¹”.

 VITILIGO AREA SEVERITY INDEX

The percentage of involvement of VITILIGO is calculated “in terms of hand units”. One hand unit (defined as the unit comprising of the area of the palm in addition to the area of volar surface of all the digits) can be defined as the area equal to about one percentage of the total body surface area.

Based on the degree of pigmentation, it is approximated to any of the following categories and defined as follows:

100% - Total depigmentation, no trace of pigment is seen;

90% - Presence of specks of pigment; less than complete depigmentation;

75% - Here amount of depigmented area is well above than the pigmented area;

50% - When Pigmentation and Depigmentation are equal;

25% - Here areas of Pigmentation well exceed the areas of depigmentation; and 10% - only specks of areas of depigmentation seen.

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―For every body region, VASI is determined by multiplying the area of vitiligo in terms of hand units and also the extent of depigmentation as determined within each hand unit measured patch‖.

“Total body VASI = Σ All body sites [Hand Units] × [Residual depigmentation”

 VITILIGO DISEASE ACTIVITY SCORE (VIDA)

This VIDA score is a six-point scoring system, where the activity of Vitiligo is scored in terms of the subject‘s own opinion about his/ her disease activity that occurs over time. Vitiligo, when it is active, it expresses itself as either expansion of the present lesions or it may also present as appearance of lesions, which are new.

The Grading is characterised as follows:

―VIDA Score of +4 – Activity of 6 weeks or less duration;

+3 – Activity of 6 weeks to 3 months;

+2 –Activity of 3 - 6 months;

+1 – Activity of 6 - 12 months;

0 - Stable for 1 year or more; and

-1 - Stable with spontaneous repigmentation >/= 1 year‖

Base on this scoring, the activity of the disease can be determined as a low VIDA score indicating a less activity and a high score a high activity.

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QUALITY OF LIFE IN VITILIGO:

World Health Organization has defined quality of life as "individuals' perceptions of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns."²² Chronic conditions of skin can have a huge impact on a patient's QOL beyond only the involvement of the skin²³ as presence of the lesions on the skin significantly affect their cosmetic sense, their self-esteem and as a result their self-confidence and also the social relationships²⁴.

The intensity of how much a person‘s QOL is affected, is extremely variable, depending on the individual person and also on the natural history of the disorder; the subject‘s demographic characteristics such as the age, sex, place of origin and residence, his/ her personality and character, and traditional values and habits; the subject‘s life situation; and the persons surrounding them and their attitudes in the so called society²⁵.

Therefore exploration of quality of life is especially relevant for diseases with dermatological concern to understand the actual impact of the disease in terms of his social life and normal life besides only the treatment given from the medical point of view and to improve the quality of care that is given to the subject.

Mental health in subjects suffering from VITILIGO is generally poor, leading to a significant decrease in QOL. The condition Vitiligo has a major impact such that many feel stigmatized by their condition. Many of vitiligo patients are anxious, get

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depressed and frustrated, and feel embarrassed when they meet strangers and have disturbances in their interpersonal relations in the society or while beginning a new sexual relationship.

In order to accomplish this objective, it is essential to obtain a patient-centered measurement of quality of life. Henceforth, an extensively validated survey form, the

―Dermatology Life Quality Index (DLQI) questionnaire‖ is being used all around the world.

Vitiligo symbolizes an emblematic case, habitually spoiling and misdiagnosed as leprosy. Frequently regarded as an innocuous ornamental problem, the significance of treating subject with vitiligo is habitually underrated²⁶.

Even though the disease does not yield direct physical weakening but it could considerably affect the psychological comfort of the subjects. The disease load comprises of Anxiety, stigmatization, dejection, impairment of quality of life, depression, dearth of self-confidence, frequent embarrassment. Suicide attempts²⁷ have also been recorded from subjects with vitiligo having a poorer QOL and who are always in a state of depression as a consequence of the disease . The families of patients regularly have their lives impaired as a result of the patient‘s miserable condition and its social outcome.²⁸

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DLQI was the principal dermatology-specific quality of life tool, developed in 1994 for the first time .In over 80 countries around the world, and accessible in more than 90 different languages, it has been regularly used and about 1000 publications have come out with this DLQI with many being from multinational studies ²⁹.

The Dermatology Life Quality of Index questionnaire ^30,31,32 is intended for practical use in patients aged above 16. This questionnaire is self-explanatory , so that it could be simply given to the subject , who is requested to fill it devoid of the need for exhaustive explanation as it is very simple.

―DLQI questionnaire is classified into 10 questions and each question with 4 possible answers scored from 0 to 3. The DLQI score is calculated by summing the scores of all the questions, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired‖.

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Interpretation of the score is being done as follows:

DLQI score Interpretation of the score 0-1 ―No effect at all on patient‘s life‖

2-5 ―Small effect on patient‘s life‖

6-10 ―Moderate effect on patient‘s life‖

11-20 ―Very large effect on patient‘s life‖

21-30 ―Extremely large effect on patient‘s life‖

The Quality of life is generally compromised in subjects with vitiligo.

Females have a poorer QOL and it has been reported to be more impaired in younger patients as per the study done by Sharath Kumar et al ³³.

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SOCIOECONOMIC STATUS SCALE

Socioeconomic status (SES) is a significant factor of wellbeing, health, nutritional status, impermanence, and disease of an individual. SES also influences the availability, affordability, appropriateness, and authentic consumption of obtainable health services. There are various diverse scales to quantify the SES of an individual^34,35.

The Modified Kuppuswamy scale is universally used to measure SES in municipal populations. ―The Kuppuswamy scale was developed by Kuppuswamy in 1976 and is based on a amalgamated score in view of the education and occupation of the head of the family along with monthly income of the family, which yields a score‖ ^36,37. This scale categorizes the study populations into five classes, as shown in the following.

Modification of the original scale to bring the earnings subscale up to date is done as required. This was demanded as monetary increase means that the rupee does not maintain the same value each year in terms of the goods/services that may be procured with the same amount. So the income part of the scale is modified every year based on All India Average Consumer Price Index (AIACPI). The current study used the scale updated for the year 2016^38,39,40. The components of Modified Kuppuswamy scale were as follows.

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“MODIFIED KUPPUSWAMY SCALE [updated for February 2016]

CURRENT AIACPI = 267

EDUCATION OF HEAD OF THE FAMILY SCORE

Profession or Honours 7

Graduate or post graduate 6

Intermediate or post high school diploma 5

High school certificate 4

Middle school certificate 3

Primary school certificate 2

Illiterate 1

OCCUPATION OF HEAD OF THE FAMILY SCORE

Profession 10

Semi-Profession 6

Clerical, Shop-owner, Farmer 5

Skilled worker 4

Semi-skilled worker 3

Unskilled worker 2

Unemployed 1

38

MODIFIED KUPPUSWAMY SCALE [updated for FEB 2016]

CURRENT AIACPI = 267

TOTAL FAMILY INCOME PER MONTH SCORE

≥ Rs.41,179 12

Rs.20,590 - Rs.41,178 10

Rs.15,442 - Rs.20,589 6

Rs.10,295 - Rs.15,441 4

Rs.6,177- Rs.10,294 3

Rs.2080 - Rs.6176 2

≤ Rs.2079 1

SOCIO ECONOMIC CLASS TOTAL SCORE

UPPER UPPER [I] 26-29

MIDDLE UPPER MIDDLE [II] 16-25

LOWER MIDDLE [III] 11-15

LOWER UPPER LOWER [IV] 5-10

LOWER [V] <5 ”

39

AIM AND OBJECTIVES

40

AIM AND OBJECTIVES

AIM

To assess the Quality of life among Vitiligo patients attending Vitiligo clinic in Dermatology Outpatient Department in a Medical College Hospital, Chennai, Tamilnadu.

OBJECTIVES

1) To study the Quality of life among Vitiligo patients attending Vitiligo clinic in Dermatology Outpatient Department in a Medical College Hospital.

2) To study the socio-economic and demographic characteristics of the Vitiligo patients.

3) To determine the association between the quality of life and various variables in Vitiligo patients.

41

MATERIALS AND METHODS

42

STUDY AREA:

The study was conducted among the Vitiligo patients attending Vitiligo clinic in Dermatology Outpatient Department, Institute of Dermatology, Madras Medical College

& Rajiv Gandhi Government General Hospital, Chennai. It is located in E.V.R Periyar Salai, Park Town, Chennai - 600 003.

Figure:1&2 showing geographical location of the study area

43

STUDY POPULATION:

The study population included the Vitiligo patients attending Vitiligo clinic in Dermatology Outpatient Department, Institute of Dermatology, Madras Medical College

& Rajiv Gandhi Government General Hospital, Chennai.

TIME LINE:

The study work is described in detail in the following Henry Gantt chart from its inception to the completion.

Activity

2014 2015 2016

8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 Protocol

preparation, Submission,

Ethical clearance Questionnaire

Preparation

Pretesting

Data Collection

Data Entry &

Analysis

Thesis finalization

STUDY PERIOD:

The data collection for the study was done between August 2015 to July 2016.

44

SAMPLE SIZE:

One hundred (100) Vitiligo patients who attended the Department of Dermatology from August 2015 to July 2016 were included in the cross-sectional hospital based study depending on inclusion and exclusion criteria.

INCLUSION CRITERIA:

Patients of all age group attending Vitiligo clinic.

EXCLUSION CRITERIA:

1. Individuals who did not give consent.

2. Individuals who were seriously ill.

STUDY DESIGN:

It was a Hospital based Cross sectional Analytical study.

SAMPLING DESIGN:

Purposive or Convenient sampling design was applied in the current study.

45

STUDY TECHNIQUE

The following flow chart shows an overview of thesis from inception to submission.

Protocol was prepared according to the guidelines provided by The Tamilnadu Dr.M.G.R. Medical University, Tamilnadu and was presented in

the Dept. of Dermatology, Madras Medical College.

The final protocol was submitted to the Ethics Committee of Madras Medical College. After obtaining Ethical Clearance, the protocol was

submitted to the university.

All the study patients were enrolled in the study after explaining the purpose and importance of the study.

Informed consent was obtained from the willing patients.

DATA COLLECTION

Socio economic and Demographic characteristics of the study patients were collected using the proforma. Clinical examinations were done in

the meantime.

Data was verified, entered in Microsoft Excel spread sheet 2010 and was analysed using SPSS Statistical Software version 22.0

46

STUDY TOOLS

A Pre-Designed Pre-Tested Proforma

A standardized semi-structured proforma was developed reviewing the questionnaires and scales which have been used in the similar earlier studies and from different articles related to Quality of Life of Vitiligo patients like VASI (Vitiligo Area Severity Index), VIDA (Vitiligo Disease Activity Score) and DLQI (Dermatology Life Quality Index) which were described later. The questions were directed towards gaining information regarding demographic data like age, gender, marital status, occupation, and per capita income. It also included details about type, localization, stability and duration of Vitiligo, history of treatment, regularity of treatment etc.

47

DEFINITIONS

VARIABLES DEFINITIONS SCALES/SCORES

Age The length of time one has existed after birth

(In Completed years)

Continuous

Gender The range of physical, mental and behavioural characteristics distinguishing between masculinity and femininity

Binomial Male/female

Marital status the civil status of each individual in relation to the marriage laws or customs of the country

Nominal

Unmarried/currently married/

widowed/divorced Education status Level of attainment of education by the

individual in school or colleges or universities.

Ordinal

Illiterate/ Primary / Middle/

Secondary

Higher Secondary school completed/

Graduate/

Postgraduate

48

DEFINITIONS

VARIABLES DEFINITIONS SCALES/SCORES

Occupation An activity that serves as one‘s regular source of livelihood.

Nominal

Farmers / Daily wages/ homemaker/

unemployed/ others Per capita income

(PCI)

total income of a family/total no. of members of the family

(In rupees)

Continuous

Socio economic status based on Modified

Kuppuswamy scale 2016⁽⁶⁹⁾

UPPER

UPPER MIDDLE LOWER MIDDLE UPPER LOWER LOWER

Ordinal

49

STATISTICAL ANALYSIS

All the data was initially entered to Microsoft Excel 2010 and later these spreadsheets were used for analysis. Statistical analysis was done using SPSS version 22.0.

1. DESCRIPTIVE STATISTICS:

Descriptive statistics were calculated as frequency, percentage, mean and standard deviation, median and inter-quartile range. Descriptive data were represented using various tables, graphs, diagrams etc.

2. INFERENTIAL STATISTICS:

For inferential statistics, various tests of significance were used according to the type of variables dealt with. For all the statistical tests of significance, p value of

<0.05 was considered to reject the null hypothesis. Independent sample ‗t‘ test was used to compare the mean DLQI scores with other variables.

3. TESTS FOR NORMALITY:

Shapiro –Wilk Test and Kolmogorov Smirnov Tests were used to test whether the data follow normal distributions or not. Since the test was statistically not significant (p=0.679 ie p>0.05), the data follow a normal distribution, and Parametric tests were used.

50

STATISTICAL ANALYSIS

4. CORRELATION BETWEEN DLQI SCORE AND OTHER VARIABLES:

Since the data follow a normal distribution, Pearson‘s Correlation Coefficient was used to test the correlation between DLQI Score and other variables. Correlations were explained using Scatter Diagrams with DLQI Scores in X axis and other variables in Y axis.

5. SIGNIFICANCE LEVEL:

For all the statistical tests of significance, p value of <0.05 was considered to reject the null hypothesis.

51

ETHICAL ISSUES

Participants were made conscious about the nature and the objective of the research study. Then, all the participants of the study were informed that all data provided by them would be kept confidential and that information would be used merely for research or only for academic purposes and not anywhere else. Readiness and signature of the participant subjects to be incorporated in the study were taken on a formerly designed consent form.

Before proceeding into the process of data collection, written consents were attained from all the research participants. They were enlightened in detail about the full picture of the research, the confidentiality part and of their voluntary participation and about their withdrawal at any time of the study, if needed. Institutional Ethics Committee of Madras Medical College studied the proposal for ethical concerns in detail and their approval was then sought after clearing all their concerns and doubts.

52

RESULTS

53

RESULTS

TABLE-1: Distribution of patients according to age (N=100)

Age Number Percent (%)

< 10 10 10

11-20 18 18

21-30 21 21

31-40 25 25

41-50 19 19

51-60 5 5

>60 2 2

Total 100 100

Mean ± SD= 25.37± 3.95 Median (IQR) =25.0(5-61) Comments:

Majority of the patients (25%) were in the age group of 31-40 years

54

0 5 10 15 20 25

< 10 11-20 21-30 31-40 41-50 51-60 >60 10%

18%

21%

25%

19%

5%

2%

AGE GROUP

< 10 11-20 21-30 31-40 41-50 51-60

>60

55

TABLE-2: Distribution of patients according to gender (N=100)

Gender Number Percent (%)

MALE 55 55

FEMALE 45 45

TOTAL 100 100.0

Comments:

Majority of the patients (55%) were females.

56

55%

45%

GENDER

Males

Females

57

TABLE-3: Distribution of patients according to Marital status (N=100)

Marital status Number Percent (%)

Married 62 62

Single 13 13

Not applicable^* 25 25

TOTAL 100 100

*Not applicable includes children

Comments:

Majority of the patients (62%) were Married.

58

13% 62%

25%

MARITAL STATUS

Married Single

Not applicable

59

TABLE-4: Distribution of patients according to Education (N=100)

Education Number Percent (%)

Illiterate 14 14

Primary school completed 21 21

Middle school completed 19 19

Secondary school completed 18 18

Higher Secondary school completed 17 17

Graduate 5 5

Post Graduate 1 1

Not Applicable 5 5

TOTAL 100 100

*Not applicable includes children <4 years

Comments:

Majority of the patients (21%) Have completed Primary school of education.

60

141%

21%

19% 18%

17%

5%

1%

5%

0 5 10 15 20 25

EDUCATION

61

TABLE-5: Distribution of patients according to Occupation (N=100)

Occupation Number Percent (%)

Farmers 21 21

Home makers 35 35

Daily wages 21 21

Unemployed 8 8

Not applicable^* 15 15

TOTAL 100 100

*Not applicable includes children

Comments:

Majority of the patients (35%) were Homemakers.

62

21%

35%

21%

8%

15%

0 5 10 15 20 25 30 35 40

Farmers Home makers Daily wages Unemployed Not applicable

OCCUPATION

63

TABLE-6: Distribution of patients according to Socio Economic Status (Modified Kuppuswamy scale 2016) (N=100)

Socioeconomic class Number Percent (%)

UPPER 0 0

UPPER MIDDLE 20 20

LOWER MIDDLE 23 23

UPPER LOWER 42 42

LOWER 15 15

Total 100 100

Comments:

Majority (42%) belong to Upper Lower Socioeconomic class.

64 0

5 10 15 20 25 30 35 40 45

UPPER UPPER

MIDDLE

LOWER MIDDLE

UPPER LOWER

LOWER

0

20%

23%

42%

15%

SOCIOECONOMIC STATUS

65

TABLE-7: Distribution of patients according to Localization of Vitiligo (N=100)

Localization of Vitiligo Number Percent (%)

Localized 90 90

Generalized 10 10

TOTAL 100 100

Comments:

About 90% of the patients had Localized Vitiligo.

66 90%

10%

LOCALIZATION OF VITILIGO

Localised

Generalized

67

TABLE-8: Distribution of patients according to Stability of Vitiligo (N=100)

Stability of Vitiligo Number Percent (%)

Stable 28 28

Progressive 72 72

TOTAL 100 100

Comments:

About 72% of the patients had Progressive Vitiligo.

68 28%

72%

STABILITY OF VITILIGO

Stable

Progressive

69

TABLE-9: Distribution of patients according to Duration of Vitiligo (N=100)

Duration of Vitiligo Number Percent (%)

<1 year 15 15

1-5 years 59 59

>5 years 26 26

TOTAL 100 100

Comments:

Majority of the patients (59%) had duration of Vitiligo (1-5 years)

70 0

10 20 30 40 50 60

<1 year 1-5 years >5 years

15%

59%

26%

DURATION

71

TABLE-10: Distribution of patients according to Regularity of Treatment (N=100)

Regularity of Treatment Number Percent (%)

Regular 90 90

Irregular 10 10

TOTAL 100 100

Comments:

About 10% of the patients had Irregular treatment.

72 90%

10%

TREATMENT

Regular

Irregular

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TABLE-11: Distribution of patients according to VASI (Vitiligo area severity index) (N=100)

Degree of Depigmentation

VASI (Interpretation) Number Percent (%)

100% Complete

depigmentation, No pigment is present

0 0

90% Specks of pigment present

0 0

75% Depigmented area exceeds the pigmented area

0 0

50% Pigmented and

depigmented areas are equal

2 2

25% Pigmented area exceeds depigmented area

84 84

10% Only specks of

depigmentation present

14 14

TOTAL 100 100

Comments:

Majority of the patients (84%) showed 25% of Degree of Depigmentation ie Pigmented area exceeds depigmented area.

74

0 10 20 30 40 50 60 70 80 90

Complete depigmentation Specks of pigment present Depigmented area exceeds the

pigmented area

Pigmented and depigmented areas are equal

Pigmented area exceeds depigmented area

Only specks of depigmentation present

0 0 0 2

84 16

VASI

75

TABLE-12: Distribution of patients according to VIDA (Vitiligo disease activity score) (N=100)

Grade VIDA (Interpretation) Number Percent (%)

+4 Activity of 6 weeks or less duration

1 1

+3 Activity of 6 weeks to 3 months 3 3

+2 Activity of 3 - 6 months 7 7

+1 Activity of 6 - 12 months 19 19

0 Stable for 1 year or more 60 60

-1 Stable with spontaneous Repigmentation >/- 1 year

10 10

TOTAL 100 100

Comments:

Majority of the patients (60%) showed Grade 0 in VIDA ie Stable for 1 year or more.

76

0 10 20 30 40 50 60

Activity of 6 weeks or less duration Activity of 6 weeks to 3 months Activity of 3 - 6 months Activity of 6 - 12 months Stable for 1 year or more Stable with spontaneous Repigmentation >/- 1 year

1 2

7

19

60 10

VIDA

77

TABLE-13: Distribution of patients according to DLQI (Dermatology Life Quality Index) (N=100)

Score DLQI (Interpretation) Number Percent (%)

0-1 No effect at all on patient’s life 1 1

2-5 Small effect on patient’s life 45 45

6-10 Moderate effect on patient’s life 31 31 11-20 Very large effect on patient’s life 21 21 21-30 Extremely large effect on patient’s life 2 2

TOTAL 100 100

Comments:

Majority of the patients (45%) had DLQI score of 2-5, which interprets Vitiligo had small effect on patient‘s life.

78

0 5 10 15 20 25 30 35 40 45

No effect at all on patient‘s life Small effect on patient‘s life Moderate effect on patient‘s life Very large effect on patient‘s life Extremely large effect on patient‘s life

1

45 31

21 2

DLQI

79

TABLE-14: Descriptive statistics of DLQI Scores (N=100)

Measures DLQI Score

Mean 7.39

SD 2.45

Range 1-30

80

TABLE-15: Comparisons of Mean DLQI scores with other variables (N=100)

S.No. Variables Class No. of

patients

DLQI Score P value

1. Age < 10

11-20 21-30 31-40 41-50 51-60

>60

10 18 21 25 19 5 2

2.17 ± 0.7 3.50 ± 1.1 7.71 ± 2.5 6.92 ± 1.8 9.44 ± 3.8 14.32 ± 3.4 25.73 ± 7.6

0.042^*

2. Gender Male

Female

55 45

7.78 ± 2.1 7.64 ± 1.9

0.591 3. Marital status Married

Unmarried

62 38

4.55 ± 0.9 9.64 ± 4.2

0.037^* 4. Education Illiterate

Educated

14 86

3.33 ± 0.7 14.45 ± 2.7

0.795 5. Occupation Employed

Unemployed

79 21

6.11 ± 3.3 12.34 ± 5.1

0.028^* 6. Socioeconomic

class

UPPER

UPPER MIDDLE LOWER MIDDLE UPPER LOWER LOWER

0 20 23 42 15

--- 5.11 ± 2.6 11.3 ± 1.2 7.86 ± 3.2 20.71 ± 7.9

0.011^*

7. Localization of Vitiligo

Localized Generalized

90 10

4.55 ± 1.8 10.07 ± 6.2

0.751 8. Stabilization of

vitiligo

Stable Progressive

28 72

9.38 ± 3.3 18.10 ± 4.7

0.036^* 9. Duration of

vitiligo

<1 year 1-5 years

>5 years

15 59 26

3.22 ± 0.1 14.74 ± 2.6 22.91 ± 5.7

0.042^*

10. Regularity of treatment

Regular Irregular

90 10

5.33 ± 1.7 11.53 ± 4.1

0.894

*statistically significant at 95% Confidence Interval (p value < 0.05)

81

Comments:

 Variables like age of the patient, gender, marital status, education, occupation, and socioeconomic status, localization of vitiligo, stabilization of vitiligo, duration of vitiligo and regularity of treatment were taken for comparision with the DLQI score.

 Among them, only age, marital status, occupation, SES, stabilization and duration of vitiligo showed statistically significant relation with DLQI.

 It is explained as increasing age, unmarried patients, unemployed patients, lower socioeconomic patients, and patients with progressive type of vitiligo and longer duration of vitiligo (> 5 years) tend to show higher DLQI score. It indicates that they were having a poor quality of life.

82

TABLE-16: Correlation between DLQI score & other continuous variables (N=100)

S.No. Variable r value p value Significance

1. Age 0.651 0.021^* S

2. Duration of Vitiligo 0.501 0.015^* S

3. VASI degree 0.723 0.043^* S

4. VIDA grade 0.618 0.588 NS

*statistically significant at 95% Confidence Interval (p value < 0.05)

83

Figure 3: Scatter Diagram showing Correlation between Age and DLQI Score

The Scatter diagram shows that there was a Positive correlation between Age and DLQI Score which was also statistically significant (p value < 0.05). It could be described that as the age of the patient increases, the DLQI score also tends to increase.

84

Figure 4: Scatter Diagram showing Correlation between Duration of Vitiligo and DLQI Score

The Scatter diagram shows that there was a Positive correlation between Duration of Vitiligo and DLQI Score which was also statistically significant (p value < 0.05). It could be described that as the duration of Vitiligo increases, the DLQI score also tends to increase.