Uniform continuity

Physical examination was conducted for the patients and control group, individually, in a well lit room, during which the integumentary system was examined for any abnormality.

A wood’s lamp was used for both the patients and control group because in lightly pigmented individuals depigmented lesions are not readily apparent in them and also to detect depigmented lesions on the palms of the hands and plantar aspects of the feet.

The diagnosis of vitiligo was made based on the findings of depigmented macules and/or patches with sharply demarcated margins, normal texture, intact sensation and no scaling.

The classification of Vitiligo for the study was based on the Vitiligo Global Issues Consensus Conference classification adopted in 2011⁴⁸.

The classes are:

SEGMENTAL VITILIGO (SV): refers to an unambiguous distribution of depigmented lesions on one side of the body typically associated with rapid onset and with leukotrichia.

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NON-SEGMENTAL VITILIGO (NSV): refers to all other subtypes of vitiligo that are clearly distinct from Segmental Vitiligo such as

1. Generalised vitiligo: This form of vitiligo is characterized by asymptomatic, well-circumscribed, milky-white macules involving multiple parts of the body, usually in a symmetrical pattern.

2. Acrofacial vitiligo: The distinctive feature here is depigmentation of the distal extremeties and facial orifices.

3. Vitiligo universalis: This is the most extensive form of Vitiligo and the total body surface area affected here is 80-90%.

4. Mucosal vitiligo: In this form, there is involvement of more than one mucosal site.

5. Mixed vitiligo: This refers to the concomitant occurrence of SV and NSV.

UNCLASSIFIED VITILIGO are subtypes of vitiligo that do not fit into SV or NSV such as Mucosal vitiligo: Isolated involvement of one mucosal site which has not evolved into NSV After a period of –at least 2 years.

Focal vitiligo: refers to a small isolated patch that does not fit a segmental distribution and which has not evolved after a period of at least 2 years.

In this study, the extent of the loss in skin pigment was calculated based on the rule of nine Which was adopted by the Vitiligo European Task Force^66. The head and neck represents 9%

(face represents 4.5%), anterior trunk 18%, posterior trunk 18%, right lower limb 18%, left lower limb 18%, right upper limb 9%, left upper limb 9%, genitals 1% which sums up to 100%.The total BSA affected was calculated as a sum of the percentages obtained in all the affected parts of the body. Patients with ≤ 20% of BSA affected were classified as having limited disease and those with > 20% of BSA affected were classified as having extensive disease.

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Treatment options such as Narrow Band UVB, PUVA and PUVAsol (meladinine solution/

tablets + natural sunlight) were offered to the patients because photo/photochemotherapy is a recommended modality for the treatment of vitiligo. However, PUVAsol was chosen because the meladinine solution/tablets were readily available and inexpensive. Moreso, there was no UVA phototherapy unit nor-treatment facilities for Narrow Band UVB therapy at the hospital or any of the nearby hospitals during the period.

Patients with limited disease were given topical PUVAsol (0.1% meladinine solution). The solution was diluted in 60% alcohol in the ratio 1:9 to get a concentration of 0.01% ⁶⁷. This is to prevent patients from having severe erythema (pinkish discoloration of depigmented skin which persists for more than 24 hours) after topical application.

The dilution was done and demonstrated for each patient in the clinic. The solution was applied 30 minutes before sun exposure to early morning sunlight (between 6am – 7am) for a period of 10 to 15 minutes. The duration of exposure was graded (reduced or increased) depending on the severity of erythema as the aim was to achieve erythema for a period not more than 24 hours. Patients were asked to reduce the time of sun exposure by five minutes if they developed severe erythema.Therapy was repeated on alternate days and outcome was checked at each return visit (every 2 months) to the Dermatology clinic which runs on Thursdays for a period of 6 months.

Patients with extensive disease were given oral PUVAsol (meladinine tablets). Each tablet has a strength of 10mg and the dose for each patient was calculated based on body weight at 0.2 to 0.4mg per Kg body weight. The tablets were taken one to two hours prior to sun exposure (early morning sunlight between 6am – 7am) for a period of 10 to 15 minutes. The duration of exposure was also graded (reduced or increased) depending on the severity of erythema as the aim was to achieve erythema for a period not more than 24 hours.

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Patients were asked to reduce the time of sun exposure by five minutes if they developed severe erythema. Therapy was repeated on alternate days and outcome was checked at each return visit (every 2 months) to the Dermatology clinic which runs on Thursdays for a period of 6 months. The patients were also asked to wear dark goggles during treatment to protect the eyes from the effects of Ultra-Violet radiation and also to apply sunscreen creams on the exposed parts of the body after treatment.

The treatment outcomes for all the patients treated were classified into 3 categories:

Progressed (P), Stable(S) and Repigmented (R). Repigmented lesions were further sub-divided into R1 (<50% of BSA) and R2 (>50% of BSA) to represent the percentage of the Body Surface Area affected by vitiligo that got repigmented in relation to the initial area affected.

This was a contextual provision by the investigator to be able to easily assess the degree of repigmentation achieved. Other systems of the body were examined to exclude other conditions such as hyper/hypothyroidism, alopecia and anaemia.

The patients were also requested to come to the Eye and ENT clinics 2 weeks after initial presentation for the ocular and ear examinations. The appointments were on Thursdays which was the day of the week that was chosen by the investigator, Ophthalmologist and Otorhinolaryngologist to reduce the burden of transportation on the patients and also enhance the multi-disciplinary management.

To screen for ocular disorders, a detailed eye examination which included slit-lamp examination and fundoscopy to check for abnormalities in the anterior chamber and retina of the eyes was done by an Ophthalmologist and the investigator on all the patients.

To screen for auditory disorders, external ear examination, otoscopy, Weber’s test and Rinne’s tests were done to detect any abnormalities before patients were taken to a sound treated room for Pure Tone Audiometry performed by an Otorhinolaryngologist.

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The Pure Tone Audiometry was done using a standard calibrated clinical audiometer. Hearing levels were measured at different frequencies from 0.25 to 8.0 KHz. The Pure Tone Average was calculated as the arithmetic mean for the Air Conduction tracings at 0.5 KHz, 1KHz, 2KHz and 4KHz. A value above 25 deciBels(dB) was regarded as significant for hypoacusis^68.