Effect Of Topical Prostaglandin F2α Analogs,Fractional CO2 Laser, Excimer Laser Or Their Combination In Treatment Of Vitiligo

Study Overview
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Brief Summary
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Vitiligo is a chronic disease with an unpredictable clinical course, characterized by the appearance of white macules and patches on the skin and mucous membranes due to the disappearance of melanocytes in the affected area. It affects approximately 0.5% - 2% of the population worldwide and may occur at any age. Vitiligo is caused by a dynamic interplay between genetic and environmental risks that initiates an autoimmune attack on melanocytes in the skin.

Detailed Description
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The treatment of vitiligo has been a challenge for dermatologists. Recent reports have highlighted darkening of iris, and eyelashes and periocular hyperpigmentation induced by prostaglandin F2α analogues used for the treatment of glaucoma (as travoprost). Extrapolating these findings in the treatment of vitiligo. The beneficial effect of fractional CO2 laser on vitiligo is postulated to come from the release of cytokines and growth factors that act as mitogens for melanogenesis . The preceding laser also alters the skin barrier, which results in increased penetration of topical drugs and ultraviolet (UV) radiation. 308 nm excimer laser is a monochromatic, target type treatment and allows the delivery of higher fluences to the lesions and avoids damage to the surrounding normal skin resulting in a faster and more effective pigmentation with minimal side effects.

Official Title
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Safety And Efficacy Of Topical Prostaglandin F2α Analogs In Combination With Fractional CO2 Laser And 308 Excimer Light In Treatment Of Vitiligo

Conditions
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Vitiligo, Excimer Laser, Fractional CO2 Laser

Intervention / Treatment
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* Drug: Topical travoprost 0.004% solution
* Device: Fractional CO2 laser
* Device: Excimer laser
* Other: Combination therapy
* Other: Excimer laser and travoprost
* Other: fractional CO2 laser and topical travoprost


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 12 years. Patients with generalized non-segmental vitiligo. No previous treatment for vitiligo in the last 1 month. Patients who were unresponsive to medical treatment or photo therapy for at least 3 months. Exclusion Criteria: Patients with sensitivity to travoprost. Patients with photosensitivity. Patients with history or active skin cancer. No other dermatological or systemic diseases. Active infections . Pregnant or lactating females.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vitiligo patients<br>Thirty Patients complaining of generalized non segmental vitiligo will be recruited in this study. They will be chosen from the attendants of the out-patient clinics of Dermatology, Assiut university hospital. six patches will be selected in each patient. | Drug: Topical travoprost 0.004% solution<br>* 30 Patches treated with Topical Travoprost 0.004% solution: Topical travoprost 0.004% solution once daily (1 drop for each 2.5 x 2.5 cm2) for 3 months.<br>Device: Fractional CO2 laser<br>* 30 Patches treated with Fractional CO2 laser: Fractional CO2 laser sessions twice monthly for 3 months, parameters settings as follows: Energy\ dot 100mj, pulse duration 5ms, density level 17, pattern: array, depth level 1, 2 passes used<br>Device: Excimer laser<br>* 30 Patches treated with Excimer laser: Excimer laser sessions will be repeated twice weekly on the selected patch only, The starting dose will be 200 mj /cm2, an increase of 100 mJ/cm2 in the following session if no erythema appears, an increase of 50 mJ/cm2 every session till the appearance of erythema that lasts 24 hours or more.<br>Other: Combination therapy<br>* 30 Patches treated with Combination therapy: Fractional CO2 laser twice per month followed by application of topical travoprost 0,004% daily and excimer laser twice weekly .<br>Other: Excimer laser and travoprost<br>* 30 Patches treated with Excimer laser twice weekly and topical travoprost once daily for 3 months<br>Other: fractional CO2 laser and topical travoprost<br>* 30 Patches treated with fractional CO2 laser twice monthly and topical travoprost once daily for 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical improvement through VASI score | VASI score will be calculated for each patient at start, every 4 weeks and 6 months after the last session. VASI = ∑ all treated sites [number of hand units] X [% residual depigmentation]. | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients satisfaction | according to the following scale: dissatisfied neutral somewhat satisfied moderately satisfied very satisfied | 9 months | 
| percent of repigmentation | The percent of repigmentation will be calculated every 4 weeks of treatment and 6 months after the last session by a scoring system . < 25% repigmentation (poor response). 25-50% repigmentation (fair response). 50-75% repigmentation (good response). > 75% repigmentation (excellent response). | 9 months | 
| Histopathological evaluation | Skin biopsy will be taken from the treated lesions after treatment, Hematoxylin and eosin-stained slides will be examined microscopically to evaluate the epidermal and dermal pathological changes: (1) evaluation of dermal perivascular inflammatory infiltrate density; (2) signs of pigmentation in the form of residual melanin in epidermis or dermal melanophages . | 9 months |