Microneedling and Latanoprost in Acrofacial Vitiligo

Study Overview
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Brief Summary
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To compare efficacy of topical latanoprost preceded by microneedling versus topical latanoprost alone in treatment of acrofacial vitiligo.

Detailed Description
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patients meeting inclusion and exclusion criteria presented to Dermatology Outpatient Clinic, Sohag University Hospital will be enrolled in the study after obtaining a written consent from them. Full history will be obtained and meticulous examination will be carried out. Patients will be randomly divided into 2 groups, one group will receive topical latanoprost with microneedling, and the other one will receive topical latabnoprost alone.

Official Title
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Effectiveness of Microneedling and Topical Latanoprost in Treatment of Acrofacial Vitiligo

Conditions
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Vitiligo

Intervention / Treatment
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* Drug: Latanoprost
* Device: Microneedling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Acrofacial stable vitiligo for 6 months duration (without new lesions appearance or change in size of the existing lesions). Exclusion Criteria: History of scar formation. Patients with systemic diseases (diabetes, bleeding disorders, chronic renal diseases, chronic liver diseases, asthma and hypertension). Patients who are receiving chemotherapy or radiotherapy. Pregnant and lactating females.

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Microneedling + latanoprost<br>patient will receive topical application of latanoprost 0.005% eye drops solution twice daily for 3 months preceded by microneeding in sessions by dermapen every 2 weeks for 3 months (totally 6 sessions). | Drug: Latanoprost<br>* Topical application of latanoprost 0.005% eye drops solution only twice daily for 3 months. To apply latanoprost solution, one drop of the solution will be distributed over 1cm2 of depigmented skin. Side effects will be recorded.<br>Device: Microneedling<br>* A superficial micro-needling technique will be done in millimeters according to depth of skin. The vitiliginous area and a thin surrounding rim (about 2 mm) will be subjected to micro-needling with dermapen. The depth of abrasion will be guided by the depth adjustor according to depth of skin on the affected area. This will be followed by the appearance of multiple, tiny, punctate, bleeding points<br>|
| Active Comparator: latanoprost<br>Patient will receive topical application of latanoprost 0.005% eye drops solution only twice daily for 3 months (active control side). | Drug: Latanoprost<br>* Topical application of latanoprost 0.005% eye drops solution only twice daily for 3 months. To apply latanoprost solution, one drop of the solution will be distributed over 1cm2 of depigmented skin. Side effects will be recorded.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in VASI score | VASI score: The percentage of vitiligo involvement is calculated in terms of hand units. One hand unit is approximately equivalent to 1% of the total body surface area. The degree of pigmentation is estimated to the nearest of one of the following percentages: 100% - complete depigmentation, no pigment is present 90% - specks of pigment present 75% - depigmented area exceeds the pigmented area 50% - pigmented and depigmented areas are equal 25% - pigmented area exceeds depigmented area 10% - only specks of depigmentation present. The VASI for each body region is determined by the product of the area of vitiligo in hand units and the extent of depigmentation within each hand unit measured patch. Total body VASI = S All body sites [Hand Units] x [Residual depigmentation]. (Feily et al., 2014). | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acrofacal vitiligo, latanoprost, microneedling