Microneedling and Latanoprost in Acrofacial Vitiligo

Phase 2

• Conditions: Vitiligo
• Interventions: Drug: Latanoprost; Device: Microneedling

• Registration Number: NCT03611348
• Lead Sponsor: Sohag University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-07-26
• Study First Submitted QC: 2018-07-26
• Status Verified: 2018-08
• Study First Posted: 2018-08-02
• Last Update Submitted: 2018-08-26
• Last Update Posted: 2018-08-28
• Study Start: 2018-09-01
• Primary Completion: 2019-09-01
• Study Completion: 2019-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Microneedling + latanoprost	Microneedling	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).
Microneedling + latanoprost	Latanoprost	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).
latanoprost	Latanoprost	Patient will receive topical application of latanoprost 0.005% eye drops solution only twice daily for 3 months (active control side).

Primary Outcome Measures

Name	Time	Method
Improvement in VASI score	6 months	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).