Microneedling and Latanoprost in Acrofacial Vitiligo

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-12-01

Brief Summary

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

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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.

Conditions

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Vitiligo

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Microneedling + 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).

Group Type ACTIVE_COMPARATOR

Latanoprost

Intervention Type DRUG

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.

Microneedling

Intervention Type DEVICE

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

latanoprost

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

Group Type ACTIVE_COMPARATOR

Latanoprost

Intervention Type DRUG

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.

Interventions

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Latanoprost

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.

Intervention Type DRUG

Microneedling

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

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No