Bimatoprost 0.03% Solution With NB-UVB Versus Their Use With Fractional Carbon Dioxide Laser in Treatment of Generalized Vitiligo

Phase 4

• Conditions: Generalized Vitiligo
• Interventions: Drug: Bimatoprost 0.03% ophthalmic solution

• Registration Number: NCT03487042
• Lead Sponsor: Assiut University

Brief Summary

Vitiligo is a chronic disorder of pigmentation characterized by the development of white macules on the skin due to loss of epidermal melanocytes. It affects approximately 0.5%-2% of general population world-wide, without predilection for sex or race.Vitiligo can be classified into segmental or non-segmental. Non-segmental or generalized vitiligo is the most common clinical presentation and often involves the face and acral regions.

Multiple monotherapy modalities are established to treat vitiligo but the response is variable, unsatisfactory, and requiring a prolonged course. This problem is exaggerated by the multifactorial and polygenic nature of the pathomechanism of the disease. These facts pave the way to combination therapy that showed better and safe repigmentation response than monotherapy.

Detailed Description

Bimatoprost 0.03% ophthalmic solution is a synthetic prostaglandin F2 alpha analog that is approved for the treatment of glaucoma and eyelashes hypotrichosis (Lee et al, 2017). Cutaneous hyperpigmentation of the treated sites has been reported as a side effect with this agent. Phototherapy (narrow band ultraviolet B (NB-UVB)) of wavelength 308 nm, is considered as a successful method of treatment of vitiligo. The cytotoxic T-cells accountable for the destruction of melanocytes and disappearance of melanin are eliminated by phototherapy through apoptosis (diffuse repigmentation) and UVB does stimulate melanocytic proliferation and their migration to the epidermis from nearby follicular units (follicular repigmentation) and perilesional active melanocytes (marginal repigmentation).

In recent years, fractional carbon dioxide laser has been introduced as an add-on treatment for vitiligo. It represents a new modality for skin resurfacing based on the theory of fractional photothermolysis. The beneficial effect of fractional carbon dioxide laser on vitiligo is the release of cytokines and growth factors that act as mitogens for melanogenesis. It also alters the skin barrier, which results in increased penetration of topical drugs and ultraviolet (UV) radiation, so it can be used in combination therapy.

Study Timeline

• Status Verified: 2018-03
• Study First Submitted: 2018-03-11
• Study First Submitted QC: 2018-03-27
• Last Update Submitted: 2018-03-27
• Study First Posted: 2018-04-03
• Last Update Posted: 2018-04-03
• Study Start: 2018-05
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Patients older than 12.
2. Patients with non-segmental vitiligo.
3. Lesions stable for at least one year.
4. Patients who were unresponsive to medical treatment or photo therapy for at least 3 months.
5. No sex or site predilection.
6. Bilateral and symmetrical lesions with maximum size of 10×10 cm.

Exclusion Criteria

1. Patients with active infection.
2. Patients with sensitivity to bimatoprost or photosensitivity.
3. Patients with history or active skin cancer.
4. Pregnant or lactating females.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Generalized vitiligo patients	Bimatoprost 0.03% ophthalmic solution	Each patient with generalized vitiligo will be subjected to the following: One side will be treated by narrow band ultraviolet rays sessions twice weekly for 3 months + topical bimatoprost 0.03% ophthalmic solution solution twice daily ( 1 drop for each 2 cm2 ) and the other side will be treated by topical bimatoprost 0.03% ophthalmic solution twice daily ( 1 drop for each 2 cm2 ) + narrow band ultraviolet rays sessions twice weekly for 3 months + 10.600-nm fractional carbon dioxide laser sessions twice monthly for 3 months.

Primary Outcome Measures

Name	Time	Method
Frequency and types of side effects	3 months	Frequency and types of side effects.
Repigmentation of skin lesions	3 months	Patients will be followed up by two blind dermatologists after 3 months to detect: The percent of repigmentation: that will be subjectively rated with a previously reported scoring system: * \< 25% repigmentation (poor).; * 25-50% repigmentation (fair).; * 50-75% repigmentation (good). -\> 75% repigmentation (excellent).

Secondary Outcome Measures

Name	Time	Method
Vitiligo area scoring index score	3 months	Vitiligo area scoring index score percent change will be calculated by subtracting the pre- procedure vitiligo area scoring index score from the post-procedure vitiligo area scoring index score and dividing by the pre-procedure vitiligo area scoring index score.
Patient satisfaction	6 months	The patient overall satisfaction will be assessed after 6 months according to Wong Overall satisfaction: 1. dissatisfied; 2. neutral; 3. somewhat satisfied; 4. moderately satisfied; 5. very satisfied