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

Phase 4

• Conditions: Excimer Laser; Fractional CO2 Laser; Vitiligo
• Interventions: 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

• Registration Number: NCT04577027
• Lead Sponsor: Assiut University

Brief Summary

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

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.

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-26
• Study First Submitted QC: 2020-09-30
• Study First Posted: 2020-10-06
• Last Update Submitted: 2020-10-19
• Last Update Posted: 2020-10-22
• Study Start: 2021-01-01
• Primary Completion: 2022-01-01
• Study Completion: 2022-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Patients older than 12 years.
2. Patients with generalized non-segmental vitiligo.
3. No previous treatment for vitiligo in the last 1 month.
4. Patients who were unresponsive to medical treatment or photo therapy for at least 3 months.

Exclusion Criteria

1. Patients with sensitivity to travoprost.
2. Patients with photosensitivity.
3. Patients with history or active skin cancer.
4. No other dermatological or systemic diseases.
5. Active infections .
6. Pregnant or lactating females.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
vitiligo patients	Topical travoprost 0.004% solution	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.
vitiligo patients	Fractional CO2 laser	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.
vitiligo patients	fractional CO2 laser and topical travoprost	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.
vitiligo patients	Excimer laser	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.
vitiligo patients	Excimer laser and travoprost	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.
vitiligo patients	Combination therapy	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.

Primary Outcome Measures

Name	Time	Method
clinical improvement through VASI score	9 months	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 \[% residual depigmentation\].

Secondary Outcome Measures

Name	Time	Method
Patients satisfaction	9 months	according to the following scale: 1. dissatisfied; 2. neutral; 3. somewhat satisfied; 4. moderately satisfied; 5. very satisfied
percent of repigmentation	9 months	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).
Histopathological evaluation	9 months	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 .