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

Assiut University

Status and phase: Unknown; Phase 4

Conditions: Fractional CO2 Laser; Excimer Laser; Vitiligo

Treatments: Other: Excimer laser and travoprost; Drug: Topical travoprost 0.004% solution; Other: Combination therapy; Other: fractional CO2 laser and topical travoprost; Device: Excimer laser; Device: Fractional CO2 laser

Study type: Interventional

Funder types: Other

Identifiers

NCT04577027

FETV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 12 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

vitiligo patients

Experimental group

Description:

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.

Treatment:

Device: Excimer laser

Other: fractional CO2 laser and topical travoprost

Device: Fractional CO2 laser

Other: Combination therapy

Other: Excimer laser and travoprost

Drug: Topical travoprost 0.004% solution