NCT04577027

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

Safety And Efficacy Of Topical Prostaglandin F2α Analogs In Combination With Fractional CO2 Laser And 308 Excimer Light In Treatment Of Vitiligo

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 12 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vitiligo
• Excimer Laser
• Fractional CO2 Laser

Interventions

Type	Name	Description
DRUG	Topical travoprost 0.004% solution	30 Patches treated with Topical Travoprost 0.004% solution: Topical travoprost 0.004% solution once daily (1 drop for each 2.5 x 2.5 cm2) for 3 months.
DEVICE	Fractional CO2 laser	30 Patches treated with Fractional CO2 laser: Fractional CO2 laser sessions twice monthly for 3 months, parameters settings as follows: Energy\\ dot 100mj, pulse duration 5ms, density level 17, pattern: array, depth level 1, 2 passes used
DEVICE	Excimer laser	30 Patches treated with Excimer laser: Excimer laser sessions will be repeated twice weekly on the selected patch only, The starting dose will be 200 mj /cm2, an increase of 100 mJ/cm2 in the following session if no erythema appears, an increase of 50 mJ/cm2 every session till the appearance of erythema that lasts 24 hours or more.
OTHER	Combination therapy	30 Patches treated with Combination therapy: Fractional CO2 laser twice per month followed by application of topical travoprost 0,004% daily and excimer laser twice weekly .
OTHER	Excimer laser and travoprost	30 Patches treated with Excimer laser twice weekly and topical travoprost once daily for 3 months
OTHER	fractional CO2 laser and topical travoprost	30 Patches treated with fractional CO2 laser twice monthly and topical travoprost once daily for 3 months

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-01-01
• Completion: 2022-04-01
• First posted: 2020-10-06
• Last updated: 2020-10-22