30 listed sites: France (2); Kenya (1); United Kingdom (2); United States (25) - 11 Oct `23Afamelanotide with light therapy for nonsegmental vitiligo

Afamelanotide with light therapy for nonsegmental vitiligo

Official title: A Double-Arm, Open Label, Phase III Study to Compare the Efficacy and Safety of SCENESSE and Narrow-Band Ultraviolet B (NB-UVB) Light Versus NB-UVB Light Alone in the Treatment of Vitiligo

Status: Closed to new participants

Description:

Clinuvel, Inc. plans to enroll about 200 participants. Afamelanotide activates a pathway that stimulates melanocytes to make more pigment. Used with UVB light, it may speed or increase repigmentation. Afamelanotide is sold as Scenesse and is approved for erythropoietic protoporphyria; vitiligo would be a new use. Possible effects include nausea, headache, skin darkening, and changes in moles. People age 12 and older may qualify. The study is underway but is no longer accepting new participants.

Start date: October 11, 2023

Completion date: June 01, 2026

Organizer: Clinuvel, Inc.

Contact: See contacts and locations in the ClinicalTrials.gov record

Link: https://clinicaltrials.gov/study/NCT06109649

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