At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 21 enrolled
Drug / intervention
Afamelanotide +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Two-Arm, Randomized, Double-Blind, Phase IIb Study to Compare the Efficacy and Safety of Subcutaneous, Bioresorbable Afamelanotide Implants Plus Narrow-Band Ultraviolet B (NB-UVB) Light Source With Narrow-Band Ultraviolet B (NB-UVB) Light Source in the Treatment of Nonsegmental Vitiligo AND A Single-Arm, Open Label, Phase IIb Study to Evaluate the Efficacy and Safety of Subcutaneous, Bioresorbable Afamelanotide Implants Plus Narrow-Band Ultraviolet B (NB-UVB) Light Source in the Treatment of Nonsegmental Vitiligo
In Brief
A Phase 2 clinical trial evaluating Afamelanotide and Placebo for Vitiligo. Completed, enrolled 21 participants.
Detailed Summary
The purpose of this study was to evaluate the efficacy and safety of afamelanotide, when combined with narrowband ultraviolet B (NB-UVB) phototherapy, in patients with nonsegmental vitiligo. Afamelanotide is expected to increase the rate of the repigmentation induced by NB-UVB, leading to a reduced frequency and dose of NB-UVB.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVitiligo
Countries--
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartJun 2014
Primary CompletionFeb 2016
Study CompletionJun 2016
First PostedAug 2020
TodayJul 2026
First PostedAug 25, 2020
Enrollment StartJun 6, 2014
Primary CompletionFeb 2, 2016
Study CompletionJun 6, 2016
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 5.9 years ago
Interventions
Afamelanotidedrug
Placebodrug