At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 31 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 Phase III, Randomised, Double Blind, Placebo Controlled, Parallel Group Study, to Evaluate the Safety and Efficacy of Subcutaneous Implants of Afamelanotide (16 mg) in Patients Suffering From Polymorphic Light Eruption (PLE)
In Brief
A Phase 3 clinical trial evaluating Afamelanotide and Placebo for Polymorphic Light Eruption. Completed, enrolled 31 participants.
Detailed Summary
This study was to evaluate the safety and efficacy of afamelanotide in patients suffering from polymorphic light eruption (PLE).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPolymorphic Light Eruption
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2010
Primary CompletionDec 2010
First PostedJan 2021
TodayJul 2026
First PostedJan 12, 2021
Enrollment StartMay 5, 2010
Primary CompletionDec 9, 2010
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 5.5 years ago
Interventions
Afamelanotidedrug
Placebodrug