At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 169 enrolled
Drug / intervention
SD-101-6.0 cream +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 3, Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of SD-101 Cream in Patients With Epidermolysis Bullosa
In Brief
A Phase 3 clinical trial evaluating SD-101-6.0 cream and Placebo (SD-101-0.0) cream for Epidermolysis Bullosa. Completed, enrolled 169 participants across 38 sites in 13 countries.
Detailed Summary
The aim was to assess the efficacy and safety of SD-101-6.0 cream versus Placebo (SD-101-0.0) cream in the treatment of skin lesions in participants with Epidermolysis Bullosa. Funding Source - United States Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpidermolysis Bullosa
CountriesAustralia, Austria, France, Germany, Israel, Italy, Lithuania, Netherlands, Poland, Serbia, Spain, United Kingdom, United States
CollaboratorsAmicus Therapeutics
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 2015
Enrollment StartMar 2015
Primary CompletionJul 2017
TodayJul 2026
First PostedMar 10, 2015
Enrollment StartMar 11, 2015
Primary CompletionJul 5, 2017
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 11.3 years ago
Interventions
SD-101-6.0 creamdrug
applied topically once a day for 90 days
Placebo (SD-101-0.0) creamdrug
applied topically once a day for 90 days