drugset / Trial / NCT02014376

Study of Effectiveness and Safety of SD-101 in Participants With Epidermolysis Bullosa

NCT02014376 ↗

Phase 2 Completed 48 enrolled Scioderm, Inc. Amicus Therapeutics · collab
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study was to assess whether the topical use of SD-101 cream (3% or 6%) was effective in treating wounds in participants with Simplex, Recessive Dystrophic, or Junctional non-Herlitz Epidermolysis Bullosa (EB).

Timeline

Start
2014-01-06
Primary completion
2014-06-24
Completion
2014-06-24

Outcome

Missed primary endpoint

registry analysis (superiority test); SD-101 Dermal Cream (6%) vs Vehicle (0%); p =0.3699; Fisher Exact NCT02014376 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject SD-101 Oligonucleotide (other) 3 % Topical
Subject SD-101 Oligonucleotide (other) 6 % Topical

Indications