Evaluation of the Safety and Efficacy Study of RGN-137 Topical Gel for Junctional and Dystrophic Epidermolysis Bullosa

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2019
RGN‐137 will be evaluated for efficacy and safety compared to a Placebo. A matched‐pair design will be used to evaluate RGN‐137 treatment versus placebo for treatment of 15 subjects with JEB or DEB. Eligible subject must have 1 set of matched‐pair wound. The investigator will assign pair of index wounds, each wound with an area between 5cm2 and 50cm2, inclusive, for the eligible subject on Day 1, and for each pair, one wound will be randomized to receive RGN‐137 gel and the other to receive Placebo gel. Subjects and independent evaluator will be blinded to the treatment assignments for each wound.
Epistemonikos ID: 45eee3d0fbc0b5730e803a22a9149a4b05e8164c
First added on: May 21, 2024