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

2018-07-12 09:43:11 | BioPortfolio

Summary

The objective of this study is to compare the efficacy and safety of RGN-137 topical gel with that of placebo gel for treatment of junctional epidermolysis bullosa (JEB) or dystrophic epidermolysis bullosa (DEB).

Description

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 or 2 sets of matched-pair wounds. The investigator will assign pairs 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 evaluators will be blinded to the treatment assignments for each lesion.

Study Design

Conditions

Junctional Epidermolysis Bullosa

Intervention

RGN-137, Placebo

Status

Not yet recruiting

Source

GtreeBNT Co., Ltd.

Results (where available)

View Results

Links

Published on BioPortfolio: 2018-07-12T09:43:11-0400

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