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

NCT03578029 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2022-08-22

No results posted yet for this study

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).

Conditions

  • Junctional Epidermolysis Bullosa
  • Dystrophic Epidermolysis Bullosa

Interventions

DRUG

RGN-137

It will be applied topically to the appropriate wound once a day for up to 84 days.

DRUG

Placebo

It will be applied topically to the appropriate wound once a day for up to 84 days.

Sponsors & Collaborators

  • Lenus Therapeutics, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-22
Primary Completion
2021-09-01
Completion
2021-11-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03578029 on ClinicalTrials.gov