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Evaluation of the Safety and Efficacy Study of RGN-137 Topical Gel for Junctional and Dystrophic Epidermolysis Bullosa | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

A Randomized,Single-Blind, Placebo-controlled, Self-matched Pairing, Independent Evaluated Study to Evaluate the Efficacy and Safety of RGN-137 Topical Gel in Subjects With Junctional and Dystrophic Epidermolysis Bullosa (CELEB)

NCT03578029•Lenus Therapeutics, LLC

View on ClinicalTrials.gov

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).

Detailed 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 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.

Eligibility

Age

4 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female and at least 4 years old with a diagnosis of DEB or JEB
•Patients and their parents or guardians must be willing and able to provide written informed consent/assent
•Presence of 1 pair of stable index wounds within the specified size range at study
•1. Index wounds must have a surface area between 5 cm2 and 50 cm2, inclusive at the screening visit
•2. The index wounds selected as pairing must be relatively matched in terms of size and location
•Women of childbearing potential must have a negative pregnancy test prior to randomization
•Sexually active subjects must agree to use medically accepted methods of contraception during the study

Exclusion Criteria

•Have any clinical evidence of local infection of the index lesion
•Use of prior or concomitant medication (Any investigational drug within 30 days, Immunotherapy or cytotoxic chemotherapy within 60 days, Systemic steroidal therapy within 30 days, and topical steroidal therapy within 14 days)
•History of sensitivity to any component of the treatment
•Neurological, cardiovascular, respiratory, hepatic, renal, or metabolic disease likely to interfere with the subject's participation in or completion of the study (At the discretion of investigator, participants with cardiomyopathy can participate)
•Current or former malignancy, including a history of squamous cell carcinomas
•Arterial or venous disorder resulting in ulcerated wounds
•Uncontrolled diabetes mellitus
•Pregnancy or breastfeeding during the study
•Girls or women who have had menarche but have not completed menopause
•Any condition or situation likely to cause the subject to be unable or unwilling to participate in the study procedures

Locations (5)

Northwestern University

Evanston, Illinois, United States

SUNY Downstate Medical Center

Brooklyn, New York, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Texas Dermatology and Laser Specialists

San Antonio, Texas, United States

Key Dates

Start Date

May 22, 2019

Primary Completion Date

September 1, 2021

Completion Date

November 23, 2021

Last Updated

August 22, 2022

Enrollment

ACTUAL participants

Conditions

Junctional Epidermolysis BullosaDystrophic Epidermolysis Bullosa

Interventions

RGN-137

DRUG

Placebo

DRUG

Study to Evaluate Safety and Efficacy of ALLO-ASC-SHEET in Subjects With Dystrophic Epidermolysis Bullosa

NCT05157958

Dystrophic Epidermolysis Bullosa

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RECRUITINGPHASE1/PHASE2

Gentamicin for Junctional Epidermolysis Bullosa

NCT03526159

Junctional Epidermolysis Bullosa

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ACTIVE_NOT_RECRUITINGPHASE3

A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa

NCT04213261

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 22, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Study to Evaluate Safety and Efficacy of ALLO-ASC-SHEET in Subjects With Dystrophic Epidermolysis Bullosa

Gentamicin for Junctional Epidermolysis Bullosa

A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa

Evaluation of D-Fi for the Treatment of Wounds Due to DEB

Pilot Study of ELK-003 Eye Drops for Treating Ocular Manifestations of Epidermolysis Bullosa

A Phase 3b Study for the Treatment of Dystrophic Epidermolysis Bullosa (DEB) in New and Previously EB-101 Treated Patients