Trial · Interventional
TerminatedPhase 2Registry dataEvaluation of the Safety and Efficacy Study of RGN-137 Topical Gel for Junctional and Dystrophic Epidermolysis Bullosa
Short name CELEB
This trial was stopped early.
Reason given at the registry: Business Decision
Overview
- Status
- Terminated
- Phase
- Phase 2
- Enrollment
- 4 participants (actual)
- Sponsor
- Lenus Therapeutics, LLC · Industry
- Design
- Randomized · Triple masking
- Countries
1 country
United States
- Start
- 22 May 2019
- Primary completion
- 1 Sept 2021
- Completion
- 23 Nov 2021
- First posted
- 5 Jul 2018
- Last update posted
- 22 Aug 2022
- Conditions
- Junctional Epidermolysis Bullosa · Dystrophic Epidermolysis Bullosa
Timeline
1 trial · 1 stopped early
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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).
Interventions
- RGN-137Drug
- PlaceboDrug
Arms2
Experimental
RGN-137
It is formulated as a gel for topical administration.
Placebo comparator
Placebo
It is composed of the same excipients as RGN-137 formulation without the active ingredient.
Primary outcomes1
Outcomes the sponsor listed as primary.
Time to achieving 50% reduction in area of each index wound from Day 1 up to Day 84.
Time frame · up to Day 84
Registry description
This primary endpoint will the time to achieving 50% reduction in area of each index wound from Day 1 up to Day 84, defined as date of the first study visit on which 50% reduction in index wound area is achieved minus date of Day 1 visit.
Secondary outcomes(3)
Time to achieving 50%, 75%, and 100% (with drainage or without drainage) reduction in area of each index wound from Day 1 up to Day 84.
Time frame · up to Day 84
Registry description
This secondary endpoint will the time to achieving 50%, 75%, and 100% reduction in area of each index wound from Day 1 up to Day 84, defined as date of the first study visit on which 50% reduction in index wound area is achieved minus date of Day 1 visit.
Incidence of 50%, 75%, and 100% reduction and complete re-epithelialization without drainage in area of each index wound at the scheduled visits.
Time frame · up to Day 84
Registry description
This secondary endpoint will be summarized by treatment using frequency counts and percentages.
Change from Baseline and percent change from Baseline in surface area of each index wound at the scheduled visits.
Time frame · up to Day 84
Registry description
This secondary endpoint will be computed for each treatment group as well as for treatment difference at each visit.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 4 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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