Clinical Trials Logo

Clinical Trial 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).


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03578029
Study type Interventional
Source Lenus Therapeutics, LLC
Contact
Status Terminated
Phase Phase 2
Start date May 22, 2019
Completion date November 23, 2021

See also
  Status Clinical Trial Phase
Completed NCT03536143 - A Phase I/II Study of KB103, a Topical HSV1-COL7, on DEB Patients Phase 1/Phase 2
Recruiting NCT04917887 - Long-Term Follow-up Protocol
Completed NCT04917874 - A Long-term Treatment With B-VEC for Dystrophic Epidermolysis Bullosa Phase 3
Completed NCT03472287 - To Evaluate the Pharmacokinetic of Diacerein and Rhein After Maximum Use in Patients With Epidermolysis Bullosa (EB) Phase 1
Recruiting NCT05157958 - Study to Evaluate Safety and Efficacy of ALLO-ASC-SHEET in Subjects With Dystrophic Epidermolysis Bullosa Phase 2
Withdrawn NCT01528306 - A Pilot Study of HP802-247 in Dystrophic Epidermolysis Bullosa Phase 2
Completed NCT02178969 - Short Term Observational Study in DEB Patients
Withdrawn NCT04214002 - The Natural History of Wounds in Patients With Dystrophic Epidermolysis Bullosa (DEB)
Recruiting NCT04757727 - Gynecological Follow-up of Patients With Dystrophic Epidermolysis Bullosa (EBD)
Withdrawn NCT01768026 - Prospective, Longitudinal Natural History Study in Dystrophic Epidermolysis Bullosa N/A
Completed NCT01538862 - Efficacy of Granulocyte Colony Stimulating Factor (GCSF) In Patients With Dystrophic Epidermolysis Bullosa N/A
Completed NCT03183934 - A Follow-up Study to Evaluate the Efficacy and Safety of ALLO-ASC-DFU in ALLO-ASC-EB-101 Clinical Trial
Completed NCT02579369 - Study to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Dystrophic Epidermolysis Bullosa Phase 1/Phase 2
Withdrawn NCT02004600 - Pilot Study Evaluating the Efficiency and the Tolerance of the PDT in the Treatment of Epidermal Dysplasia for Patients Affected by Hereditary DEB N/A
Completed NCT04491604 - Ph 3 Efficacy and Safety of B-VEC for the Treatment of DEB Phase 3
Not yet recruiting NCT05529134 - Study of PTW-002 in Patients With Dominant or Recessive Dystrophic Epidermolysis Bullosa Due to Mutation(s) in Exon 73 of the COL7A1 Gene Phase 1/Phase 2
Not yet recruiting NCT04173650 - MSC EVs in Dystrophic Epidermolysis Bullosa Phase 1/Phase 2