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A Study to Evaluate ENERGI-F703EB Cream in Epidermolysis Bullosa

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
This is a phase II, intra-subject randomized, double-blind, vehicle-controlled, parallel, multicenter study to evaluate the safety and preliminary efficacy of ENERGI-F703EB Cream in subjects who are ≥ 18 years old with epidermolysis bullosa simplex (EBS), junctional epidermolysis bullosa (JEB), or dystrophic epidermolysis bullosa (DEB). In total, approximately 24 subjects will be enrolled from multiple sites in Taiwan. The study duration per subject is approximately 16 weeks; which includes a 2 to 4-week period between Visit 1 and Visit 2 for screening, an 8-week period from Visit 2 to Visit 7 for treatment, and a 4-week period from Visit 7 to Visit 9 for safety follow-up.
Trial Details
NCT Number NCT07858422
Lead Sponsor Energenesis Biomedical Co., Ltd.
Conditions
(from sponsor)		 Epidermolysis Bullosa (EB), Junctional Epidermolysis Bullosa, Epidermolysis Bullosa Simplex, Dystrophic Epidermolysis Bullosa
Related terms Epidermolysis Bullosa, Epidermolysis Bullosa Dystrophica, Epidermolysis Bullosa Simplex, Epidermolysis Bullosa, Junctional
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov