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.
With either gender aged ≥ 18 years old at the Screening Visit.
Subject has clinical diagnosis and laboratory evidence of EB simplex, junctional EB, or dystrophic EB.
Potential target and target lesions can be located anywhere on the body except on or near the joints (e.g., the elbows and the ankle), face, scalp, groin, palms and soles.
Potential target lesions have been present for ≥ 21 days and < 9 months at the Screening Visit (Visit 1).
Have clinical signs of infection as evidenced by ongoing adverse event and/or use of topical antibiotics within 14 days prior to Visit 2.
Use of topical steroidal therapy within 28 days prior to Visit 2.
Use of topical silver products (e.g. silver sulfadiazine cream, colloidal silver) within 14 days prior to Visit 2.
Use of systemic steroidal therapy within 28 days prior to Visit 2 (Except for inhaled, ophthalmic, or for systemic manifestations of EB per investigator's discretion).
Parallel
ENERGI-F703EB Cream
DrugStandard of care and ENERGI-F703EB Cream is applied for the treatment of Epidermolysis Bullosa
Matched vehicle cream
DrugStandard of care and matched vehicle cream is applied for the treatment of Epidermolysis Bullosa
Incidence of Local Target Lesion Adverse Events
Number of local target lesion adverse events with onset during the specified assessment period.
Incidence of Adverse Events Excluding Local Target Lesion Adverse Events
Number of adverse events, excluding local target lesion adverse events, with onset during the specified assessment period.
Number of participants with abnormalities in vital signs
Vital signs measurement consist of systolic and diastolic blood pressure, respiratory rate, pulse rate, and body temperature.
Number of participants with abnormalities in laboratory examination results
Laboratory tests to be measured in this study will consist of the following: * Hematology: white blood cell (WBC), neutrophils, lymphocytes, monocytes, eosinophils, basophils, hemoglobin, hematocrit, platelets, red blood cells (RBC). * Biochemistry: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), total bilirubin, direct bilirubin, glucose, HbA1c, serum creatinine, blood urea nitrogen (BUN), albumin, prealbumin, and estimated glomerular filtration rate (eGFR). * Urinalysis: chemical strip (specific gravity, pH, occult blood, leukocytes, glucose, protein, ketones, bilirubin.
Number of Subjects With Abnormal Physical Examination Findings
Number of subjects with abnormal physical examination findings at Day 57 and Day 85.
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