NCT07858422 A Study to Evaluate ENERGI-F703EB Cream in Epidermolysis Bullosa

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 24 participants in total. It began in 2026-10-08 with a primary completion date of 2027-03-15.

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: A subject is eligible for the study if all of the following apply: 1. With either gender aged ≥ 18 years old at the Screening Visit. 2. Subject has clinical diagnosis and laboratory evidence of EB simplex, junctional EB, or dystrophic EB. Note: Subjects may be included if diagnostic testing confirms subtype. Acceptable diagnostic testing methods include transmission electron microscopy and immunofluorescence studies. 3. 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. 4. Potential target lesions have been present for ≥ 21 days and \< 9 months at the Screening Visit (Visit 1). 5. Subject's target EB lesions in the matched target lesion pair fulfill all of the following criteria at the Baseline Visit (Visit 2): 1. The size of each lesion is between 10 - 40 cm2. 2. Each lesion did not exhibit ≥ 30% reduction in size compared to the measurement taken at the Screening Visit. 3. The two lesions have a size difference of ≤ 20%. 4. The two lesions are separated by ≥ 6 cm apart from each other. 6. Subject is able and willing to follow study procedures and instructions. 7. Subject has signed the written informed consent form. 8. Male subjects must be surgically sterile or commit to the use of a highly effective method of contraception (See Appendix 1) for the duration of the study. 9. Female subjects are eligible only if all of the following apply: 1. Not pregnant with a negative serum or urine pregnancy test at the Screening Visit and at Visit 2 before randomization (test not required for females of non-childbearing potential). 2. Not lactating. 3. Not planning to become pregnant during the study. 4. If of childbearing potential, commits to the use of a highly effective method of contraception for the duration of the study (See Appendix 1 for acceptable methods of contraception). Exclusion Criteria: A subject meeting any of the exclusion criteria will be excluded from study participation: 1. Subject's target EB lesions in the matched target lesion pair fulfill any of the following criteria: 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. 2. Use of topical steroidal therapy within 28 days prior to Visit 2. 3. Use of topical silver products (e.g. silver sulfadiazine cream, colloidal silver) within 14 days prior to Visit 2. 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). 3. Subject has a current or history of malignancy within 2 years prior to Visit 2. 4. Use of any other investigational drug within 28 days prior to the Screening Visit. 5. With known or suspected hypersensitivity to any ingredients in ENERGI-F703EB Cream or matched vehicle cream. 6. With any of the following impaired hepatic or renal functions at the Screening Visit: 1. ALT or AST \> 2× ULN 2. Total bilirubin \> 1.5× ULN 3. eGFR \< 30 mL/min/1.73 m2 Note: For eGFR, the CKD-EPI creatinine equation (2021) will be used: eGFR (mL/min/1.73 m2) = 142 × min (SCr/K, 1)α × max (SCr/K, 1)-1.200 × 0.9938age × (1.012 if female); where: * SCr = serum creatinine (mg/dL) * K = 0.7 (females) or 0.9 (males) * α = -0.241 (females) or -0.302 (males) * min = indicates minimum of SCr/K or 1 * max = indicates maximum of SCr /K or 1 7. With any condition judged by the investigator that entering the trial may be detrimental to the subject.

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