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Epidermolysis Bullosa (EB)Phase 2NCT07858422

A Study to Evaluate ENERGI-F703EB Cream in Epidermolysis Bullosa

A Phase 2 study testing ENERGI-F703EB Cream in people with Epidermolysis Bullosa (EB) and Junctional Epidermolysis Bullosa, run by Energenesis Biomedical Co., Ltd. at 1 site in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ENERGI-F703EB Cream
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteTaiwan
Study dates
8 Oct 2026to 15 Jun 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A subject is eligible for the study if all of the following apply:
  • 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.
  • Note: Subjects may be included if diagnostic testing confirms subtype. Acceptable diagnostic testing methods include transmission electron microscopy and immunofluorescence studies.
  • 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).
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  • Subject's target EB lesions in the matched target lesion pair fulfill all of the following criteria at the Baseline Visit (Visit 2):
  • The size of each lesion is between 10 - 40 cm2.
  • Each lesion did not exhibit ≥ 30% reduction in size compared to the measurement taken at the Screening Visit.
  • The two lesions have a size difference of ≤ 20%.
  • The two lesions are separated by ≥ 6 cm apart from each other.
  • Subject is able and willing to follow study procedures and instructions.
  • Subject has signed the written informed consent form.
  • 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.
  • Female subjects are eligible only if all of the following apply:
  • 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).
  • Not lactating.
  • Not planning to become pregnant during the study.
  • 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).

Who cannot join

  • A subject meeting any of the exclusion criteria will be excluded from study participation:
  • Subject's target EB lesions in the matched target lesion pair fulfill any of the following criteria:
  • 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).
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  • Subject has a current or history of malignancy within 2 years prior to Visit 2.
  • Use of any other investigational drug within 28 days prior to the Screening Visit.
  • With known or suspected hypersensitivity to any ingredients in ENERGI-F703EB Cream or matched vehicle cream.
  • With any of the following impaired hepatic or renal functions at the Screening Visit:
  • ALT or AST > 2× ULN
  • Total bilirubin > 1.5× ULN
  • 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
  • With any condition judged by the investigator that entering the trial may be detrimental to the subject.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yifang Cheng, PhD contact

+886-2-26270835

ct@energenesis-biomedical.com

Taiwan1 site, 1 recruiting

  • National Cheng Kung University Hospital

    Tainan, 704

    Hsu, Dr.

    Recruiting

Other trials in Taiwan

About this study

Official title: A Phase II Study Evaluating the Safety and Efficacy of ENERGI-F703EB Cream in Subjects With Epidermolysis Bullosa

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.

Being tested
ENERGI-F703EB Cream, Matched vehicle cream
Keywords
Epidermolysis Bullosa, EB
Medical subject headings
Epidermolysis Bullosa, Epidermolysis Bullosa, Junctional, Epidermolysis Bullosa Simplex, Epidermolysis Bullosa Dystrophica

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ENERGI-F703EB CreamDrug

    Standard of care and ENERGI-F703EB Cream is applied for the treatment of Epidermolysis Bullosa

  • Matched vehicle creamDrug

    Standard of care and matched vehicle cream is applied for the treatment of Epidermolysis Bullosa

Study groups in NCT07858422
Study groupRoleWhat they receive
ENERGI-F703EB CreamActive comparatorNot described
Receives: Drug: ENERGI-F703EB Cream
Matched vehicle creamPlacebo comparatorNot described
Receives: Drug: Matched vehicle cream

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Local Target Lesion Adverse Events

    Number of local target lesion adverse events with onset during the specified assessment period.

    Measured: Day 1 through Day 85

Secondary outcomes (12)

  1. 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.

    Measured: Day 1 through Day 85

  2. 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.

    Measured: Baseline to Days 15, 29, 43, 57, 71, and 85

  3. 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.

    Measured: Baseline to Days 57 and 85

  4. Number of Subjects With Abnormal Physical Examination Findings

    Number of subjects with abnormal physical examination findings at Day 57 and Day 85.

    Measured: Day 57 and Day 85

  5. Proportion of Target Lesions With Complete Lesion Closure

    Proportion of target lesions with complete lesion closure as assessed by the investigator at each specified visit.

    Measured: Days 15, 29, 43, and 57

  6. Intra-Subject Comparison of Target Lesion Re-epithelialization

    Intra-subject comparison of target lesions with respect to re-epithelialization as assessed by the investigator at each specified visit.

    Measured: Days 15, 29, 43, and 57

  7. Net Change From Baseline in Target Lesion Size

    Net change in target lesion size from baseline at each specified visit.

    Measured: Baseline to Days 15, 29, 43, and 57

  8. Percent Change From Baseline in Target Lesion Size

    Percent change in target lesion size from baseline at each specified visit.

    Measured: Baseline to Days 15, 29, 43, and 57

  9. Time to First Target Lesion Closure

    Time from baseline to the first occurrence of target lesion closure.

    Measured: Baseline through Day 57

  10. Proportion of Target Lesions With at Least 50% Lesion Closure

    Proportion of target lesions achieving at least 50% lesion closure at each specified visit.

    Measured: Days 15, 29, 43, and 57

  11. Proportion of Target Lesions With at Least 75% Lesion Closure

    Proportion of target lesions achieving at least 75% lesion closure at each specified visit.

    Measured: Days 15, 29, 43, and 57

  12. Proportion of Target Lesions With at Least One Complete Lesion Closure

    Proportion of target lesions that achieved complete lesion closure at least once, as assessed by the investigator, at any assessment up to Visit 7, regardless of subsequent reopening.

    Measured: Baseline through Day 57

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2026
  2. Study start8 Oct 2026 (estimated)
  3. Primary completion15 Mar 2027 (estimated)
  4. Study completion15 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07858422
Sponsor's protocol ID
ENERGI-F703EB-01
Status last verified
Oct 2026
First submitted
20 Aug 2026
Last updated
5 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ENERGI-F703EB Cream in people with Epidermolysis Bullosa (EB) and Junctional Epidermolysis Bullosa, run by Energenesis Biomedical Co., Ltd. at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yifang Cheng, PhD (+886-2-26270835, ct@energenesis-biomedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Local Target Lesion Adverse Events (time frame: Day 1 through Day 85). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07858422.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.

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