Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
NCT ID:
NCT04173650
Eligibility Criteria:
Inclusion Criteria:
1. Subjects must be 6 months or older at screening.
2. Subjects who have a confirmed diagnosis of DEB based on electron microscopy, immunomapping, or genetic testing. Subjects with severe DEB (e.g., RDEB patients with absent Col VII/no anchoring fibrils) and milder forms of DEB (e.g., RDEB patients with reduced Col VII and/or anchoring fibril levels) are eligible.
3. Presence for at least four weeks of two 10 - 50 cm2 wounds (unroofed EB erosions) at least 4 inches apart that can be considered similar enough in size, wound location and expected healing characteristics to be a matched pair. Neither index wound may have been treated with any local (topical, subcutaneous, etc) or systemic therapeutic other than standard of care treatments described in this protocol (i.e. local or systemic antimicrobials to control infection, topical anesthetic and oral analgesics if required) in the past 3 months prior to screening.
4. Females of childbearing potential must have a negative urine or serum pregnancy test at screening and agree to continue use of an acceptable form of birth control throughout the duration of the study. Acceptable forms of birth control include oral, implant, injectable, and transdermal contraceptives; an intrauterine device; or other forms considered acceptable by the investigator. A female subject is eligible to participate if she is not pregnant, is not a woman or childbearing potential (WOCBP), or is a WOCBP who agrees to follow the contraceptive guidance above.
5. Post-pubertal males who agree to use an acceptable method of contraception for the duration of the study.
6. Subjects 18 years of age and older must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Subjects under the age of 18 years must be capable of giving assent (if age-appropriate), and/or they must have a guardian capable of providing consent.
7. Willing to comply with the protocol requirements.
Note: Reference to Appendix 3 can be located in the protocol
Exclusion Criteria:
1. Concomitant treatment at the time of screening or at any time during the study of either study wound (control or AGLE-102 treated) with local or systemic therapy other than standard of care treatments described in this protocol (i.e. local or systemic antimicrobials to control infection, topical anesthetic and oral analgesics if required). Concomitant treatment of non-study wounds with local therapy during the study is acceptable. Systemic treatment of RDEB wounds (except as noted for standard of care) during the study is not acceptable. Subjects unwilling to abstain from prohibited concomitant treatment of study wounds (treated or control) and/or systemic treatment of RDEB wounds during the study period are excluded.
2. Either study wound located within 6 inches of wounds treated concurrently with any other local therapy.
3. Clinical evidence of systemic infection.
4. History of bone marrow transplantation.
5. Diagnosed clinically significant autoimmune disease
6. Wound that extends across the fingers, toes, pubic or perineum region are excluded from being index wounds.
7. The subject has clinical evidence of an active infection at the wound site.
8. Current malignancy (including skin cancer), a life expectancy of \< 2 years, or severe cardiopulmonary disease that restricts ambulation to the clinical facility.
9. History of coagulopathy.
10. Chronic use of systemic steroids or immunosuppressive agents.
11. Allergy to human albumin, streptomycin, or penicillin.
12. The subject is likely to be a recipient of tissue or organ transplantation.
13. Current history of alcohol or substance abuse or has a history of alcohol or substance abuse that required treatment within the previous 12 months.
14. History of poor compliance or unreliability.
15. Females who are pregnant, nursing, or planning a pregnancy during their participation in the study.
16. Concurrent participation in another investigational drug, biologic or device study that could confound study data.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Study:
NCT04173650
Study Brief:
Protocol Section:
NCT04173650