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:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
NCT ID:
NCT01528306
Eligibility Criteria:
Inclusion Criteria:
* Written consent must be obtained from a parent or legally authorized representative. Assent will be obtained according to local requirements.
* Subjects with a clinical diagnosis of DEB with recurring blisters, ≥ 2 years of age at Screening. Subjects may be of either sex and of any race or skin type provided that their skin color, in the opinion of the Investigator, will not interfere with the study assessments.
* A parent or legally authorized representative must be willing and able to ensure subject is present for all required study visits.
* A parent or legally authorized representative must be able to follow instructions.
* Have an open wound for ≤ 72 hours that:
* is still open and has not scabbed or crusted over
* has no dermatologic disease and/or condition in the treatment area (other than DEB with recurring blisters), including active or recent infection (within 7 days) that may be exacerbated by treatment, require treatment with antibiotics / antifungals /antivirals, require a surgical intervention, or cause difficulty with examination
* is ≥ 4 cm² and ≤ 48 cm2 in total area (open portion)
* Females of childbearing potential (defined as post-menarcheal as documented in the medical history) may participate in the study if they meet all of the following conditions:
* they are not breast feeding;
* they have a negative urine pregnancy test at Week 1 Period 1;
* they agree to undertake scheduled urine pregnancy tests at Week 1 for Periods 1, 2, \& 3 and at study exit
* they do not intend to become pregnant during the study;
* they are using adequate birth control methods and they agree to continue using those methods for the duration of the study
* A parent or legally authorized representative must be willing and able to ensure subject is present for all required study visits (for minor subjects)
* A parent or legally authorized representative must be able to follow instructions (for minor subjects)
Exclusion Criteria:
* Contraindications or hypersensitivity to the use of the test article, their components (e.g., aprotinin, fibrinogen), or substances used in the manufacture of the test article (e.g., penicillin, streptomycin, amphotericin B, bovine serum albumin).
* Therapy with another investigational agent within thirty (30) days of the Screening Visit, or during the study.
* Have uncontrolled intercurrent or chronic illness that, in the opinion of the Investigator, would limit compliance with study requirements, represents a potential safety risk, or require treatment with an excluded drug/treatment.
* The Investigator or Medical Monitor may declare any subject ineligible for a valid medical reason.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT01528306
Study Brief:
Protocol Section:
NCT01528306