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:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT04613102
Eligibility Criteria:
Inclusion Criteria:(phase 2) Patients 4-50 years of age
* Diagnosis of RDEB (clinically and/or molecular diagnosis)-
* Wounds that have not been healing for over 4 weeks
* Signed consent/assent form Inclusion criteria -Phase 3
* Patients 4-50 years of age
* Diagnosis of EB (clinically and/or molecular diagnosis)
* Evidence of either acute or chronic wounds on both extremities
* Patients enrolled in phase II are also eligible for participation in this phase, if they meet the current criteria and are interested in participation \* Signed consent/assent form
Exclusion Criteria:
* Previous known allergy or intolerance to CBD cream
* Topical and systemic use of cannabinoids in the past 2 weeks
* Topical use of antibiotics, corticosteroids for the past 2 weeks
* Other systemic medications that will interfere with the wound healing (corticosteroids, immunosuppressives, antibiotics) in the past 4 weeks
* Surgery of the selected area in the past 8 weeks
* Patients received medications metabolized via CYP3A4 enzyme (ketoconazole, itraconazole, ritonavir, clarithromycin, phenobarbital, rifampicin, carbamazepine, hexobarbital) for the past 2 weeks
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
50 Years
Study:
NCT04613102
Study Brief:
Protocol Section:
NCT04613102