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 @ 4:20 PM
Ignite Modification Date:
2025-12-24 @ 4:20 PM
NCT ID:
NCT00311766
Eligibility Criteria:
Inclusion Criteria:
* Informed Consent form signed by the patient or patient's legal representative; also, if the patient is under the age of majority but capable of providing assent, signed assent from the patient
* Diagnosis of junctional or dystrophic EB.
* Patients who present with Hallopeau-Siemens subtype may be enrolled.
* At least one active, unroofed EB erosion on the limb or on the trunk.
* Lesion size 5 to 50 cm2, inclusive.
* Stable lesion present for 14-60 days before enrollment.
* More that one member in a family can be enrolled as long as that member is treated to a different cohort with an assurance that the study medication will not be shared.
* No clinically significant abnormalities (Grade 2 or higher on the National Cancer Institute \[NCI\] toxicity scale) on Screening laboratory tests, except for the following specific laboratory threshold result: albumin must be 2 g/dL or higher; hemoglobin must be 8 g/dL or higher.
Exclusion Criteria:
* Clinical evidence of local infection of the index (targeted) lesion.
* Use of any investigational drug within the 30 days before enrollment.
* Use of immunotherapy or cytotoxic chemotherapy within the 60 days before enrollment.
* Use of systemic or topical steroidal therapy within the 30 days before enrollment.Inhaled steroids are allowed.
* Use of systemic antibiotics within the 7 days before enrollment.
* Current or former malignancy.
* Arterial or venous disorder resulting in ulcerated wounds.
* Diabetes mellitus.
* Pregnancy or breastfeeding during the study. (A serum pregnancy test will be performed at Screening for female patients of childbearing potential.)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT00311766
Study Brief:
Protocol Section:
NCT00311766