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Am I Eligible?
Eligibility:
Ages Eligible for Study: 2 years of age or older
Genders Eligible for Study: Both
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.
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.
- Clinically significant abnormalities on Screening laboratory tests, except for the following specific laboratory threshold result:
- - albumin <2.0 g/dL.
- - hemoglobin < 8 g/dL
- Use of systemic or topical steroidal therapy within the 30 days before enrollment. (except inhaled steroids)
- 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.)
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