A Phase 2 Study on Effect of Thymosin Beta 4 on Wound Healing in Patients With Epidermolysis Bullosa
Epidermolysis Bullosa
About this trial
This is an interventional treatment trial for Epidermolysis Bullosa focused on measuring Epidermolysis Bullosa, cutaneous wound-healing, chronic wound-healing, Thymosin Beta 4, laminin-5
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.)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
1
2
Placebo comparator gel does not contain any active drug. Topical administration of 0.0% Thymosin Beta 4 gel, once a day (qd) up to 56 days
Topical Administration of 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel once a day (qd) up to 56 days