Trial Information

Summary: Study of the Safety and Efficacy of Thymosin Beta 4 in the Treatment of Patients with Epidermolysis Bullosa (EB)

A double-blind, placebo-controlled study using 3 concentrations of thymosin beta 4 (Tß4) to evaluate its safety and tolerability, when administered topically once daily (qd) for up to 56 days, in patients with epidermolysis bullosa. There will be 3 groups of patients. Each group will include 12 patients requiring treatment for dystrophic EB or junctional EB.

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.
• Male or female, eighteen months of age or older for patients with dystrophic EB or 2 years of age or older for patients with junctional EB.
• Diagnosis of Junctional or Dystrophic EB, confirmed by electron microscopy or immunofluorescence antigenic mapping, when available.
• At least one active, unroofed EB erosion on the limb or trunk
• Lesion size 5 to 50 cm2, inclusive.
• Stable index lesion present for 14-60 days before enrollment.
• No clinically significant abnormalities on screening laboratory tests. 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.)

If you would like to learn more about participating in this study, please send an e-mail message using the form below.