Official Title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Study of the Safety and Efficacy of Thymosin Beta 4 in the Treatment of Patients with Epidermolysis Bullosa

Purpose: The purpose of this study is to investigate a treatment to enhance healing of acute and chronic nonhealing cutaneous wounds, such as lesions associated with Epidermolysis Bullosa (EB), by the known activity of Thymosin Beta 4 (Tβ4). Tβ4 is a synthetically-produced copy of a naturally-occurring 43 amino acid peptide that has wound healing and anti-inflammatory properties and can up-regulate the expression of laminin-5.

Study Type: Phase 2, Interventional

Study Design: Randomized, double-blind, placebo-controlled, dose-escalation study

Location: U.S., 13 to 15 sites

Expected Total Enrollment: 36

Targeted Study Completion: 2009

Study Start: Recruiting

ClinicalTrials.gov ID: NCT00311766

Objectives:

• To evaluate the safety and tolerability of Thymosin Beta 4 (Tβ4), administered topically once daily (qd) for up to 56 days, in patients with epidermolysis bullosa.

• To evaluate the lesion healing effectiveness of Tβ4, administered topically qd for up to 56 days, in patients with epidermolysis bullosa.