NCT00382174

Study of Thymosin Beta 4 in Patients With Pressure Ulcers

A Randomized, Double-Blind, Placebo-Controlled, Dose Response Study of the Safety and Efficacy of Thymosin Beta 4 in the Treatment of Patients With Pressure Ulcers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: RegeneRx Biopharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 administered topically in patients with Pressure Ulcers

Detailed description

The purpose of this double-blind, placebo-controlled, dose-escalation study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 (Tβ4), administered topically, in patients with Pressure Ulcers (PU). PU is caused by prolonged pressure or rubbing of the body in areas prone to moisture and friction. PU affects primarily elderly, bedridden patients. 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.

Conditions

• Pressure Ulcers

Interventions

Type	Name	Description
DRUG	Placebo	Topical administration of 0.00% thymosin beta 4 qd up to 84 days
DRUG	Thymosin Beta 4	Topical Administration of 0.01, 0.02, and 0.1% thymosin beta 4 gel qd for up to 84 days

Timeline

• Start date: 2006-05-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2006-09-28
• Last updated: 2010-02-01
• Results posted: 2010-02-01

Locations

12 sites across 1 country: United States