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TB-500

Thymosin Beta-4, TB4, TĪ²4

Quick Stats
Studies 6
Trials 21
Overview Studies Clinical Trials
Completed PHASE2 INTERVENTIONAL NCT00832091

Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

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

Detailed Description

The purpose of this double-blind, placebo-controlled, dose-response study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 (TĪ²4), administered topically, in patients with Venous Stasis (VS) ulcers. VS ulcers develop on the ankle or lower leg in patients with chronic vascular disease. In these patients, blood flow in the lower extremities is impaired, leading to edema (swelling) and mild redness and scaling of the skin that gradually progress to ulceration. TĪ²4 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.

Interventions

Name: Thymosin Beta 4
Type: DRUG
Description: There were 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There were three concentrations of gel used for topical administration to the active groups: 0.01% weight/weight (w/w), 0.03% w/w, and 0.1% w/w thymosin beta 4 gel applied once daily for up to 84 days
Name: Placebo
Type: DRUG
Description: There were 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There was one concentration of placebo gel for topical administration to the placebo group. The concentration was 0.0% weight/weight (w/w) thymosin beta 4 gel applied once daily for up to 84 days

Primary Outcomes

Measure: Safety and Tolerability of Thymosin Beta 4 (TĪ²4) Applied to Patients With Venous Stasis (VS) Ulcers for up to 84 Days
TimeFrame: Up to 84 days
Description: All Treatment-Emergent (TE) Serious Adverse Events (SAEs) and Adverse Events (AEs) by treatment with TĪ²4 gel at the combined 3 doses in the safety population with Venous Stasis (VS) ulcers for up to 84 days. TEAE is defined as a side effect that begins or that worsens in severity after the application of at least one dose of TĪ²4 gel on the venous stasis ulcer. A pre-existing condition is not considered an AE, but if it worsens during the study, then it may be considered an AE

Trial Information

NCT ID

NCT00832091

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

RegeneRx Biopharmaceuticals, Inc.

Last Updated

December 15, 2025