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A Phase 2 Study on Effect of Thymosin Beta 4 on Wound Healing in Patients With Epidermolysis Bullosa

NCT00311766 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-05-12

Study results available
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Summary

The purpose of this study is to investigate a treatment to enhance the healing of acute and chronic nonhealing cutaneous wounds, such as the erosions experienced by patients with Epidermolysis Bullosa (EB), by the known activity of thymosin beta 4 (Tβ4). Funding Source - FDA Office of Orphan Product Development (OOPD).

Conditions

  • Epidermolysis Bullosa

Interventions

DRUG

Thymosin Beta 4

Topical administration, 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days

DRUG

Placebo

Topical administration, 0.00% Thymosin Beta 4 gel qd up to 56 days

Sponsors & Collaborators

  • RegeneRx Biopharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • David R Crockford · RegeneRx Biopharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2010-07-31
Completion
2012-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00311766 on ClinicalTrials.gov