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Effect of Thymosin Beta 4 on Wound Healing in Patients With Epidermolysis Bullosa

Information source: RegeneRx Biopharmaceuticals, Inc.
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epidermolysis Bullosa

Intervention: Thymosin Beta 4 (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: RegeneRx Biopharmaceuticals, Inc.

Official(s) and/or principal investigator(s):
David R Crockford, Study Director, Affiliation: RegeneRx Biopharmaceuticals, Inc.

Overall contact:
David R Crockford, Phone: 301-280-1992, Ext: 109, Email: dcrockford@regenerx.com


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).

Clinical Details

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

Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: To evaluate the safety and tolerability of Tβ4 administered topically once daily

Secondary outcome: To evaluate the lesion healing effectiveness of Tβ4 administered topically qd

Detailed description: EB is a group of genetic diseases characterized by skin-blistering and lesion-formation after minor trauma to the skin. This family of disorders, most of which are inherited, range in severity from mild to the severely disabling and life-threatening. 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.


Minimum age: 2 Years. Maximum age: N/A. Gender(s): Both.


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

- Diagnosis of junctional or dystrophic EB.

- Patients who present with Hallopeau-Siemens subtype may be enrolled.

- At least one active, unroofed EB erosion on the limb or on the trunk.

- Lesion size 5 to 50 cm2, inclusive.

- Stable lesion present for 14-60 days before enrollment.

- More that one member in a family can be enrolled as long as that member is treated to

a different cohort with an assurance that the study medication will not be shared.

- No clinically significant abnormalities (Grade 2 or higher on the National Cancer

Institute [NCI] toxicity scale) on Screening laboratory tests, except for the following specific laboratory threshold result: albumin must be 2 g/dL or higher; hemoglobin must be 8 g/dL or higher.

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.)

Locations and Contacts

David R Crockford, Phone: 301-280-1992, Ext: 109, Email: dcrockford@regenerx.com

UAB Department of Dermatology-The Kirklin Clinic, Birmingham, Alabama 35233, United States; Recruiting
Laura Bradford, Phone: 205-502-9960, Email: lbradford@uabmc.edu
Amy Theos, MD, Principal Investigator

Children's Hospital San Diego & University of California San Diego, San Diego, California 92123, United States; Recruiting

Stanford University School of Medicine, Stanford, California 94305, United States; Recruiting

University of Miami, Miami, Florida 33136, United States; Recruiting

Northwestern University Feinberg School of Medicine Dept of Dermatology, Chicago, Illinois 60614, United States; Recruiting
Anne M Mahoney, MD, Phone: 773-327-3326, Email: amahoney@childrensmemorial.org
AnnCameron Haley, Email: a-haley@northwestern.edu
Amy Paller, MD, Principal Investigator

University of Massachusetts Memorial Health Care, Division of Dermatology, Worcester, Massachusetts 01605-2192, United States; Recruiting
Irene Hill, RN, Phone: 508-856-2908
Karen Wiss, MD, Principal Investigator

Washington University, Dermatology Clinical Trials Unit, St Louis, Missouri 63110, United States; Recruiting

Columbia University Medical Center, New York, New York 10032, United States; Recruiting

University of Rochester, Rochester, New York 14610, United States; Recruiting

St Vincent's Hospital Wound Clinic, Erie, Pennsylvania 16544, United States; Recruiting
Sharon McConnell, Phone: 814-452-7878, Email: smmconnell@healingwounds.com
Thomas Serena, MD, Principal Investigator

Vanderbilt University Medical Center, Nashville, Tennessee 37203, United States; Recruiting

Virginia Clinical Research, Inc., Norfolk, Virginia 23507, United States; Recruiting
Danielle Benedict, Phone: 757-625-0151, Email: dbenedict@vcrinc.org
David Pariser, MD, Principal Investigator

Additional Information

Starting date: January 2005
Last updated: July 13, 2010

Page last updated: October 04, 2010

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