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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00311766
Recruitment Status : Terminated (Lack of patient availability and expiration of study drug)
First Posted : April 6, 2006
Results First Posted : June 10, 2013
Last Update Posted : May 12, 2014
Information provided by (Responsible Party):
RegeneRx Biopharmaceuticals, Inc.

Brief 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).

Condition or disease Intervention/treatment Phase
Epidermolysis Bullosa Drug: Thymosin Beta 4 Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2006
Actual Primary Completion Date : July 2010
Actual Study Completion Date : November 2012

Arm Intervention/treatment
Placebo Comparator: 1
Placebo comparator gel does not contain any active drug. Topical administration of 0.0% Thymosin Beta 4 gel, once a day (qd) up to 56 days
Drug: Placebo
Topical administration, 0.00% Thymosin Beta 4 gel qd up to 56 days

Active Comparator: 2
Topical Administration of 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel once a day (qd) up to 56 days
Drug: Thymosin Beta 4
Topical administration, 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days

Primary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 70 days ]

Secondary Outcome Measures :
  1. Number of Participants Whose Wounds Have Healed [ Time Frame: 56 days ]
    Wound healing means that the wound has closed without any drainage

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00311766

Sponsors and Collaborators
RegeneRx Biopharmaceuticals, Inc.
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Study Director: David R Crockford RegeneRx Biopharmaceuticals, Inc.
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Responsible Party: RegeneRx Biopharmaceuticals, Inc. Identifier: NCT00311766    
Other Study ID Numbers: SSEB
0003031 ( Other Identifier: FDA Office of Orphan Product Development (OOPD) )
First Posted: April 6, 2006    Key Record Dates
Results First Posted: June 10, 2013
Last Update Posted: May 12, 2014
Last Verified: April 2014
Keywords provided by RegeneRx Biopharmaceuticals, Inc.:
Epidermolysis Bullosa
cutaneous wound-healing
chronic wound-healing
Thymosin Beta 4
Additional relevant MeSH terms:
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Epidermolysis Bullosa
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
Skin Diseases, Vesiculobullous