A Phase 2 Study on Effect of Thymosin Beta 4 on Wound Healing in Patients With Epidermolysis Bullosa
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|ClinicalTrials.gov 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
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|Condition or disease||Intervention/treatment||Phase|
|Epidermolysis Bullosa||Drug: Thymosin Beta 4 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
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
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 70 days ]
- Number of Participants Whose Wounds Have Healed [ Time Frame: 56 days ]Wound healing means that the wound has closed without any drainage
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.
|Ages Eligible for Study:||2 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.)
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 ClinicalTrials.gov identifier (NCT number): NCT00311766
|Study Director:||David R Crockford||RegeneRx Biopharmaceuticals, Inc.|
|Responsible Party:||RegeneRx Biopharmaceuticals, Inc.|
|Other Study ID Numbers:||
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|
Thymosin Beta 4
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Vesiculobullous