Status:
TERMINATED
A Phase 2 Study on Effect of Thymosin Beta 4 on Wound Healing in Patients With Epidermolysis Bullosa
Lead Sponsor:
RegeneRx Biopharmaceuticals, Inc.
Conditions:
Epidermolysis Bullosa
Eligibility:
All Genders
2+ years
Phase:
PHASE2
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...
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 mi...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00311766
Start Date
February 1 2006
End Date
November 1 2012
Last Update
May 12 2014
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.