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Thymosin Beta 4 in Epidermolysis Bullosa
NCT00311766Phase 2
Key facts
- Status
- Terminated
- Start
- Feb 2006
- Primary completion
- Jul 2010
- Modality
- Peptides, Recombinant Proteins and Enzymes
- Drugs
- thymosin beta-4
- Conditions
- epidermolysis bullosa (EB)
01
Overview
Phase 2, randomised, double-blind trial in epidermolysis bullosa (EB) comparing Placebo with Thymosin Beta 4 (2 arms). Primary endpoint: Number of Participants With Adverse Events and Serious Adverse Events at 70 days. Started Feb 2006; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Placebo
Placebo gel (0.0% Tβ4)
Thymosin Beta 4
Active gel (0.01%, 0.03%, or 0.1% Tβ4)
03
Who it enrols
Patients with junctional or dystrophic EB (including Hallopeau-Siemens) with at least one active unroofed erosion (5-50 cm2) stable for 14-60 days.
04
Endpoints
Primary
Number of Participants With Adverse Events and Serious Adverse Events
Secondary
Number of Participants Whose Wounds Have Healed
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