Phase 2
N=8
Study of Alwextin® Cream in Treating Epidermolysis Bullosa
Epidermolysis Bullosa
Bottom Line
View on ClinicalTrials.gov: NCT00825565 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcome: Primary: Blister/Erosion Reduction Based on Change in Body Surface Area (BSA) Coverage — 57.25; 39.40; 27.25; 25.45 percentage of BSA involvement
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Alwextin cream (Drug)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blister/Erosion Reduction Based on Change in Body Surface Area (BSA) Coverage |
57.25; 39.40; 27.25; 25.45 | — |
| PRIMARY Target Wound Size Reduction or Closure |
8; 1 | — |
| PRIMARY Physician Global Assessment of Severity (PGAS) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Physician Assessment of Individual Signs |
1; 0; 0; 0; 4; 4 | — |
Summary
The purpose of this study is to determine how safe and effective allantoin 3% cream (Alwextin) is in improving the healing of recurrent skin lesions and reducing overall blistering in people with epidermolysis bullosa (EB). Allantoin 3% cream is applied topically to the entire body once daily.
Eligibility Criteria
Inclusion Criteria
- history of epidermolysis bullosa
Exclusion Criteria
- use of any skin product containing allantoin for 30 days prior to enrollment
Data sourced from ClinicalTrials.gov (NCT00825565). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.