Efalizumab in the Treatment of Alopecia, Phase II
Determine the effect that treatment with efalizumab has on scalp hair re-growth in younger adults affected by severe variants of alopecia areata, including alopecia totalis, alopecia universalis, and severe ophiasis variants.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Efalizumab in the Treatment of Alopecia Totalis/Universalis in Young Adults, Phase II|
- Percentage re-growth of scalp hair loss [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Self-assessment (SA) and Static physician global assessment (SPGA) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Body hair re-growth at 48 weeks [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Quality of life questionnaire [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||August 2008|
|Estimated Study Completion Date:||July 2009|
|Estimated Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Subjects receiving drug
1 mg/kg subcutaneously once weekly for 48 weeks, following an initial conditioning dose of 0.7 mg/kg at week 0.
Other Name: Raptiva
This is a Phase II trial (single-center, open-label, prospective study) where subjects with severe forms of alopecia areata, namely alopecia totalis, universalis, and severe ophiasis, will be treated with efalizumab (Raptiva), a humanized monoclonal anti-CD11a antibody that reversibly inhibits T cell activation and migration, weekly for 48 weeks. We will assess for effect on hair and body re-growth as well as record any serious adverse events such as serious infections, thrombocytopenia, development of malignancy, and severe arthralgias to monitor for safety outcome data. Subjects will have regular physical examinations and laboratory studies throughout the study, as well as telephone interviews.