Aldara for the Treatment of Extensive Alopecia Areata
This study has been completed.
Sponsor:
Hordinsky, Maria K., MD
Collaborators:
National Alopecia Areata Foundation
3M
Information provided by:
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00177021
First received: September 9, 2005
Last updated: November 8, 2006
Last verified: November 2006
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | September 9, 2005 | ||||||||
| Last Updated Date | November 8, 2006 | ||||||||
| Start Date ICMJE | October 2000 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
To determine the efficacy of Aldara Cream 5% for the treatment of extensive alopecia areata | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00177021 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Assess changes in the hair follicle differentiation oand perifollicular inflammation before and after treatment with Aldara Cream5% | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | |||||||||
| Original Other Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Aldara for the Treatment of Extensive Alopecia Areata | ||||||||
| Official Title ICMJE | Aldara for the Treatment of Extensive Alopecia Areata | ||||||||
| Brief Summary | We propose to examine the efficacy and tolerability of Aldara Cream 5% for the treatment of extensive alopecia areata. Aldara is a immune-response modifier. The drug induces the production of cytokines which are small, hormone-like proteins involved in cellular communication during immune responses. We hypothesize that this drug will effect the inflammatory cells present around hair follicles in patients with alopecia areata. |
||||||||
| Detailed Description | Ten patients with extensive scalp alopecia areata (>95% hair loss)of less than 2 years duration will be invited to participate in this study. For six months each person will be asked to apply Aldara Cream 5% daily to the right half of the scalp. No drug will be applied to the left side. Skin biopsies will be taken of the right scalp before and at the completion of the therapy. |
||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
||||||||
| Condition ICMJE | Alopecia Areata | ||||||||
| Intervention ICMJE | Drug: Aldara Cream 5% | ||||||||
| Study Arm (s) | |||||||||
| Publications * | |||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 20 | ||||||||
| Completion Date | August 2002 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00177021 | ||||||||
| Other Study ID Numbers ICMJE | 9908M15841 | ||||||||
| Has Data Monitoring Committee | |||||||||
| Responsible Party | |||||||||
| Study Sponsor ICMJE | Hordinsky, Maria K., MD | ||||||||
| Collaborators ICMJE |
|
||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | University of Minnesota - Clinical and Translational Science Institute | ||||||||
| Verification Date | November 2006 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||
