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Aldara for the Treatment of Extensive Alopecia Areata

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00177021
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : November 13, 2006
Sponsor:
Collaborators:
National Alopecia Areata Foundation
3M
Information provided by:
University of Minnesota

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 15, 2005
Last Update Posted Date November 13, 2006
Study Start Date  ICMJE October 2000
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)		 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
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)		 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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alopecia Areata
Intervention  ICMJE Drug: Aldara Cream 5%
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   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
 (submitted: September 12, 2005)		 20
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE August 2002
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Must give written informed consent.
  • Must be 18 years of age, male or female of any race.
  • Subjects must have extensive scalp alopecia areata (>95% involvement) of less than 2 years duration.
  • In good general and mental health based on a medical history and physical exam.
  • Patient must be willing to refrain from all other alopecia areata treatments during the course of the study.
  • Must agree to shampoo daily with Free and Clear shampoo.

Exclusion Criteria:

  • History of any illness or condition that in the opinion of the investigator might confound the results of the study or pose additional risk in administering the drug to the patient.
  • Significant abnormalities on screening clinical examination.
  • Previous use of Aldara Cream 5%
  • History of drug or alcohol abuse.
  • Use of ultraviolet radiation, including tanning beds and PUVA therapy for treatment of acne, psoriasis, or any other skin condition within 2 months prior to study initiation.
  • Use of systemic or topical glucocorticoids, corticosteroids. estrogenic, progestogenic, androgenic, or antiandrogen drugs, cyclosporine, FK506 or immunotherapy with DNCB, SADBE, or DCP within 6 months of study initiation.
  • Use of a topical medication within six weeks prior to the study.
  • Alterations in thyroid medication within 6 months of study initiation.
  • Pregnant or nursing females.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00177021
Other Study ID Numbers  ICMJE 9908M15841
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Hordinsky, Maria K., MD
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • National Alopecia Areata Foundation
  • 3M
Investigators  ICMJE
Principal Investigator: Maria Hordinsky, MD University of Minnesota
Principal Investigator: Marna Ericson, Ph D University of Minnesota
PRS Account University of Minnesota
Verification Date November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP