Aldara for the Treatment of Extensive Alopecia Areata

This study has been completed.
Sponsor:
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

September 9, 2005
November 8, 2006
October 2000
Not Provided
To determine the efficacy of Aldara Cream 5% for the treatment of extensive alopecia areata
Same as current
Complete list of historical versions of study NCT00177021 on ClinicalTrials.gov Archive Site
Assess changes in the hair follicle differentiation oand perifollicular inflammation before and after treatment with Aldara Cream5%
Same as current
Not Provided
Not Provided
 
Aldara for the Treatment of Extensive Alopecia Areata
Aldara for the Treatment of Extensive Alopecia Areata

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Alopecia Areata
Drug: Aldara Cream 5%
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
August 2002
Not Provided

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00177021
9908M15841
Not Provided
Not Provided
Hordinsky, Maria K., MD
  • National Alopecia Areata Foundation
  • 3M
Principal Investigator: Maria Hordinsky, MD University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Marna Ericson, Ph D University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
November 2006

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