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Characteristics of T Cells From Alopecia Areata Scalp Skin Before and After Treatment With Aldara 5%

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00176943
First Posted: September 15, 2005
Last Update Posted: February 14, 2014
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.
Collaborator:
National Alopecia Areata Foundation
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute ( Hordinsky, Maria K., MD )
September 12, 2005
September 15, 2005
February 14, 2014
October 2000
August 2002   (Final data collection date for primary outcome measure)
To determine the phenotypic characteristics of T lymphocytes infiltrating scalp dermis and epidermis in patients with extensive alopecia areata before and after treatment with Aldara Cream 5% an immunomodulatory agent.
Same as current
Complete list of historical versions of study NCT00176943 on ClinicalTrials.gov Archive Site
To further characterize the functional potential of these cells using the nascent technology of intracellular cytokine staining.
Same as current
Not Provided
Not Provided
 
Characteristics of T Cells From Alopecia Areata Scalp Skin Before and After Treatment With Aldara 5%
Phenotype and Cytokine Production Characteristics of T Cells From Alopecia Areata Scalp Skin Before and After Aldara 5% Cream Using Flow Cytometry
It is thought that alopecia areata occurs as the result of an inappropriate response of the body's own immune system to certain substances in or around the hair follicle. We will be examining the efficacy of Aldara Cream 5% in treating extensive alopecia areata and observe its affect on the hair follicle.
We will examine how the application of Aldara Cream 5% daily for 6 months will affect the hair follicle and the inflammation present in the skin of patients with alopecia areata. In the study we will obtain additional scalp biopsies to examine how the drug affects the quality and state of activity of the immune cells in the biopsy specimens. This type of information will provide data about the behavior of these inflammatory cells in mediating the hair loss associated with alopecia areata and how this behavior may be effected by Aldara Cream 5% treatment. Such information may be valuable to the successful management of alopecia areata.
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
August 2002   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Must be in good health.
  • No topical or systemic treatment for alopecia areata for at least 2 weeks prior to study initiation.
  • Must be at least 18 years of age and older
  • Will have to have extensive scalp alopecia areata (>95% involvement) of less than 2 years duration.
  • Willing to refrain from other alopecia areata treatments during the course of the study.
  • Will have to agree to shampoo their scalp daily with Free and Clear shampoo. Participant in "Aldara for the Treatment of Extensive Alopecia Areata" study.

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 to the patient
  • Significant abnormalities on screening clinical evaluation.
  • Previous use of Aldara Cream 5%.
  • A history of drug or alcohol abuse.
  • Use of UV 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.
  • Alterations in thyroid medication within 6 weeks of study initiation. Pregnant or nursing females. Not participating in the "Aldara for the Treatment of Extensive Alopecia Areata" study.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00176943
0009M64941
No
Not Provided
Not Provided
University of Minnesota - Clinical and Translational Science Institute ( Hordinsky, Maria K., MD )
Hordinsky, Maria K., MD
National Alopecia Areata Foundation
Principal Investigator: Maria Hordinsky, MD University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Marna Ericson, PhD University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
February 2014

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