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Completed

NCT Number: NCT00176943

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aldara Cream 5%

Drug

Primary outcomes

  1. 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.

Secondary outcomes

  1. To further characterize the functional potential of these cells using the nascent technology of intracellular cytokine staining.

Sponsors and collaborators

Lead sponsor

Hordinsky, Maria K., MD

Indiv

Collaborators

  • National Alopecia Areata Foundation

Registry information

Official study title

Phenotype and Cytokine Production Characteristics of T Cells From Alopecia Areata Scalp Skin Before and After Aldara 5% Cream Using Flow Cytometry

Important dates

Study start
2000
Primary completion
2002
Study completion
2002
First posted
Sep 15, 2005
Registry last updated
Feb 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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