Characteristics of T Cells From Alopecia Areata Scalp Skin Before and After Treatment With Aldara 5%
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ClinicalTrials.gov Identifier: NCT00176943 |
Recruitment Status :
Completed
First Posted : September 15, 2005
Last Update Posted : February 14, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alopecia Areata | Drug: Aldara Cream 5% | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 20 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Official Title: | Phenotype and Cytokine Production Characteristics of T Cells From Alopecia Areata Scalp Skin Before and After Aldara 5% Cream Using Flow Cytometry |
Study Start Date : | October 2000 |
Actual Primary Completion Date : | August 2002 |
Actual Study Completion Date : | August 2002 |

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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00176943
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 55455 |
Principal Investigator: | Maria Hordinsky, MD | University of Minnesota | |
Principal Investigator: | Marna Ericson, PhD | University of Minnesota |
Responsible Party: | Hordinsky, Maria K., MD |
ClinicalTrials.gov Identifier: | NCT00176943 |
Other Study ID Numbers: |
0009M64941 |
First Posted: | September 15, 2005 Key Record Dates |
Last Update Posted: | February 14, 2014 |
Last Verified: | February 2014 |
Alopecia Alopecia Areata Hypotrichosis Hair Diseases Skin Diseases Pathological Conditions, Anatomical |
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