Aldara for the Treatment of Extensive Alopecia Areata
Information source: University of Minnesota
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alopecia Areata
Intervention: Aldara Cream 5% (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Hordinsky, Maria K., MD Official(s) and/or principal investigator(s):
Maria Hordinsky, MD, Principal Investigator, Affiliation: University of Minnesota
Marna Ericson, Ph D, Principal Investigator, Affiliation: University of Minnesota
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.
Clinical Details
Official title: Aldara for the Treatment of Extensive Alopecia Areata
Study design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Primary outcome: To determine the efficacy of Aldara Cream 5% for the treatment of extensive alopecia areata
Secondary outcome: Assess changes in the hair follicle differentiation oand perifollicular inflammation before and after treatment with Aldara Cream5%
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
University of Minnesota, Minneapolis, Minnesota 55455, United States
Additional Information
Starting date: October 2000
Ending date: August 2002
Last updated: November 8, 2006
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