Clinical trial NCT00177021: Aldara for the Treatment of Extensive Alopecia Areata
Official title: Aldara for the Treatment of Extensive Alopecia Areata
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alopecia Areata
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Alopecia Areata Foundation
name: 3M
First posted: 2005-09-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: To determine the efficacy of Aldara Cream 5% for the treatment of extensive alopecia areata
Secondary outcomes:
measure: Assess changes in the hair follicle differentiation oand perifollicular inflammation before and after treatment with Aldara Cream5%
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Maria Hordinsky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Marna Ericson, Ph D
role: PRINCIPAL_INVESTIGATOR
References: