Aldara for the Treatment of Extensive Alopecia Areata

NCT00177021 | Completed Phase 4

• 1 other identifier: 9908M15841
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (1)

• To determine the efficacy of Aldara Cream 5% for the treatment of extensive alopecia areata

Secondary Outcomes (1)

• Assess changes in the hair follicle differentiation oand perifollicular inflammation before and after treatment with Aldara Cream5%

Interventions

Aldara Cream 5% DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hordinsky, Maria K., MD: lead
• National Alopecia Areata Foundation: collaborator
• 3M: collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Maria Hordinsky, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Marna Ericson, Ph D

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: October 1, 2000
• Study Completion: August 1, 2002
• Last Updated: November 13, 2006

Record last verified: 2006-11

Locations

US (1)