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Aldara for the Treatment of Extensive Alopecia Areata

Primary Purpose

Alopecia Areata

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Aldara Cream 5%
Sponsored by
Hordinsky, Maria K., MD
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia Areata

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Minnesota

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 9, 2005
Last Updated
November 8, 2006
Sponsor
Hordinsky, Maria K., MD
Collaborators
National Alopecia Areata Foundation, 3M
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1. Study Identification

Unique Protocol Identification Number
NCT00177021
Brief Title
Aldara for the Treatment of Extensive Alopecia Areata
Official Title
Aldara for the Treatment of Extensive Alopecia Areata
Study Type
Interventional

2. Study Status

Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
October 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hordinsky, Maria K., MD
Collaborators
National Alopecia Areata Foundation, 3M

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Aldara Cream 5%
Primary Outcome Measure Information:
Title
To determine the efficacy of Aldara Cream 5% for the treatment of extensive alopecia areata
Secondary Outcome Measure Information:
Title
Assess changes in the hair follicle differentiation oand perifollicular inflammation before and after treatment with Aldara Cream5%

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Hordinsky, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marna Ericson, Ph D
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Aldara for the Treatment of Extensive Alopecia Areata

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