NCT00177021

CompletedPhase 4

Aldara for the Treatment of Extensive Alopecia Areata

Hordinsky, Maria K., MD Source

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Other study identifiers

Sponsor study identifier

9908M15841

Study Type

interventional

Reported enrollment (type unavailable)

20

Locations

1 country

Sites

1

Timeline

Study Start

October 2000

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

August 2002

Date type not reported

This date has not been verified as actual or estimated.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 20 participants
Study completion date: August 2002
Date type not reported
This date has not been verified as actual or estimated.
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
October 2000
Date type not reported
This date has not been verified as actual or estimated.
Study Completion
August 2002
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 9, 2005
Actual (reported)
First Posted
September 15, 2005
Actual (reported)

Last Updated: November 13, 2006
Status Verified: November 2006
Last Update Submitted: November 8, 2006

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (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.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

AlopeciaHypotrichosisHair DiseasesSkin DiseasesSkin 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 2000

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

August 2002

Date type not reported

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Phase 4Terminated

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Phase 4Unknown

NCT07459933

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Phase 4Not Yet Recruiting

NCT04412148

Modified SALT Score for Alopecia Areata

Phase 4Unknown

NCT03473600

Cryotherapy Versus Steroids In Alopecia Areata:Trichoscopic Evaluation

Phase 4Unknown

NCT04793945

Excimer Light and Topical Steroid in Treatment of Alopecia Areata

Phase 4Unknown

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.

Contact the study team to confirm eligibility.

Othercollaborator

This date has not been verified as actual or estimated.

Last Updated

November 13, 2006

Record last verified: 2006-11

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT00177021
Data provider: ClinicalTrials.gov
Source updated: 2006-11-13
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:24:45 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations