A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Therapeutic Equivalence Study of Three Imiquimod Cream 5% Treatments for Patients With Actinic Keratosis
NCT ID: NCT00859105
Last Updated: 2009-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
497 participants
INTERVENTIONAL
2008-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Imiquimod 5%
Manufactured by Apotex
Imiquimod 5%: manufactured by Apotex
Treatment applied as a thin layer to target area once a day, 2 days each week, 16 weeks
Adara 5 % Cream US
Manufactured by 3M, US.
Adara 5% Cream US
Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks
Adara 5% Cream Canada
Manufactured by 3M, Canada
Adara 5% Cream Canada
Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks.
Vehicle
Manufactured by Apotex
Imiquimod Vehicle
Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks
Interventions
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Imiquimod 5%: manufactured by Apotex
Treatment applied as a thin layer to target area once a day, 2 days each week, 16 weeks
Adara 5% Cream US
Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks
Adara 5% Cream Canada
Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks.
Imiquimod Vehicle
Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks
Eligibility Criteria
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Inclusion Criteria
* Women either must be 1 year post-menopausal, surgically sterile, or agree to use a medically accepted form or birth control
* Free of any systemic or dermatological disorder
* Any skin type or race, providing the skin pigmentation will allow discernment of erythema
Exclusion Criteria
* History of cutaneous hyperreactivity or facial irritation to topical products
* Engaging in activities involving excessive or prolonged exposure to sunlight
* Receiving systemic cancer chemotherapy, psoralen plus UVA therapy, UVB therapy, laser abrasion, dermabrasion, glycolic acids, or chemical peels 6 months prior to study entry
* Currently using or have used systemic steroids 2 months prior to study
* Currently using or have used on the treatment area over-the-counter retinol products, corticosteroids, cryosurgery, curettage, 5-fluorouracil, or other topical actinic keratosis treatments 28 days prior to randomization
* Pregnant or nursing mothers
* History of allergy or sensitivity to imiquimod or related compounds or other components of the formulation
* Taking immunosuppressant medication
ALL
No
Sponsors
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Apotex Inc.
INDUSTRY
Responsible Party
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Director, Regulatory Affairs U.S.
Principal Investigators
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William Brooks
Role: STUDY_DIRECTOR
Apotex Inc.
Other Identifiers
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IMIQ-TOCR-01RB01-CE
Identifier Type: -
Identifier Source: org_study_id
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