Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE1
425 participants
INTERVENTIONAL
2008-06-30
2009-05-31
Brief Summary
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The secondary objective is to compare the adverse event (AE) profiles of the two creams.
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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% Taro
Imiquimod 5% manufactured by Taro applied for 16 weeks
Imiquimod 5% manufactured by Taro
Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks
Aldara - Imiquimod 5%
Aldara, Imiquimod 5% applied for 16 weeks
Aldara - Imiquimod 5%
Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks
Vehicle
Imiquimod vehicle applied for 16 weeks
Imiquimod Vehicle manufactured by Taro
Treatment applied as a thin layer to target area once daily, 2 days each week, for 16 weeks
Interventions
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Imiquimod 5% manufactured by Taro
Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks
Aldara - Imiquimod 5%
Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks
Imiquimod Vehicle manufactured by Taro
Treatment applied as a thin layer to target area once daily, 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
18 Years
ALL
No
Sponsors
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Sun Pharmaceutical Industries, Inc.
INDUSTRY
Responsible Party
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Locations
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Investigator Site
Gilbert, Arizona, United States
Investigator Site
Tempe, Arizona, United States
Investigator Site
Tuscon, Arizona, United States
Investigator Site
Denver, Colorado, United States
Investigator Site
Jacksonville, Florida, United States
Investigator Site
Miami, Florida, United States
Investigator Site
Evansvill, Indiana, United States
Investigator Site
Plainfield, Indiana, United States
Investigator Site
Olathe, Kansas, United States
Investigator Site
Wichita, Kansas, United States
Investigator Site
Omaha, Nebraska, United States
Investigator Site
Henderson, Nevada, United States
Investigator Site
Cary, North Carolina, United States
Investigator Site
Hickory, North Carolina, United States
Investigator Site
High Point, North Carolina, United States
Investigator Site
Winston-Salem, North Carolina, United States
Investigator Site
Simpsonville, South Carolina, United States
Investigator Site
Murfreesboro, Tennessee, United States
Investigator Site
College Station, Texas, United States
Investigator Site
Tyler, Texas, United States
Countries
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Other Identifiers
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MIQ-0403
Identifier Type: -
Identifier Source: org_study_id
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