Back to resultsA Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Therapeutic Equivalence Study of Three Imiquimod Cream 5% Treatments for Patients With Actinic Keratosis
Primary Purpose
Actinic Keratosis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Imiquimod 5%: manufactured by Apotex
Adara 5% Cream US
Adara 5% Cream Canada
Imiquimod Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Actinic Keratosis
Eligibility Criteria
Inclusion Criteria:
- Patients must have 4 to 8 clinically diagnosed, non-hyperkeratotic, non-hypertrophic AK lesions within a 25 cm2 contiguous treatment area on either the face or balding scalp
- 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:
- Basal cell or squamous cell carcinoma, or other possible confounding skin conditions (on face and scalp)
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Imiquimod 5%
Adara 5 % Cream US
Adara 5% Cream Canada
Vehicle
Arm Description
Manufactured by Apotex
Manufactured by 3M, US.
Manufactured by 3M, Canada
Manufactured by Apotex
Outcomes
Primary Outcome Measures
The primary objectives are to establish the therapeutic equivalence of imiquimod cream 5%, manufactured by Apotex Inc. and two Aldara (imiquimod) creams, manufactured by 3M (US & Canada) , and to show superiority over vehicle in the treatment of AK.
Secondary Outcome Measures
The secondary objective is to compare the safety profiles of the three creams.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00859105
Brief Title
A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Therapeutic Equivalence Study of Three Imiquimod Cream 5% Treatments for Patients With Actinic Keratosis
Official Title
A Multicenter, Double-Blind, Vehical-Controlled Study Comparing Imiquimod Cream, 5% (Apotex Inc.) to Aldara™ Cream, 5%(3M Pharmaceutials, U.S.) and Aldara™ Cream, 5%(3M Pharmaceuticals, Canada) in the Treatments of Actinic Keratosis.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Apotex Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Bio-equivalence Study
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
497 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Imiquimod 5%
Arm Type
Experimental
Arm Description
Manufactured by Apotex
Arm Title
Adara 5 % Cream US
Arm Type
Active Comparator
Arm Description
Manufactured by 3M, US.
Arm Title
Adara 5% Cream Canada
Arm Type
Active Comparator
Arm Description
Manufactured by 3M, Canada
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Manufactured by Apotex
Intervention Type
Drug
Intervention Name(s)
Imiquimod 5%: manufactured by Apotex
Intervention Description
Treatment applied as a thin layer to target area once a day, 2 days each week, 16 weeks
Intervention Type
Drug
Intervention Name(s)
Adara 5% Cream US
Intervention Description
Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks
Intervention Type
Drug
Intervention Name(s)
Adara 5% Cream Canada
Intervention Description
Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks.
Intervention Type
Drug
Intervention Name(s)
Imiquimod Vehicle
Intervention Description
Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks
Primary Outcome Measure Information:
Title
The primary objectives are to establish the therapeutic equivalence of imiquimod cream 5%, manufactured by Apotex Inc. and two Aldara (imiquimod) creams, manufactured by 3M (US & Canada) , and to show superiority over vehicle in the treatment of AK.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
The secondary objective is to compare the safety profiles of the three creams.
Time Frame
24 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must have 4 to 8 clinically diagnosed, non-hyperkeratotic, non-hypertrophic AK lesions within a 25 cm2 contiguous treatment area on either the face or balding scalp
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:
Basal cell or squamous cell carcinoma, or other possible confounding skin conditions (on face and scalp)
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Brooks
Organizational Affiliation
Apotex Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Therapeutic Equivalence Study of Three Imiquimod Cream 5% Treatments for Patients With Actinic Keratosis
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