A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Therapeutic Equivalence Study of Three Imiquimod Cream 5% Treatments for Patients With Actinic Keratosis
Phase 3
Completed
- Conditions
- Actinic Keratosis
- Interventions
- Registration Number
- NCT00859105
- Lead Sponsor
- Apotex Inc.
- Brief Summary
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Bio-equivalence Study
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 497
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Adara 5 % Cream US Adara 5% Cream US Manufactured by 3M, US. Adara 5% Cream Canada Adara 5% Cream Canada Manufactured by 3M, Canada Vehicle Imiquimod Vehicle Manufactured by Apotex
- Primary Outcome Measures
Name Time Method 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. 24 weeks
- Secondary Outcome Measures
Name Time Method The secondary objective is to compare the safety profiles of the three creams. 24 weeks