Status:
COMPLETED
A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Therapeutic Equivalence Study of Three Imiquimod Cream 5% Treatments for Patients With Actinic Keratosis
Lead Sponsor:
Apotex Inc.
Conditions:
Actinic Keratosis
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Bio-equivalence Study
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
497 Patients enrolled
Trial Details
Trial ID
NCT00859105
Start Date
February 1 2008
Last Update
March 10 2009
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