Actinic Keratosis
Conditions
Brief summary
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Bio-equivalence Study
Interventions
DRUGImiquimod 5%: manufactured by Apotex
Treatment applied as a thin layer to target area once a day, 2 days each week, 16 weeks
DRUGAdara 5% Cream US
Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks
DRUGAdara 5% Cream Canada
Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks.
DRUGImiquimod Vehicle
Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks
Sponsors
Apotex Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| The secondary objective is to compare the safety profiles of the three creams. | 24 weeks |
Outcome results
None listed