Bioequivalence Study of Two Imiquimod Cream 5%

Phase 1

Completed

Interventions: Drug: Imiquimod 5% manufactured by Taro
Drug: Aldara - Imiquimod 5%
Drug: Imiquimod Vehicle manufactured by Taro

Brief Summary: The primary objectives are to establish the therapeutic equivalence of imiquimod cream 5%, manufactured by Taro Pharmaceuticals Inc. and Aldara (imiquimod) cream, manufactured by 3M, and to show superiority over vehicle in the treatment of AK.

The secondary objective is to compare the adverse event (AE) profiles of the two creams.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Imiquimod 5% Taro	Imiquimod 5% manufactured by Taro	Imiquimod 5% manufactured by Taro applied for 16 weeks
Aldara - Imiquimod 5%	Aldara - Imiquimod 5%	Aldara, Imiquimod 5% applied for 16 weeks
Vehicle	Imiquimod Vehicle manufactured by Taro	Imiquimod vehicle applied for 16 weeks

Primary Outcome Measures

Name	Time	Method
Number of Participants With 100% Clearance of Actinic Keratosis Lesions: Comparison of Taro Imiquimod 5% and Aldara-Imiquimod 5%	24 weeks	Uses per protocol (PP) population. Each patient is assessed at 24 weeks. Actinic keratosis (AK) lesions that were identified and measured at baseline are reevaluated at the conclusion of the study. If all lesions that were identified at baseline are no longer present and there are no new lesions, the patient is 100% clear of AK lesions.
Number of Participants in Intention-to-treat (ITT)Population With 100% Clearance of Actinic Keratosis (AK) Lesions Identified at Baseline	24 weeks	Uses ITT population. Three patients (1 Imiquimod 5% Taro and 2 Imiquimod Aldara) did not have a follow-up visit after dosing and were excluded from ITT. Three patients (2 Imiquimod 5% Taro and 1 Imiquimod Aldara) were not evaluable at the 24-week visit and were not in the analysis. Each patient is assessed at 24 weeks. Actinic keratosis (AK) lesions that were identified and measured at baseline are reevaluated at the conclusion of the study. If all lesions that were identified at baseline are no longer present and there are no new lesions, the patient is 100% clear of AK lesions.

Secondary Outcome Measures

Name	Time	Method
Patients Reporting at Least One Adverse Event	24 weeks	For all patients who received a single dose, adverse events were collected at each follow-up visit. Any patient reporting a single or multiple adverse events at any visit was conisdered to have had at least one adverse event.