Bioequivalence Study of Two Imiquimod Cream 5%

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Therapeutic Equivalence Study of Two Imiquimod Cream 5% Treatments for Patients With Actinic Keratosis

Conditions
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Actinic Keratosis

Intervention / Treatment
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* Drug: Imiquimod 5% manufactured by Taro
* Drug: Aldara - Imiquimod 5%
* Drug: Imiquimod Vehicle manufactured by Taro


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Imiquimod 5% Taro<br>Imiquimod 5% manufactured by Taro applied for 16 weeks | Drug: Imiquimod 5% manufactured by Taro<br>* Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks<br>|
| Active Comparator: Aldara - Imiquimod 5%<br>Aldara, Imiquimod 5% applied for 16 weeks | Drug: Aldara - Imiquimod 5%<br>* Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks<br>|
| Placebo Comparator: Vehicle<br>Imiquimod vehicle applied for 16 weeks | Drug: Imiquimod Vehicle manufactured by Taro<br>* Treatment applied as a thin layer to target area once daily, 2 days each week, for 16 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With 100% Clearance of Actinic Keratosis Lesions: Comparison of Taro Imiquimod 5% and Aldara-Imiquimod 5% | 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. | 24 weeks | 
| Number of Participants in Intention-to-treat (ITT)Population With 100% Clearance of Actinic Keratosis (AK) Lesions Identified at Baseline | 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. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients Reporting at Least One Adverse Event | 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. | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Actinic Keratosis