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: Drug: Adara 5% Cream US; Drug: Adara 5% Cream Canada; Drug: Imiquimod Vehicle

• 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

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2008-11
• Status Verified: 2009-03
• Study First Submitted: 2009-03-09
• Study First Submitted QC: 2009-03-09
• Last Update Submitted: 2009-03-09
• Study First Posted: 2009-03-10
• Last Update Posted: 2009-03-10

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