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

Apotex

Status and phase: Completed; Phase 3

Conditions: Actinic Keratosis

Treatments: Drug: Adara 5% Cream US; Drug: Adara 5% Cream Canada; Drug: Imiquimod 5%: manufactured by Apotex; Drug: Imiquimod Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT00859105

IMIQ-TOCR-01RB01-CE

Details and patient eligibility

About

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Bio-equivalence Study

Enrollment: 497 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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497 participants in 4 patient groups, including a placebo group

Imiquimod 5%

Experimental group

Description:

Manufactured by Apotex

Treatment:

Drug: Imiquimod 5%: manufactured by Apotex

Adara 5 % Cream US

Active Comparator group

Description:

Manufactured by 3M, US.

Treatment:

Drug: Adara 5% Cream US

Adara 5% Cream Canada

Active Comparator group

Description:

Manufactured by 3M, Canada

Treatment:

Drug: Adara 5% Cream Canada

Vehicle

Placebo Comparator group

Description:

Manufactured by Apotex

Treatment:

Drug: Imiquimod Vehicle