Bioequivalence Study of Two Imiquimod Cream 5%

Taro Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Actinic Keratosis

Treatments: Drug: Imiquimod 5% manufactured by Taro; Drug: Aldara - Imiquimod 5%; Drug: Imiquimod Vehicle manufactured by Taro

Study type: Interventional

Funder types: Industry

Identifiers

NCT00828568

MIQ-0403

Details and patient eligibility

About

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.

Enrollment: 425 patients

Sex: All

Ages: 18+ years old

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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425 participants in 3 patient groups, including a placebo group

Imiquimod 5% Taro

Experimental group

Description:

Imiquimod 5% manufactured by Taro applied for 16 weeks

Treatment:

Drug: Imiquimod 5% manufactured by Taro

Aldara - Imiquimod 5%

Active Comparator group

Description:

Aldara, Imiquimod 5% applied for 16 weeks

Treatment:

Drug: Aldara - Imiquimod 5%

Vehicle

Placebo Comparator group

Description:

Imiquimod vehicle applied for 16 weeks

Treatment:

Drug: Imiquimod Vehicle manufactured by Taro