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

Actinic Keratosis Clinical Trial

Official title:

A Multicenter, Double-Blind, Vehical-Controlled Study Comparing Imiquimod Cream, 5% (Apotex Inc.) to Aldara™ Cream, 5%(3M Pharmaceutials, U.S.) and Aldara™ Cream, 5%(3M Pharmaceuticals, Canada) in the Treatments of Actinic Keratosis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00859105
• Other study ID #: IMIQ-TOCR-01RB01-CE
• Status: Completed
• Phase: Phase 3
• First received: March 9, 2009
• Last updated: March 9, 2009
• Start date: February 2008

Study information

• Verified date: March 2009
• Source: Apotex Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 497
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• Imiquimod 5%: manufactured by Apotex
Treatment applied as a thin layer to target area once a day, 2 days each week, 16 weeks
• Adara 5% Cream US
Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks
• Adara 5% Cream Canada
Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks.
• Imiquimod Vehicle
Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Apotex Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The secondary objective is to compare the safety profiles of the three creams.		24 weeks	Yes