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

Sponsor:	Apotex Inc.
Information provided by:	Apotex Inc.
ClinicalTrials.gov Identifier:	NCT00859105

Purpose

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

Condition	Intervention	Phase
Actinic Keratosis	Drug: Imiquimod 5%: manufactured by Apotex Drug: Adara 5% Cream US Drug: Adara 5% Cream Canada Drug: Imiquimod Vehicle	Phase III

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

Resource links provided by NLM:

Drug Information available for: S 26308

U.S. FDA Resources

Further study details as provided by Apotex Inc.:

Primary Outcome Measures:

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. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary objective is to compare the safety profiles of the three creams. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	497
Study Start Date:	February 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Imiquimod 5% Manufactured by Apotex	Drug: Imiquimod 5%: manufactured by Apotex Treatment applied as a thin layer to target area once a day, 2 days each week, 16 weeks
Active Comparator: Adara 5 % Cream US Manufactured by 3M, US.	Drug: Adara 5% Cream US Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks
Active Comparator: Adara 5% Cream Canada Manufactured by 3M, Canada	Drug: Adara 5% Cream Canada Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks.
Placebo Comparator: Vehicle Manufactured by Apotex	Drug: Imiquimod Vehicle Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00859105

Sponsors and Collaborators

Apotex Inc.

Investigators

Study Director:

William Brooks

Apotex Inc.

More Information

No publications provided

Responsible Party:	Bernice Tao, Director, Regulatory Affairs U.S.
ClinicalTrials.gov Identifier:	NCT00859105 History of Changes
Other Study ID Numbers:	IMIQ-TOCR-01RB01-CE
Study First Received:	March 9, 2009
Last Updated:	March 9, 2009
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms
Imiquimod
Adjuvants, Immunologic

Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Interferon Inducers

ClinicalTrials.gov processed this record on February 09, 2012