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

NCT00859105 | Completed Phase 3 DMC

• 1 other identifier: IMIQ-TOCR-01RB01-CE
• Study Type: interventional
• Target: 497
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The secondary objective is to compare the safety profiles of the three creams.

  24 weeks

Study Arms (4)

Imiquimod 5%

EXPERIMENTAL

Manufactured by Apotex

Drug: Imiquimod 5%: manufactured by Apotex

Adara 5 % Cream US

ACTIVE COMPARATOR

Manufactured by 3M, US.

Drug: Adara 5% Cream US

Adara 5% Cream Canada

ACTIVE COMPARATOR

Manufactured by 3M, Canada

Drug: Adara 5% Cream Canada

Vehicle

PLACEBO COMPARATOR

Manufactured by Apotex

Drug: Imiquimod Vehicle

Interventions

Imiquimod 5%: manufactured by Apotex DRUG

Treatment applied as a thin layer to target area once a day, 2 days each week, 16 weeks

Imiquimod 5%

Adara 5% Cream US DRUG

Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks

Adara 5 % Cream US

Adara 5% Cream Canada DRUG

Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks.

Adara 5% Cream Canada

Imiquimod Vehicle DRUG

Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks

Vehicle

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Apotex Inc.: lead

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Imiquimod

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• William Brooks

  Apotex Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 9, 2009
• First Posted: March 10, 2009
• Study Start: February 1, 2008
• Primary Completion: November 1, 2008
• Last Updated: March 10, 2009

Record last verified: 2009-03