Clincosm LogoSign in Get a demo

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

Sponsor
Apotex Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00859105
Collaborator
(none)
497
Enrollment
4
Arms

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Imiquimod 5%: manufactured by Apotex
  • Drug: Adara 5% Cream US
  • Drug: Adara 5% Cream Canada
  • Drug: Imiquimod Vehicle
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
497 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, 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.
Study Start Date :
Feb 1, 2008
Actual Primary Completion Date :
Nov 1, 2008

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  1. The secondary objective is to compare the safety profiles of the three creams. [24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

Sponsors and Collaborators

  • Apotex Inc.

Investigators

  • Study Director: William Brooks, Apotex Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00859105
Other Study ID Numbers:
  • IMIQ-TOCR-01RB01-CE
First Posted:
Mar 10, 2009
Last Update Posted:
Mar 10, 2009
Last Verified:
Mar 1, 2009
Additional relevant MeSH terms:
Keratosis, Actinic
Keratosis
Imiquimod

Study Results

No Results Posted as of Mar 10, 2009