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Bioequivalence Study of Two Imiquimod Cream 5%

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00828568
First received: January 22, 2009
Last updated: December 21, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Actinic Keratosis
Drug: Imiquimod 5% manufactured by Taro
Drug: Aldara - Imiquimod 5%
Drug: Imiquimod Vehicle manufactured by Taro
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Therapeutic Equivalence Study of Two Imiquimod Cream 5% Treatments for Patients With Actinic Keratosis

Resource links provided by NLM:


Further study details as provided by Taro Pharmaceuticals USA:

Primary Outcome Measures:
  • Number of Participants With 100% Clearance of Actinic Keratosis Lesions: Comparison of Taro Imiquimod 5% and Aldara-Imiquimod 5% [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

    Uses per protocol (PP) population.

    Each patient is assessed at 24 weeks. Actinic keratosis (AK) lesions that were identified and measured at baseline are reevaluated at the conclusion of the study. If all lesions that were identified at baseline are no longer present and there are no new lesions, the patient is 100% clear of AK lesions.


  • Number of Participants in Intention-to-treat (ITT)Population With 100% Clearance of Actinic Keratosis (AK) Lesions Identified at Baseline [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

    Uses ITT population. Three patients (1 Imiquimod 5% Taro and 2 Imiquimod Aldara) did not have a follow-up visit after dosing and were excluded from ITT. Three patients (2 Imiquimod 5% Taro and 1 Imiquimod Aldara) were not evaluable at the 24-week visit and were not in the analysis.

    Each patient is assessed at 24 weeks. Actinic keratosis (AK) lesions that were identified and measured at baseline are reevaluated at the conclusion of the study. If all lesions that were identified at baseline are no longer present and there are no new lesions, the patient is 100% clear of AK lesions.



Secondary Outcome Measures:
  • Patients Reporting at Least One Adverse Event [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    For all patients who received a single dose, adverse events were collected at each follow-up visit. Any patient reporting a single or multiple adverse events at any visit was conisdered to have had at least one adverse event.


Enrollment: 425
Study Start Date: June 2008
Study Completion Date: May 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Imiquimod 5% Taro
Imiquimod 5% manufactured by Taro applied for 16 weeks
Drug: Imiquimod 5% manufactured by Taro
Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks
Active Comparator: Aldara - Imiquimod 5%
Aldara, Imiquimod 5% applied for 16 weeks
Drug: Aldara - Imiquimod 5%
Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks
Placebo Comparator: Vehicle
Imiquimod vehicle applied for 16 weeks
Drug: Imiquimod Vehicle manufactured by Taro
Treatment applied as a thin layer to target area once daily, 2 days each week, for 16 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00828568

Locations
United States, Arizona
Investigator Site
Gilbert, Arizona, United States
Investigator Site
Tempe, Arizona, United States
Investigator Site
Tuscon, Arizona, United States
United States, Colorado
Investigator Site
Denver, Colorado, United States
United States, Florida
Investigator Site
Jacksonville, Florida, United States
Investigator Site
Miami, Florida, United States
United States, Indiana
Investigator Site
Evansvill, Indiana, United States
Investigator Site
Plainfield, Indiana, United States
United States, Kansas
Investigator Site
Olathe, Kansas, United States
Investigator Site
Wichita, Kansas, United States
United States, Nebraska
Investigator Site
Omaha, Nebraska, United States
United States, Nevada
Investigator Site
Henderson, Nevada, United States
United States, North Carolina
Investigator Site
Cary, North Carolina, United States
Investigator Site
Hickory, North Carolina, United States
Investigator Site
High Point, North Carolina, United States
Investigator Site
Winston-Salem, North Carolina, United States
United States, South Carolina
Investigator Site
Simpsonville, South Carolina, United States
United States, Tennessee
Investigator Site
Murfreesboro, Tennessee, United States
United States, Texas
Investigator Site
College Station, Texas, United States
Investigator Site
Tyler, Texas, United States
Sponsors and Collaborators
Taro Pharmaceuticals USA
  More Information

No publications provided

Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT00828568     History of Changes
Other Study ID Numbers: MIQ-0403
Study First Received: January 22, 2009
Results First Received: September 17, 2009
Last Updated: December 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Taro Pharmaceuticals USA:
Actinic Keratosis

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Neoplasms
Precancerous Conditions
Skin Diseases
Imiquimod
Adjuvants, Immunologic
Antineoplastic Agents
Immunologic Factors
Interferon Inducers
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014