Bioequivalence Study of Two Imiquimod Cream 5%

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

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.

Study Overview

• Status: Completed
• Conditions: Actinic Keratosis
• Intervention / Treatment: Drug: Imiquimod 5% manufactured by Taro; Drug: Aldara - Imiquimod 5%; Drug: Imiquimod Vehicle manufactured by Taro

• Study Type: Interventional
• Enrollment (Actual): 425
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Gilbert, Arizona, United States
      • Investigator Site
    • Tempe, Arizona, United States
      • Investigator Site
    • Tuscon, Arizona, United States
      • Investigator Site
  • Colorado
    • Denver, Colorado, United States
      • Investigator Site
  • Florida
    • Jacksonville, Florida, United States
      • Investigator Site
    • Miami, Florida, United States
      • Investigator Site
  • Indiana
    • Evansvill, Indiana, United States
      • Investigator Site
    • Plainfield, Indiana, United States
      • Investigator Site
  • Kansas
    • Olathe, Kansas, United States
      • Investigator Site
    • Wichita, Kansas, United States
      • Investigator Site
  • Nebraska
    • Omaha, Nebraska, United States
      • Investigator Site
  • Nevada
    • Henderson, Nevada, United States
      • Investigator Site
  • North Carolina
    • 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
      • Investigator Site
  • South Carolina
    • Simpsonville, South Carolina, United States
      • Investigator Site
  • Tennessee
    • Murfreesboro, Tennessee, United States
      • Investigator Site
  • Texas
    • College Station, Texas, United States
      • Investigator Site
    • Tyler, Texas, United States
      • Investigator Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With 100% Clearance of Actinic Keratosis Lesions: Comparison of Taro Imiquimod 5% and Aldara-Imiquimod 5%	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.	24 weeks
Number of Participants in Intention-to-treat (ITT)Population With 100% Clearance of Actinic Keratosis (AK) Lesions Identified at Baseline	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.	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients Reporting at Least One Adverse Event	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.	24 weeks

Collaborators and Investigators

• Sponsor: Taro Pharmaceuticals USA

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (ACTUAL): March 1, 2009
• Study Completion (ACTUAL): May 1, 2009

Study Registration Dates

• First Submitted: January 22, 2009
• First Submitted That Met QC Criteria: January 23, 2009
• First Posted (ESTIMATE): January 26, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): January 28, 2014
• Last Update Submitted That Met QC Criteria: December 21, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Actinic Keratosis
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis; Physiological Effects of Drugs; Antineoplastic Agents; Immunologic Factors; Adjuvants, Immunologic; Interferon Inducers; Imiquimod
• Other Study ID Numbers: MIQ-0403