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Bioequivalence Study of Two Imiquimod Cream 5%

Primary Purpose

Actinic Keratosis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Imiquimod 5% manufactured by Taro
Aldara - Imiquimod 5%
Imiquimod Vehicle manufactured by Taro
Sponsored by
Taro Pharmaceuticals USA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratosis focused on measuring Actinic Keratosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Investigator Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Imiquimod 5% Taro

Aldara - Imiquimod 5%

Vehicle

Arm Description

Imiquimod 5% manufactured by Taro applied for 16 weeks

Aldara, Imiquimod 5% applied for 16 weeks

Imiquimod vehicle applied for 16 weeks

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 22, 2009
Last Updated
December 21, 2013
Sponsor
Taro Pharmaceuticals USA
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1. Study Identification

Unique Protocol Identification Number
NCT00828568
Brief Title
Bioequivalence Study of Two Imiquimod Cream 5%
Official Title
A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Therapeutic Equivalence Study of Two Imiquimod Cream 5% Treatments for Patients With Actinic Keratosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taro Pharmaceuticals USA

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis
Keywords
Actinic Keratosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
425 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Imiquimod 5% Taro
Arm Type
Experimental
Arm Description
Imiquimod 5% manufactured by Taro applied for 16 weeks
Arm Title
Aldara - Imiquimod 5%
Arm Type
Active Comparator
Arm Description
Aldara, Imiquimod 5% applied for 16 weeks
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Imiquimod vehicle applied for 16 weeks
Intervention Type
Drug
Intervention Name(s)
Imiquimod 5% manufactured by Taro
Intervention Description
Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks
Intervention Type
Drug
Intervention Name(s)
Aldara - Imiquimod 5%
Intervention Description
Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks
Intervention Type
Drug
Intervention Name(s)
Imiquimod Vehicle manufactured by Taro
Intervention Description
Treatment applied as a thin layer to target area once daily, 2 days each week, for 16 weeks
Primary Outcome Measure Information:
Title
Number of Participants With 100% Clearance of Actinic Keratosis Lesions: Comparison of Taro Imiquimod 5% and Aldara-Imiquimod 5%
Description
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.
Time Frame
24 weeks
Title
Number of Participants in Intention-to-treat (ITT)Population With 100% Clearance of Actinic Keratosis (AK) Lesions Identified at Baseline
Description
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.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Patients Reporting at Least One Adverse Event
Description
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.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Investigator Site
City
Gilbert
State/Province
Arizona
Country
United States
Facility Name
Investigator Site
City
Tempe
State/Province
Arizona
Country
United States
Facility Name
Investigator Site
City
Tuscon
State/Province
Arizona
Country
United States
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City
Denver
State/Province
Colorado
Country
United States
Facility Name
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Jacksonville
State/Province
Florida
Country
United States
Facility Name
Investigator Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
Investigator Site
City
Evansvill
State/Province
Indiana
Country
United States
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Plainfield
State/Province
Indiana
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United States
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Olathe
State/Province
Kansas
Country
United States
Facility Name
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Wichita
State/Province
Kansas
Country
United States
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Omaha
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Nebraska
Country
United States
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Henderson
State/Province
Nevada
Country
United States
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Cary
State/Province
North Carolina
Country
United States
Facility Name
Investigator Site
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Hickory
State/Province
North Carolina
Country
United States
Facility Name
Investigator Site
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High Point
State/Province
North Carolina
Country
United States
Facility Name
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Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Investigator Site
City
Simpsonville
State/Province
South Carolina
Country
United States
Facility Name
Investigator Site
City
Murfreesboro
State/Province
Tennessee
Country
United States
Facility Name
Investigator Site
City
College Station
State/Province
Texas
Country
United States
Facility Name
Investigator Site
City
Tyler
State/Province
Texas
Country
United States

12. IPD Sharing Statement

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Bioequivalence Study of Two Imiquimod Cream 5%

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