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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00828568
Other study ID # MIQ-0403
Secondary ID
Status Completed
Phase Phase 1
First received January 22, 2009
Last updated December 21, 2013
Start date June 2008
Est. completion date May 2009

Study information

Verified date December 2013
Source Taro Pharmaceuticals USA
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 425
Est. completion date May 2009
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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
Aldara - Imiquimod 5%
Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks
Imiquimod Vehicle manufactured by Taro
Treatment applied as a thin layer to target area once daily, 2 days each week, for 16 weeks

Locations

Country Name City State
United States Investigator Site Cary North Carolina
United States Investigator Site College Station Texas
United States Investigator Site Denver Colorado
United States Investigator Site Evansvill Indiana
United States Investigator Site Gilbert Arizona
United States Investigator Site Henderson Nevada
United States Investigator Site Hickory North Carolina
United States Investigator Site High Point North Carolina
United States Investigator Site Jacksonville Florida
United States Investigator Site Miami Florida
United States Investigator Site Murfreesboro Tennessee
United States Investigator Site Olathe Kansas
United States Investigator Site Omaha Nebraska
United States Investigator Site Plainfield Indiana
United States Investigator Site Simpsonville South Carolina
United States Investigator Site Tempe Arizona
United States Investigator Site Tuscon Arizona
United States Investigator Site Tyler Texas
United States Investigator Site Wichita Kansas
United States Investigator Site Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Taro Pharmaceuticals USA

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Primary 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 No
Secondary 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 Yes
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