Bioequivalence Study of Two Imiquimod Cream 5%

Actinic Keratosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00828568
• Other study ID #: MIQ-0403
• 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

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

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