Clinical trial NCT00828568: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Actinic Keratosis
Keywords: Actinic Keratosis
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2009-01-26
Enrollment: 425
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants With 100% Clearance of Actinic Keratosis Lesions: Comparison of Taro Imiquimod 5% and Aldara-Imiquimod 5%
timeFrame: 24 weeks
measure: Number of Participants in Intention-to-treat (ITT)Population With 100% Clearance of Actinic Keratosis (AK) Lesions Identified at Baseline
timeFrame: 24 weeks
Secondary outcomes:
measure: Patients Reporting at Least One Adverse Event
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Investigator Site
state: Arizona
city: Tempe
country: United States
facility: Investigator Site
state: Arizona
city: Tuscon
country: United States
facility: Investigator Site
state: Arizona
city: Denver
country: United States
facility: Investigator Site
state: Colorado
city: Jacksonville
country: United States
facility: Investigator Site
state: Florida
city: Miami
country: United States
facility: Investigator Site
state: Florida
city: Evansvill
country: United States
facility: Investigator Site
state: Indiana
city: Plainfield
country: United States
facility: Investigator Site
state: Indiana
city: Olathe
country: United States
facility: Investigator Site
state: Kansas
city: Wichita
country: United States
facility: Investigator Site
state: Kansas
city: Omaha
country: United States
facility: Investigator Site
state: Nebraska
city: Henderson
country: United States
facility: Investigator Site
state: Nevada
city: Cary
country: United States
facility: Investigator Site
state: North Carolina
city: Hickory
country: United States
facility: Investigator Site
state: North Carolina
city: High Point
country: United States
facility: Investigator Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Investigator Site
state: North Carolina
city: Simpsonville
country: United States
facility: Investigator Site
state: South Carolina
city: Murfreesboro
country: United States
facility: Investigator Site
state: Tennessee
city: College Station
country: United States
facility: Investigator Site
state: Texas
city: Tyler
country: United States
facility: Investigator Site
state: Texas
Study officials:
References: