Bioequivalence Study of Two Imiquimod Cream 5%
Information source: Taro Pharmaceuticals USA
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Actinic Keratosis
Intervention: Imiquimod 5% manufactured by Taro (Drug); Aldara - Imiquimod 5% (Drug); Imiquimod Vehicle manufactured by Taro (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Taro Pharmaceuticals USA
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Number of Participants With 100% Clearance of Actinic Keratosis Lesions: Comparison of Taro Imiquimod 5% and Aldara-Imiquimod 5%Number of Participants in Intention-to-treat (ITT)Population With 100% Clearance of Actinic Keratosis (AK) Lesions Identified at Baseline
Secondary outcome: Patients Reporting at Least One Adverse Event
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Investigator Site, Gilbert, Arizona, United States
Investigator Site, Tempe, Arizona, United States
Investigator Site, Tuscon, Arizona, United States
Investigator Site, Denver, Colorado, United States
Investigator Site, Jacksonville, Florida, United States
Investigator Site, Miami, Florida, United States
Investigator Site, Evansvill, Indiana, United States
Investigator Site, Plainfield, Indiana, United States
Investigator Site, Olathe, Kansas, United States
Investigator Site, Wichita, Kansas, United States
Investigator Site, Omaha, Nebraska, United States
Investigator Site, Henderson, Nevada, United States
Investigator Site, 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, Simpsonville, South Carolina, United States
Investigator Site, Murfreesboro, Tennessee, United States
Investigator Site, College Station, Texas, United States
Investigator Site, Tyler, Texas, United States
Additional Information
Starting date: June 2008
Last updated: December 21, 2013
|