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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

Page last updated: August 23, 2015

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