Bioequivalence of Generic Imiquimod Cream, 5% When Compared to Aldara™ (Imiquimod) Cream, 5% in the Treatment of Actinic Keratosis

NCT00948428 | Completed Phase 3 Results

• 1 other identifier: D94-3101-07
• Study Type: interventional
• Target: 462
• Locations: 1 country
• Sites: 20

Brief Summary

At the end of the study, safety and efficacy outcome measures will be compared to determine a) if dosing with Generic Imiquimod cream, 5% is therapeutically equivalent to the currently marketed Aldara (imiquimod) cream, 5% and b) if both imiquimod 5% creams are superior in comparison to the Vehicle cream.

Conditions

Actinic Keratoses

Keywords

actinic keratoses; imiquimod; therapeutic equivalence; bioequivalence

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects in Each Treatment Group With Complete Clearance of AK Lesions at the Test of Cure Visit (Week 24)

  Week 24

Secondary Outcomes (2)

• Percentage of Subjects With at Least a 75% Reduction in the Number of AK Lesions From Baseline to End of Treatment (EOT) Visit (Week 16).

  Week 16

• Percentage of Subjects With at Least a 75% Reduction in the Number of AK Lesions From Baseline to 8 Weeks Post Treatment (Test of Cure Visit).

  Week 24

Study Arms (3)

Generic Imiquimod

ACTIVE COMPARATOR

imiquimod cream, 5%

Drug: imiquimod

Aldara™

ACTIVE COMPARATOR

Aldara™ (imiquimod) cream, 5%

Drug: Aldara™

Vehicle cream

PLACEBO COMPARATOR

Vehicle cream (Actavis)

Drug: Vehicle Cream

Interventions

imiquimod DRUG

5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks

Generic Imiquimod

Aldara™ DRUG

5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks

Aldara™

Vehicle Cream DRUG

Topical cream vehicle matching Generic imiquimod dispensed in individual 0.25 g sachets applied twice a week for 16 weeks

Vehicle cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects were male or non-pregnant females, 18 years of age or older, in generally good health. Females who were post-menopausal, surgically sterile or using a medically acceptable form of birth control with a negative urine pregnancy test at the Baseline visit.
• Subjects provided written and verbal informed consent.
• Subjects presented to the clinic with at least 4 but no more than 12 visible, discrete nonhyperkeratotic, nonhypertrophic actinic keratosis lesions within a 25 cm2 Treatment Area on the face and/or anterior scalp.
• Subjects were willing and able to comply with study instructions and return to the clinic for required visits.

You may not qualify if:

• Subjects who were lactating, or planning to become pregnant during the study.
• Subjects had hyperkeratotic, hypertrophic or large mat-like AKs within the 25 cm2 Treatment Area.
• Subjects who had the need or were planning to be exposed to artificial tanning devices or excessive sunlight during the trial.
• Subjects who were immunosuppressed (e.g., HIV, systemic malignancy, graft vs. host disease, etc.).
• Subjects who experienced an unsuccessful outcome from previous imiquimod therapy.
• Subjects with known hypersensitivity or previous allergic reaction to any of the active or inactive components of the study drugs.
• Within 2 months: Facial and/or Anterior Scalp: laser resurfacing, photodynamic therapy, chemical peels, dermabrasion, topical application of 5-FU, imiquimod, diclofenac sodium or other treatments for AK or photodamage.
• Subjects who used the following systemic, oral or topical therapies for the periods specified prior to entry into the study:
• Within 2 days: Topicals of any kind to the selected Treatment Area. Within 2 weeks: Facial topical medications: corticosteroids, alpha- hydroxyacids (e.g., glycolic acid, lactic acid, etc. greater than 5%), beta-hydroxyacid (salicylic acid greater than 2%), urea - greater than 5% or prescription retinoids (e.g., tazarotene, adapalene, tretinoin) to the face and/or anterior scalp.
• Within 2 weeks: Cryotherapy to lesions adjacent to or within the 25 cm2 Treatment Area.
• Within 4 weeks: Systemic steroid therapy: chemotherapeutic agents, psoralens, immunotherapy, or retinoids.

Sponsors & Collaborators

• Actavis Inc.: lead

Study Sites (20)

Burke Pharmaceutical Research

Hot Springs, Arkansas, 71913, United States

Location

Associates in Research, Inc.

Fresno, California, 93720, United States

Location

Skin Surgery Medical Group, Inc.

San Diego, California, 92117, United States

Location

Cherry Creek Research, Inc.

Denver, Colorado, 80209, United States

Location

FXM Research Corp.

Miami, Florida, 33175, United States

Location

MedaPhase, Inc.

Newnan, Georgia, 30263, United States

Location

Deaconess Clinic, Inc.

Evansville, Indiana, 47713, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Mt. Sinai School of Medicine

New York, New York, 10029, United States

Location

Derm Research Center of New York, Inc.

Stony Brook, New York, 11790, United States

Location

University Dermatology Consultants, Inc.

Cincinnati, Ohio, 45219, United States

Location

Oregon Medical Research Center, P.C.

Portland, Oregon, 97223, United States

Location

Rhode Island Hospital, Dermatopharmacology Division

Providence, Rhode Island, 02903, United States

Location

Dermatology Associates of Knoxville, P.C.

Knoxville, Tennessee, 37917, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

DermResearch, Inc.

Austin, Texas, 78759, United States

Location

Suzanne Bruce & Associates, P.A.

Houston, Texas, 77056, United States

Location

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, 78229, United States

Location

Dermatology Research Center, Inc.

Salt Lake City, Utah, 84124, United States

Location

Premier Clinical Research

Spokane, Washington, 99204, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Imiquimod

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Senior Director, CE Studies
• Organization: Teva Pharmaceuticals USA, Inc.

USMedInfo@tevapharm.com

1-888-483-8279

Study Officials

• Christine M. Winslow, Ph.D.

  Actavis Mid-Atlantic LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2009
• First Posted: July 29, 2009
• Study Start: May 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: April 1, 2009
• Last Updated: September 4, 2020
• Results First Posted: September 4, 2020

Record last verified: 2020-09

Locations

US (20)