Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis

NCT01686152 | Completed Phase 3 Results

• 1 other identifier: SYM 2012-01
• Study Type: interventional
• Target: 589
• Locations: 1 country
• Sites: 23

Brief Summary

To determine the comparability of the safety and efficacy of Imiquimod Cream, 3.75% and Zyclara (imiquimod) Cream, 3.75% (the reference listed drug) in subjects with actinic keratosis (AK) of the face or balding scalp. It will also be determined whether the efficacy of each of the two active treatments is superior to that of the Vehicle cream.

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Success/Failure at Visit 5/Week 14

  The primary efficacy endpoint is the proportion of subjects with treatment success at Visit 5/Week 14 (8 weeks post-treatment). Treatment success is defined as 100% clearance of all AK lesions (baseline AK lesions and any new AK lesions) within the treatment area.

  14 Weeks

Study Arms (3)

Investigational Test Product

EXPERIMENTAL

Imiquimod Cream, 3.75% (Teva)

Drug: Imiquimod Cream, 3.75%

Reference Listed Drug

ACTIVE COMPARATOR

Zyclara® (imiquimod Cream), 3.75% (Medicis)

Drug: Zyclara®

Vehicle

PLACEBO COMPARATOR

Vehicle of Test Product (Teva)

Other: Vehicle of Test Product

Interventions

Imiquimod Cream, 3.75% DRUG

Investigational Test Product

Zyclara® DRUG

Also known as: Imiquimod Cream (generic name)

Reference Listed Drug

Vehicle of Test Product OTHER

Vehicle

Eligibility Criteria

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

You may qualify if:

• Willing and able to provide written informed consent for the study
• At least 18 years of age.
• Immunocompetent male or non-pregnant and non-lactating female. Each female subject of childbearing potential (excluding women who are surgically sterilized or postmenopausal for at least 2 years), in addition to having a negative urine pregnancy test at Visit 1/Day 1, must be willing to use an acceptable form of birth control during the study. For the purpose of this study, the following are considered acceptable methods of birth control: oral contraceptives, contraceptive patches, contraceptive implant, vaginal contraceptive, double-barrier methods (for example, condom and spermicide), contraceptive injection (Depo-Provera®), intrauterine device (IUD), hormonal IUD (Mirena®), and abstinence with a documented second acceptable method of birth control if the subject becomes sexually active. Subjects entering the study who are on hormonal contraceptives (oral contraceptives, patches and injection) must have been on this method for at least 3 months (90 days) prior to the study and continue the method for the duration of the study. Subjects who had used hormonal contraception (oral contraceptives, patches and injection) and stopped must have stopped no less than 3 months (90 days) prior to baseline. Subjects entering the study using contraceptive implants and intrauterine contraceptives must have been on this method for at least 6 months (180 days) and continue for the duration of the study and if they stopped must have stopped no less than 6 months (180 days) prior to baseline.
• Clinical diagnosis of AK, defined as ≥ 5 and ≤ 20 clinically typical, visible or palpable AK lesions, each at least 4 mm in diameter, in an area that exceeds 25 cm2 on either the face (excluding ears) or balding scalp, but not both face and scalp.
• In general good health and free from any clinically significant disease, other than AK, that might interfere with the study evaluations.
• Willing and able to understand and comply with the requirements of the study, apply the IP as instructed, attend the required visits, comply with therapy prohibitions, and be able to complete the study.

You may not qualify if:

• Presence of atopic dermatitis, basal cell carcinoma, eczema, psoriasis, rosacea, squamous cell carcinoma, or other possible confounding skin conditions on the treatment area of either the face or balding scalp.
• Clinically significant systemic disease (immunological deficiencies), unstable medical disorder, life-threatening disease, or current malignancies.
• Use on the face or balding scalp of chemical peel, dermabrasion, laser abrasion, psoralen plus ultraviolet A (PUVA) therapy, and/or ultraviolet B (UVB) therapy in the last 6 months (180 days)
• Use of any systemic cancer chemotherapy medications in the last 6 months (180 days)
• Use on the face or balding scalp of cryodestruction or chemodestruction, curettage, photodynamic therapy, surgical excision, topical 5-fluorouracil, topical corticosteroids, topical diclofenac, topical imiquimod, topical retinoids, masoprocol, or other treatments for AK in the last 1 month (30 days)
• Immunomodulators or immunosuppressive therapies, interferon, oral/systemic corticosteroids, or cytotoxic drugs in the last 1 month (30 days). Intranasal or inhaled corticosteroids are acceptable if kept constant throughout the study.
• Need or intent to continue to use any treatment listed in the four points above during the current study
• Known hypersensitivity or allergies to imiquimod or any component of the IP (in any dosage form).
• Females who are pregnant, breastfeeding, intending to become pregnant during the study, or who do not agree to use an acceptable form of birth control during the study.
• Any clinically significant condition or situation other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study.
• Use of any investigational drug or investigational device within 1 month (30 days) prior to randomization.
• Previous participation in this study.
• Sunburn in the designated treatment area to be treated at study entry.
• Current involvement in activities that require excessive or prolonged sun exposure.
• Consumption of excessive amounts of alcohol, abuse drugs.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (23)

Radiant Research, Inc.

Tucson, Arizona, 85710, United States

Location

Encino Research Center

Encino, California, 91436, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Northern California Research

Sacramento, California, 95821, United States

Location

Skin Surgery Medical Group, Inc.

San Diego, California, 92117, United States

Location

Longmont Clinic, PC

Longmont, Colorado, 80501, United States

Location

Visions Clinical Research

Boynton Beach, Florida, 33472, United States

Location

Tampa Bay Medical Research

Clearwater, Florida, 33761, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

International Dermatology Research, Inc.

Miami, Florida, 33144, United States

Location

Tory Sullivan, M.D., P.A.

North Miami Beach, Florida, 33162, United States

Location

Park Avenue Dermatology, PA

Orange Park, Florida, 32073, United States

Location

Leavitt Medical Associates of Florida dba Ameriderm Research

Ormond Beach, Florida, 32174, United States

Location

Radiant Research, Inc.

Pinellas Park, Florida, 33781, United States

Location

MedaPhase, Inc.

Newnan, Georgia, 30263, United States

Location

Altman Dermatology Associates

Arlington Heights, Illinois, 60005, United States

Location

The Indiana Clinical Trials Center

Plainfield, Indiana, 46168, United States

Location

Dermatology Specialists Research LLC

Louisville, Kentucky, 40202, United States

Location

Radiant Research, Inc.

Cincinnati, Ohio, 45249, United States

Location

Oregon Medical Research Center, PC

Portland, Oregon, 97223, United States

Location

Philadelphia Institute of Dermatology

Fort Washington, Pennsylvania, 19034, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Research Across America

Dallas, Texas, 75234, 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: Director, PD/CE Studies
• Organization: Teva Pharmaceuticals USA

usmedinfo@tevapharm.com

1-888-483-8279

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: September 12, 2012
• First Posted: September 17, 2012
• Study Start: September 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: November 24, 2020
• Results First Posted: October 30, 2020

Record last verified: 2020-11

Locations

US (23)