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

Actinic Keratosis Clinical Trial

Official title:

A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis of the Face or Balding Scalp

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01686152
• Other study ID #: SYM 2012-01
• Status: Completed
• Phase: Phase 3
• Start date: September 2012
• Est. completion date: August 2013

Study information

• Verified date: November 2020
• Source: Teva Pharmaceuticals USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 589
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• Imiquimod Cream, 3.75%

• Zyclara®

Other:
• Vehicle of Test Product

Locations

Country	Name	City	State
United States	Altman Dermatology Associates	Arlington Heights	Illinois
United States	Visions Clinical Research	Boynton Beach	Florida
United States	Radiant Research, Inc.	Cincinnati	Ohio
United States	Tampa Bay Medical Research	Clearwater	Florida
United States	Research Across America	Dallas	Texas
United States	Encino Research Center	Encino	California
United States	Philadelphia Institute of Dermatology	Fort Washington	Pennsylvania
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Longmont Clinic, PC	Longmont	Colorado
United States	Dermatology Research Associates	Los Angeles	California
United States	Dermatology Specialists Research LLC	Louisville	Kentucky
United States	International Dermatology Research, Inc.	Miami	Florida
United States	MedaPhase, Inc.	Newnan	Georgia
United States	Tory Sullivan, M.D., P.A.	North Miami Beach	Florida
United States	Park Avenue Dermatology, PA	Orange Park	Florida
United States	Leavitt Medical Associates of Florida dba Ameriderm Research	Ormond Beach	Florida
United States	Radiant Research, Inc.	Pinellas Park	Florida
United States	The Indiana Clinical Trials Center	Plainfield	Indiana
United States	Oregon Medical Research Center, PC	Portland	Oregon
United States	Northern California Research	Sacramento	California
United States	Skin Surgery Medical Group, Inc.	San Diego	California
United States	Radiant Research, Inc.	Tucson	Arizona
United States	Omega Medical Research	Warwick	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Teva Pharmaceuticals USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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