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Safety and Effectiveness Study of Imiquimod Creams for the Treatment of Actinic Keratoses (AKs)

Information source: Graceway Pharmaceuticals, LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Actinic Keratosis

Intervention: Imiquimod cream (Drug); Placebo cream (Drug); Imiquimod cream (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Graceway Pharmaceuticals, LLC

Official(s) and/or principal investigator(s):
Sharon F Levy, MD, Study Director, Affiliation: Graceway Pharmaceuticals

Summary

The purpose of this study is to determine whether imiquimod creams are effective in treating Actinic Keratoses when applied to the face or balding scalp. Actinic keratosis (AK) is a skin condition that shows up on skin routinely exposed to the sun, such as the face, scalp, shoulders, chest, back, arms, and hands. The active ingredient contained in the study cream for this study is the same as that of the approved product Aldara, which has shown to be safe and effective for the treatment of AKs.

Clinical Details

Official title: A Phase 3, Randomized, Double-blinded, Placebo-controlled, Multicenter, Efficacy and Safety Study of Six Weeks of Treatment With Imiquimod Creams for Actinic Keratoses

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Number of Participants With Complete Clearance of AK Lesions

Secondary outcome:

Number of Participants With Partial Clearance of AK Lesions

Percent Change From Baseline in AK Lesion Count

Local Skin Reactions (LSR)

Detailed description: These were a randomized, double-blind, multicenter, placebo-controlled studies that compared the efficacy and safety of 2. 5% imiquimod cream and 3. 75% imiquimod cream with that of placebo in the treatment of typical visible or palpable AK of the face or balding scalp. Subjects were scheduled for a total of 11 visits (1 prestudy screening visit and 10 on-study visits). Subjects determined to be eligible during the screening phase were randomized in a 1: 1:1 ratio to 2. 5% imiquimod cream, 3. 75% imiquimod cream, or placebo cream. The creams were applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment. The investigator selected the treatment area for the study (either the entire face or the entire balding scalp, but not both). Subjects applied a thin layer of cream to the treatment area (up to 2 packets, or 500 mg of product, per application), avoiding the periocular areas, lips, and nares. Study medication was applied prior to normal sleeping hours and removed approximately 8 hours later with mild soap and water. Ears were excluded from both assessment and treatment. Rest periods from daily treatment were instituted by the investigator as needed to manage local skin reactions (LSRs) or application site reactions, with resumption of treatment upon adequate resolution as determined by the investigator. The duration of each subject's study participation was approximately 21 weeks, including a 4-week maximum screening period and a 17-week study period. At the End of Study (EOS) visit, eligible subjects may have been invited to participate in a separate study evaluating AK recurrence.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- In good general health.

- Have 5 to 20 AKs on the face or balding scalp.

- Negative pregnancy test (for women who are able to become pregnant).

- Willing to make frequent visits to the study center during the treatment and

follow-up periods. Exclusion Criteria:

- Women who are pregnant, lactating or planning to become pregnant during the study.

- Have had a medical event within 90 days of the first visit (such as: stroke, heart

attack).

- Have any skin condition in the treatment area that may be made worse by treatment

with imiquimod (such as: rosacea, psoriasis, atopic dermatitis, eczema).

- Have received specific treatments/medications in the treatment area(s) within the

designated time period prior to study treatment initiation.

Locations and Contacts

Birmingham, Alabama 35205, United States

Little Rock, Arkansas 72205, United States

Encino, California 91436, United States

Vista, California 92083, United States

New Britain, Connecticut 06052, United States

New Haven, Connecticut 06511, United States

Coral Gables, Florida 33134, United States

West Palm Beach, Florida 33401, United States

Arlington Heights, Illinois 60005, United States

Champaign, Illinois 61820, United States

Carmel, Indiana 46032, United States

Evansville, Indiana 47713, United States

South bend, Indiana 46617, United States

Louisville, Kentucky 40202, United States

Omaha, Nebraska 68144, United States

Reno, Nevada 89509, United States

Albuquerque, New Mexico 87106, United States

Portland, Oregon 97223, United States

Philadelphia, Pennsylvania 19034, United States

Nashville, Tennessee 37203, United States

Dallas, Texas 75246, United States

Houston, Texas 77030, United States

Houston, Texas 77058, United States

San Antonio, Texas 78229, United States

Norfolk, Virginia 23507, United States

Woodbridge, Virginia 22191, United States

Additional Information

Related publications:

Hanke CW, Beer KR, Stockfleth E, Wu J, Rosen T, Levy S. Imiquimod 2.5% and 3.75% for the treatment of actinic keratoses: results of two placebo-controlled studies of daily application to the face and balding scalp for two 3-week cycles. J Am Acad Dermatol. 2010 Apr;62(4):573-81. doi: 10.1016/j.jaad.2009.06.020. Epub 2010 Feb 4.

Starting date: January 2008
Last updated: June 22, 2010

Page last updated: August 23, 2015

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