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Safety and Effectiveness Study of Imiquimod Creams for 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 Keratoses

Intervention: imiquimod cream (Drug); imiquimod cream (Drug); Placebo (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 been 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 Four 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, Caregiver, 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

Detailed description: This was a randomized, double-blind, multicenter, placebo-controlled study 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 AKs of the face or balding scalp. Subjects were scheduled for a total of 9 visits (1 prestudy screening visit and 8 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 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 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 18 weeks, including a 4-week maximum screening period and a 14-week study period.

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 urine pregnancy test (for women who are able to become pregnant)

- Willing to make frequent visits to the study center during 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 (e. g., 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

Fremont, California 94538, United States

Los Angeles, California 90045, United States

Riverside, California 92506, United States

San Diego, California 92117, United States

Vallejo, California 94589, United States

Miami, Florida 33144, United States

Newman, Georgia 30263, United States

Boise, Idaho 83704, United States

Springfield, Illinois 62703, United States

Dubuque, Iowa 52002, United States

Olathe, Kansas 66061, United States

Wichita, Kansas 67206, United States

Marrero, Louisiana 70072, United States

Henderson, Nevada 89052, United States

Rochester, New York 14623, United States

High Point, North Carolina 27262, United States

Winston Salem, North Carolina 27106, United States

Portland, Oregon 97239, United States

Nashville, Tennessee 37215, United States

Austin, Texas 78759, United States

Dallas, Texas 75230, United States

Houston, Texas 77056, United States

San Antonio, Texas 78229, United States

Salt Lake City, Utah 84124, United States

West Jordan, Utah 84088, United States

Lynchburg, Virginia 24501, United States

Additional Information

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

Page last updated: August 23, 2015

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