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 LesionsPercent 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
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