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 LesionsPercent 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
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