Safety and Effectiveness Study of Imiquimod Creams for the Treatment of Actinic Keratoses (AKs)
A Phase 3, Randomized, Double-blinded, Placebo-controlled, Multicenter, Efficacy and Safety Study of Six Weeks of Treatment With Imiquimod Creams for Actinic Keratoses
1 other identifier
interventional
490
1 country
26
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2008
Shorter than P25 for phase_3
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 16, 2008
CompletedFirst Posted
Study publicly available on registry
January 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedResults Posted
Study results publicly available
June 22, 2010
CompletedJune 29, 2010
June 1, 2010
6 months
January 16, 2008
April 15, 2010
June 22, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Complete Clearance of AK Lesions
Subject status with respect to complete clearance of AK lesions at End of Study (EOS), ie, the Week 17 visit. Complete clearance was defined as the absence of clinically visible or palpable AK lesions in the treatment area. All lesions within the identified treatment area were included in the count, even if the lesion was a new lesion or "subclinical" lesion that had not been identified at Baseline.
End of Study the Week 17 visit
Secondary Outcomes (3)
Number of Participants With Partial Clearance of AK Lesions
End of Study the Week 17 visit
Percent Change From Baseline in AK Lesion Count
At all visits - Baseline through the Week 17 EOS visit
Local Skin Reactions (LSR)
The time period for the AUC extends to 8 weeks after the end of treatment (Week 17)
Study Arms (3)
3.75% imiquimod cream
ACTIVE COMPARATOR2.5% imiquimod cream
ACTIVE COMPARATORPlacebo cream
PLACEBO COMPARATORInterventions
250 mg/packet, up to 2 packets 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.
250 mg/packet, up to 2 packets 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Unknown Facility
Birmingham, Alabama, 35205, United States
Unknown Facility
Little Rock, Arkansas, 72205, United States
Unknown Facility
Encino, California, 91436, United States
Unknown Facility
Vista, California, 92083, United States
Unknown Facility
New Britain, Connecticut, 06052, United States
Unknown Facility
New Haven, Connecticut, 06511, United States
Unknown Facility
Coral Gables, Florida, 33134, United States
Unknown Facility
West Palm Beach, Florida, 33401, United States
Unknown Facility
Arlington Heights, Illinois, 60005, United States
Unknown Facility
Champaign, Illinois, 61820, United States
Unknown Facility
Carmel, Indiana, 46032, United States
Unknown Facility
Evansville, Indiana, 47713, United States
Unknown Facility
South Bend, Indiana, 46617, United States
Unknown Facility
Louisville, Kentucky, 40202, United States
Unknown Facility
Omaha, Nebraska, 68144, United States
Unknown Facility
Reno, Nevada, 89509, United States
Unknown Facility
Albuquerque, New Mexico, 87106, United States
Unknown Facility
Portland, Oregon, 97223, United States
Unknown Facility
Philadelphia, Pennsylvania, 19034, United States
Unknown Facility
Nashville, Tennessee, 37203, United States
Unknown Facility
Dallas, Texas, 75246, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
Houston, Texas, 77058, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Norfolk, Virginia, 23507, United States
Unknown Facility
Woodbridge, Virginia, 22191, United States
Related Publications (1)
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.
PMID: 20133012BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sharon F Levy, MD
- Organization
- Graceway Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Sharon F Levy, MD
Graceway Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 16, 2008
First Posted
January 29, 2008
Study Start
January 1, 2008
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
June 29, 2010
Results First Posted
June 22, 2010
Record last verified: 2010-06