Safety and Effectiveness Study of Imiquimod Creams for Treatment of Actinic Keratoses (AKs)
A Phase 3, Randomized, Double-blinded, Placebo-controlled, Multicenter, Efficacy and Safety Study of Four Weeks of Treatment With Imiquimod Creams for Actinic Keratoses
1 other identifier
interventional
479
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 been 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 30, 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 14 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 14 visit
Secondary Outcomes (3)
Number of Participants With Partial Clearance of AK Lesions
End of Study the Week 14 visit
Percent Change From Baseline in AK Lesion Count
From baseline to End of Study the Week 14 visit
Local Skin Reactions
At all visits - from Baseline to End of study (Week 14)
Study Arms (3)
3.75% imiquimod cream
ACTIVE COMPARATOR2.5% imiquimod cream
ACTIVE COMPARATORPlacebo cream
PLACEBO COMPARATORInterventions
cream, 250 mg/packet, up to 2 packets 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.
cream, 250 mg/packet, up to 2 packets 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.
Eligibility Criteria
You may qualify if:
- 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.
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 (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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Unknown Facility
Fremont, California, 94538, United States
Unknown Facility
Los Angeles, California, 90045, United States
Unknown Facility
Riverside, California, 92506, United States
Unknown Facility
San Diego, California, 92117, United States
Unknown Facility
Vallejo, California, 94589, United States
Unknown Facility
Miami, Florida, 33144, United States
Unknown Facility
Newnan, Georgia, 30263, United States
Unknown Facility
Boise, Idaho, 83704, United States
Unknown Facility
Springfield, Illinois, 62703, United States
Unknown Facility
Dubuque, Iowa, 52002, United States
Unknown Facility
Olathe, Kansas, 66061, United States
Unknown Facility
Wichita, Kansas, 67206, United States
Unknown Facility
Marrero, Louisiana, 70072, United States
Unknown Facility
Henderson, Nevada, 89052, United States
Unknown Facility
Rochester, New York, 14623, United States
Unknown Facility
High Point, North Carolina, 27262, United States
Unknown Facility
Winston-Salem, North Carolina, 27106, United States
Unknown Facility
Portland, Oregon, 97239, United States
Unknown Facility
Nashville, Tennessee, 37215, United States
Unknown Facility
Austin, Texas, 78759, United States
Unknown Facility
Dallas, Texas, 75230, United States
Unknown Facility
Houston, Texas, 77056, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Salt Lake City, Utah, 84124, United States
Unknown Facility
West Jordan, Utah, 84088, United States
Unknown Facility
Lynchburg, Virginia, 24501, United States
Related Publications (1)
Swanson N, Abramovits W, Berman B, Kulp J, Rigel DS, 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 2-week cycles. J Am Acad Dermatol. 2010 Apr;62(4):582-90. doi: 10.1016/j.jaad.2009.07.004. Epub 2010 Feb 4.
PMID: 20133013RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sharon F. Levy, MD
- Organization
- Graceway Pharmaceuticals LLC
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
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 16, 2008
First Posted
January 30, 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