Open-Label Safety Study to Evaluate Imiquimod Cream, 5% for Large Areas of Actinic Keratosis
Open-Label Safety and Pharmacokinetic Study of AldaraTM (Imiquimod) Cream, 5% for One, Two, or Three Treatment Cycles to Surface Areas Greater Than 25 cm2 With Actinic Keratosis
1 other identifier
interventional
551
1 country
32
Brief Summary
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 purpose of this study is to evaluate the safety of one, two, or three cycles of imiquimod for the treatment of AK. The AK lesions treated can be in adjacent and nonadjacent areas of the head, torso, and extremities. The total surface area for the AK lesions must be greater than 25 cm2. The secondary objective is to evaluate the effectiveness of treatment with imiquimod in people with large surface areas of AK.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2005
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 30, 2005
CompletedFirst Posted
Study publicly available on registry
July 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedResults Posted
Study results publicly available
November 25, 2008
CompletedJuly 20, 2010
July 1, 2010
1.9 years
June 30, 2005
October 21, 2008
July 14, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Who Experienced an Adverse Event
Adverse events that occurred between the first day of exposure to the study cream and study discharge were summarized. Adverse events - any untoward medical occurrence in a subject that is temporally related to protocol procedures, including the administration of a pharmaceutical product at any dose, but which does not necessarily have a causal relationship with the treatment.
from first dose up to 18 months
Secondary Outcomes (1)
Percent Reduction From Baseline to the Final Follow-up in Total Actinic Keratosis Lesion Count
At Month 18
Study Arms (1)
Aldara 5%
EXPERIMENTALAldara® (imiquimod) cream, 5% supplied in 250 mg single-use packets.
Interventions
imiquimod 5% cream applied in doses ranging from one packet (12.5 mg) to 6 packets (75 mg) to either single or multiple body regions for up to 3 cycles
Eligibility Criteria
You may qualify if:
- Are at least 18 years of age.
- Have greater than 25 cm2 total treatment area(s) containing at least 4 actinic keratosis lesions.
You may not qualify if:
- 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 (32)
Unknown Facility
Phoenix, Arizona, 85044, United States
Unknown Facility
Encino, California, 91436, 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
Santa Monica, California, 90404, United States
Unknown Facility
Denver, Colorado, 80210, United States
Unknown Facility
New Britain, Connecticut, 06052, United States
Unknown Facility
Coral Gables, Florida, 33134, United States
Unknown Facility
Hollywood, Florida, 33021, United States
Unknown Facility
Miami, Florida, 33175, United States
Unknown Facility
West Palm Beach, Florida, 33401, United States
Unknown Facility
Arlington Heights, Illinois, 60005, United States
Unknown Facility
Indianapolis, Indiana, 46256, United States
Unknown Facility
Metairie, Louisiana, 70006, United States
Unknown Facility
Boston, Massachusetts, 02118, United States
Unknown Facility
Chaska, Minnesota, 55318, United States
Unknown Facility
Henderson, Nevada, 89014, United States
Unknown Facility
Henderson, Nevada, 89052, United States
Unknown Facility
Reno, Nevada, 89509, United States
Unknown Facility
Reno, Nevada, 89521, United States
Unknown Facility
New York, New York, 10021, United States
Unknown Facility
High Point, North Carolina, 27262, United States
Unknown Facility
Raleigh, North Carolina, 27612, United States
Unknown Facility
Winston-Salem, North Carolina, 27106, United States
Unknown Facility
Portland, Oregon, 97210, United States
Unknown Facility
Flourtown, Pennsylvania, 19031, United States
Unknown Facility
Arlington, Texas, 76011, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Woodbridge, Virginia, 22191, United States
Unknown Facility
Spokane, Washington, 99204, United States
Unknown Facility
Milwaukee, Wisconsin, 53207, United States
Related Publications (1)
Del Rosso JQ, Sofen H, Leshin B, Meng T, Kulp J, Levy S. Safety and Efficacy of Multiple 16-week Courses of Topical Imiquimod for the Treatment of Large Areas of Skin Involved with Actinic Keratoses. J Clin Aesthet Dermatol. 2009 Apr;2(4):20-8.
PMID: 20729935RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sharon Levy, MD VP Product Development
- Organization
- Graceway Pharmaceuticals LLC
Study Officials
- STUDY DIRECTOR
Sharon Levy, MD
Graceway Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 30, 2005
First Posted
July 1, 2005
Study Start
June 1, 2005
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
July 20, 2010
Results First Posted
November 25, 2008
Record last verified: 2010-07