Open-Label Safety Study to Evaluate Imiquimod Cream, 5% for Large Areas of Actinic Keratosis
NCT ID: NCT00116649
Last Updated: 2010-07-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
551 participants
INTERVENTIONAL
2005-06-30
2007-05-31
Brief Summary
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Detailed Description
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This study assessed the safety of imiquimod as a treatment for AK 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, depending upon treatment success and AK lesion recurrence. Eligible subjects applied imiquimod 5% cream prior to normal sleeping hours 2 days per week to at least 4 clinically typical, visible, discrete, nonhypertrophic AK lesions in contiguous or noncontiguous treatment areas totaling greater than 25 cm2 at baseline. Multiple treatment areas could be exposed (i.e., head, torso and/or extremities), with the number of packets determined by the investigator but not to exceed one packet for each 25 cm2 treatment area, up to a maximum of 6 packets per dose. In each treatment cycle, dosing was to continue for 16 weeks (approximately 4 months), as instructed by the investigator, followed by a 2-month, treatment-free follow-up period.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Aldara 5%
Aldara® (imiquimod) cream, 5% supplied in 250 mg single-use packets.
imiquimod cream
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
Interventions
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imiquimod cream
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have greater than 25 cm2 total treatment area(s) containing at least 4 actinic keratosis lesions.
Exclusion Criteria
* Have received specific treatments/medications in the treatment area(s) within the designated time period prior to study treatment initiation.
18 Years
ALL
No
Sponsors
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Graceway Pharmaceuticals, LLC
INDUSTRY
Responsible Party
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Graceway Pharmaceuticals
Principal Investigators
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Sharon Levy, MD
Role: STUDY_DIRECTOR
Graceway Pharmaceuticals
Locations
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Phoenix, Arizona, United States
Encino, California, United States
Los Angeles, California, United States
Riverside, California, United States
San Diego, California, United States
Santa Monica, California, United States
Denver, Colorado, United States
New Britain, Connecticut, United States
Coral Gables, Florida, United States
Hollywood, Florida, United States
Miami, Florida, United States
West Palm Beach, Florida, United States
Arlington Heights, Illinois, United States
Indianapolis, Indiana, United States
Metairie, Louisiana, United States
Boston, Massachusetts, United States
Chaska, Minnesota, United States
Henderson, Nevada, United States
Henderson, Nevada, United States
Reno, Nevada, United States
Reno, Nevada, United States
New York, New York, United States
High Point, North Carolina, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
Portland, Oregon, United States
Flourtown, Pennsylvania, United States
Arlington, Texas, United States
San Antonio, Texas, United States
Woodbridge, Virginia, United States
Spokane, Washington, United States
Milwaukee, Wisconsin, United States
Countries
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References
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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.
Other Identifiers
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1520-IMIQ
Identifier Type: -
Identifier Source: org_study_id
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