Open-Label Safety Study to Evaluate Imiquimod Cream, 5% for Large Areas of Actinic Keratosis
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|ClinicalTrials.gov Identifier: NCT00116649|
Recruitment Status : Completed
First Posted : July 1, 2005
Results First Posted : November 25, 2008
Last Update Posted : July 20, 2010
|Condition or disease||Intervention/treatment||Phase|
|Keratosis||Drug: imiquimod cream||Phase 4|
This was a Phase 4, open-label, single-arm, multicenter study in male and female subjects aged 18 years or older with clinically diagnosed AK lesions, conducted at 31 investigational sites in the United States.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||551 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||June 2005|
|Primary Completion Date :||May 2007|
|Study Completion Date :||May 2007|
Experimental: Aldara 5%
Aldara® (imiquimod) cream, 5% supplied in 250 mg single-use packets.
Drug: 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 Name: Aldara® (imiquimod) cream 5%
- Number of Participants Who Experienced an Adverse Event [ Time Frame: from first dose up to 18 months ]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.
- Percent Reduction From Baseline to the Final Follow-up in Total Actinic Keratosis Lesion Count [ Time Frame: At Month 18 ]Percent reduction = (total baseline AK lesion count - total final lesion count)x100/ total baseline AK lesion count
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00116649
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|Study Director:||Sharon Levy, MD||Graceway Pharmaceuticals|