Status:
COMPLETED
Follow-up Study to Evaluate Sustained Clearance Rates of Actinic Keratoses up to One Year
Lead Sponsor:
Graceway Pharmaceuticals, LLC
Conditions:
Actinic Keratoses
Eligibility:
All Genders
18+ years
Brief Summary
The objective of this study was to obtain long-term sustained clearance rates for subjects previously treated with imiquimod creams in studies GW01-0702, GW01-0703, GW01-0704 and GW01-0705.
Detailed Description
This is a Phase 3 longitudinal and observational study. Subjects who previously enrolled in studies GW01-0702, GW01-0703, GW01-0704, and GW01-0705 and were completely cleared of their AK lesions in th...
Eligibility Criteria
Inclusion
- Are willing and able to give informed consent;
- Have successfully completed one of the following studies: GW01-0702, GW01- 0703, GW01-0704, or GW01-0705 and have been determined to be completely clear of AK lesions at the EOS visit in the designated treatment area from the previous study
- Are willing to participate in the study as an outpatient, make visits to the study center for follow-up evaluation, and agree to comply with all study requirements.
Exclusion
- None. All subjects who meet the inclusion criteria above may participate.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT00668733
Start Date
April 1 2008
End Date
July 1 2009
Last Update
July 20 2010
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