Follow-up Study to Evaluate Sustained Clearance Rates of Actinic Keratoses up to One Year
- Conditions
- Actinic Keratoses
- Registration Number
- NCT00668733
- Lead Sponsor
- Graceway Pharmaceuticals, LLC
- 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 the selected treatment area at the end-of-study visit will return for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
The NCT numbers for the above mentioned studies are:
NCT00603798 - for Studies GW01-0703 and GW01-0705
NCT00605176 for Studies GW01-0702 and GW01-0704
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 179
- 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.
- None. All subjects who meet the inclusion criteria above may participate.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants With Recurrence of AK Lesions Up to one year The primary efficacy variable in this study was the absence of AK lesions(sustained clearance rate) in the previously treated area.
- Secondary Outcome Measures
Name Time Method