Follow-up Study to Evaluate Sustained Clearance Rates of Actinic Keratoses up to One Year After Completion of Studies GW01-0702, GW01-0703, GW01-0704, and GW01-0705
18 Years
N/A
Both
Actinic Keratoses
Trial Information
Follow-up Study to Evaluate Sustained Clearance Rates of Actinic Keratoses up to One Year After Completion of Studies GW01-0702, GW01-0703, GW01-0704, and GW01-0705
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
Inclusion Criteria:
- 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 Criteria:
- None. All subjects who meet the inclusion criteria above may participate.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Number of Participants With Recurrence of AK Lesions
Outcome Description:
The primary efficacy variable in this study was the absence of AK lesions(sustained clearance rate) in the previously treated area.
Outcome Time Frame:
Up to one year
Safety Issue:
No
Principal Investigator
Sharon Levy, MD
Investigator Role:
Study Director
Investigator Affiliation:
Graceway Pharmaceuticals, LLC
Authority:
United States: Food and Drug Administration
Study ID:
GW01-0803
NCT ID:
NCT00668733
Start Date:
April 2008
Completion Date:
July 2009
Related Keywords:
- Actinic Keratoses
- Actinic keratoses
- Dermatologic disease
- Keratosis
- Keratosis, Actinic
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