Clinical Trial: Follow-up Study to Evaluate Sustained Clearance Rates of Actinic Keratoses up to One Year

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: 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

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 Summary:

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


Sponsor: Graceway Pharmaceuticals, LLC

Current Primary Outcome: Number of Participants With Recurrence of AK Lesions [ Time Frame: 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.


Original Primary Outcome: Recurrence of AK lesions [ Time Frame: Up to one year ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Graceway Pharmaceuticals, LLC

Dates:
Date Received: April 24, 2008
Date Started: April 2008
Date Completion:
Last Updated: July 13, 2010
Last Verified: July 2010