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”

The objective of this study is 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.

Study Type: Observational

Study Design: Cohort, Prospective

Study Primary Completion Date: August 2009

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.

Primary Measures

• Recurrence of AK lesions
  • Time Frame: Up to one year
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Graceway Pharmaceuticals, LLC

Overall Clinical Trial Officials and Contacts

Sharon Levy, MD Study Director Graceway Pharmaceuticals, LLC  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00668733

Study ID Number: GW01-0803

ClinicalTrials.gov Identifier: NCT00668733

Health Authority: United States: Food and Drug Administration