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

Actinic Keratoses Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00668733
• Other study ID #: GW01-0803
• Status: Completed
• Phase: N/A
• First received: April 24, 2008
• Last updated: July 13, 2010
• Start date: April 2008
• Est. completion date: July 2009

Study information

• Verified date: July 2010
• Source: Graceway Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Actinic Keratoses
• Keratosis
• Keratosis, Actinic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Graceway Pharmaceuticals, LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Recurrence of AK Lesions	The primary efficacy variable in this study was the absence of AK lesions(sustained clearance rate) in the previously treated area.	Up to one year	No