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

Graceway Pharmaceuticals, LLC179 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

179

Conditions

Actinic Keratoses

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Up to one year

Data from ClinicalTrials.gov

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