Clinical Trial: Efficacy and Safety Phase II Study of SR-T100 to Treat Actinic Keratosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Double-blind, Randomized, Vehicle-controlled, Parallel-group, Phase II Study to Evaluate the Efficacy and Safety of SR-T100 Gel in Patients With Actinic Keratosis (AK)

Brief Summary: This Phase II study is to evaluate the efficacy of SR-T100 gel with 2.3% of SM in Solanum undatum plant extract in patient with Actinic Keratosis (AK).

Detailed Summary:
Sponsor: G&E Herbal Biotechnology Co., LTD

Current Primary Outcome: Total clearance rate: [ Time Frame: 8-week post-EOT visit (scheduled at Week 24 visit) ]

The proportion of patients achieving total clearance of AK lesions in the treatment area (in total of 25cm2 area) at 8-week post-EOT visit (scheduled at Week 24 visit) .


Original Primary Outcome: Same as current

Current Secondary Outcome: Partial clearance rate [ Time Frame: 24 week ]

The proportion of patients achieving ≥ 75% total clinically assessed AK lesion counts out of all target lesions in the treatment area (in total of 25cm2 area) at the post-EOT visit (8 weeks after EOT visit).


Original Secondary Outcome: Same as current

Information By: G&E Herbal Biotechnology Co., LTD

Dates:
Date Received: January 17, 2012
Date Started: February 2013
Date Completion: December 2016
Last Updated: February 17, 2016
Last Verified: February 2016