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)

NCT01516515 Phase 2 COMPLETED

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).

Details

Lead sponsor	G&E Herbal Biotechnology Co., LTD
Phase	Phase 2
Status	COMPLETED
Enrolment	86
Start date	2013-02
Completion	2018-10

Conditions

• Actinic Keratosis

Interventions

• Vehicle gel
• SR-T100 with 2.3% of SM

Primary outcomes

• Total clearance rate: — 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) .

Countries

United States