Efficacy Study & Safety Evaluation of SR-T100 Gel in Actinic Keratosis Treatment
|ClinicalTrials.gov Identifier: NCT01493921|
Recruitment Status : Completed
First Posted : December 16, 2011
Last Update Posted : February 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Actinic Keratosis||Drug: SR-T100 gel Drug: Vehicle gel||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||113 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized, Double-Blind, Parallel, Vehicle-Controlled Phase III Trial to Assess the Efficacy and Safety of Topical SR-T100 Gel in the Treatment of Patients With Actinic Keratosis|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
Experimental: SR-T100 gel
Patient group receiving medication SR-T100 gel with active ingredient under investigation, enrolled subjects randomly assigned to this group to accurately depict statistical significance of the measured outcome.
Drug: SR-T100 gel
Patient will be instructed to self-apply approximately 0.3~0.5g of SR-T100 gel on 25 cm squared treatment area (avoiding the periocular areas, lips, and nares) once daily with an occlusive dressing for 16 weeks treatment period.
Active Comparator: Vehicle gel
Patients given placebo with non-SR-T100 ingredients as they are being administered to patients, subjects are under random assignments from patient pool to depict statistically significant outcome measurement.
Drug: Vehicle gel
Patient wil be instructed to self-apply approximately 0.3~0.5g of vehicle gel (without active ingredient)per total of 25 cm squared treatment area (avoiding the periocular areas, lips, and nares) once daily with an occlusive dressing for 16 weeks treatment period.
- Comparison of SR-T100 gel effect with those of vehicle gel (Placebo) on efficacy and tolerability in patients with actinic keratosis [ Time Frame: 24 weeks ]The primary objective is to compare the complete clearance rate between treatment groups at 8 weeks after the completion of 16 weeks study treatment. The primary efficacy endpoint is to evaluate the complete clearance rate at 8 weeks after the completion of 16 weeks study treatment between treatment groups. The complete clearance is defined as the absence of visible or palpable AK lesions in the treatment area
- Evaluation of efficacy and tolerability of SR-T100 gel in AK treatment [ Time Frame: 24 weeks ]SR-T100 clinical application in Actinic Keratosis treatment as direct proportional relationship to lesion size reduction, complete & partial clearance defined consequently as 100% & ≧75% reduction, coordinated toxicity & bio-safety reports supplements additional case study basis & foundation.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01493921
|Chiayi Chang Gung Memorial Hospital|
|Kaohsiung Chang Gung Memorial Hospital|
|Kaohsiung Medical University Chung-Ho Memorial Hospital|
|Kaohsiung Veterans General Hospital|
|Chi Mei Medical Center YongKang|
|National Cheng Kung University Hospital|
|Principal Investigator:||Hamm-Ming Sheu, MD||National Cheng-Kung University Hospital|