Efficacy Study & Safety Evaluation of SR-T100 Gel in Actinic Keratosis Treatment
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|