Efficacy Study & Safety Evaluation of SR-T100 Gel in Actinic Keratosis Treatment
Studies of SR-T100 gel and its clinical relevance in the treatment of AK, providing adequate measured outcomes for skin lesion treatment. In addition to the high complete response rate (90.0%) as compared with the conventional therapy, the most significant result was that no undesirable side effects were associated with the use of SR-T100 gel. The result also shows approximately 80% of study subjects had a complete response in phase II clinical trial conducted in Taiwan; hence, result from our study model suggested SR-T100 gel offers beneficial therapeutic values in treatment of AK is harmless to the skin as well as high tolerance level displayed by majority of patients.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|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|
- 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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
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.
The primary objective of this study is to demonstrate a clinically significant outcome involving SR-T100 topical gel developed against skin lesions such as AK. Furthermore, evaluation of SR-T100 efficacy & tolerability in treating AK lesions are developed as secondary objective in this clinical study. Patients with at least two clinically visible, discrete, non-hyperkeratotic, non-hypertrophic AK lesions on the arms, shoulder, chest, face and or scalp and at least one lesion of greater than or equal to 4mm in diameter within a total of 25 cm squared contiguous or non-contiguous treatment are expected to be enrolled. Candidate pool is then divided into two groups with random assignments of treatment group or placebo group. This randomization scheme will be generated by biostatistics and produced by a computer software program that incorporates a standard procedure for generating random probabilities. Study procedures include laboratory testings, analytical readings as well as clinical assessment practices for treatment efficacy and safety evaluations.
|Contact: Kou-Wha Kuo, Ph.D||886065052976 ext email@example.com|
|Contact: Tony Chiu, B.S||886065052976 ext firstname.lastname@example.org|
|Kaohsiung Medical University Chung-Ho Memorial Hospital||Recruiting|
|Contact: Chung-Hsing Cha, MD 011-886-7-312-1101 ext 6107 email@example.com|
|Principal Investigator: Chung-Hsing Cha, MD|
|Kaohsiung Veterans General Hospital||Recruiting|
|Contact: Chien-Hui Hong, MD 011-886-7-342-2121 ext 4304 firstname.lastname@example.org|
|Principal Investigator: Chien-Hui Hong, MD|
|Kaohsiung Chang Gung Memorial Hospital||Recruiting|
|Contact: Wei-Ming Wu, MD 011-886-7-7317123 ext 2424 email@example.com|
|Principal Investigator: Wei-Ming Wu, MD|
|National Cheng Kung University Hospital||Recruiting|
|Contact: Tak-Wah Wong, MD 011-886-6-2353535 ext 5352 firstname.lastname@example.org|
|Principal Investigator: Tak-Wah Wong, MD|
|Chi Mei Medical Center YongKang||Recruiting|
|Contact: Ming-Hsien Lin, MD 011-886-6-281-2811 ext 57109 email@example.com|
|Principal Investigator: Feng-Jie Lai, MD|
|Principal Investigator:||Hamm-Ming Sheu, MD||National Cheng-Kung University Hospital|