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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
113
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.
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.
Chiayi Chang Gung Memorial Hospital
Chiayi City, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
Chi Mei Medical Center YongKang
Tainan, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
Comparison of SR-T100 gel effect with those of vehicle gel (Placebo) on efficacy and tolerability in patients with actinic keratosis
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
Time frame: 24 weeks
Evaluation of efficacy and tolerability of SR-T100 gel in AK treatment
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.
Time frame: 24 weeks
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