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
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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
24 weeks
Yes
Hamm-Ming Sheu, MD
Principal Investigator
National Cheng-Kung University Hospital
Taiwan : Food and Drug Administration
GESRTAKA
NCT01493921
October 2011
April 2014
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