NCT01493921

Efficacy Study & Safety Evaluation of SR-T100 Gel in Actinic Keratosis Treatment

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: G&E Herbal Biotechnology Co., LTD · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2011-10-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2011-12-16
• Last updated: 2016-02-19

Locations

6 sites across 1 country: Taiwan