drugset / Trial / NCT01493921

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

NCT01493921 ↗

Phase 3 Completed 113 enrolled G&E Herbal Biotechnology Co., LTD
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2011-10
Primary completion
2015-11
Completion
2015-11

Drugs

EvaluationDrugModalityDoseRoute
Subject SR-T100 Unknown 0.3 g Topical
Subject SR-T100 Unknown 0.5 g Topical

Indications