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

NCT01493921 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2016-02-19

No results posted yet for this study

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.

Conditions

  • Actinic Keratosis

Interventions

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.

Sponsors & Collaborators

  • G&E Herbal Biotechnology Co., LTD

    lead INDUSTRY

Principal Investigators

  • Hamm-Ming Sheu, MD · National Cheng-Kung University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01493921 on ClinicalTrials.gov