NCT02085395

Clinical Study Assessment of SR-T100 Topical Gel Against Actinic Keratosis

An Open Phase II Study to Assess the Efficacy and Safety of Topical SR-T100® Gel in the Treatment of Human Cutaneous Squamous Cell Carcinoma in Situ (Actinic Keratosis and Bowen's Disease)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: G&E Herbal Biotechnology Co., LTD · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy of SR-T100 gel by observing the lesion size (length x width x height) of human cutaneous squamous cell carcinoma in situ (Actinic Keratosis and Bowen's Disease) reduced at least 75%.

Detailed description

An open phase II study to assess the efficacy and safety of topical SR-T100 gel in the treatment of human cutaneous cell carcinoma in situ (Actinic Keratosis and Bowen's Disease). The primary efficacy endpoint defines as the proportion of patients whose lesion size reduced at least 75%. The secondary efficacy endpoints include complete clearance rate as the proportion of patients with no clinical visible AK/BD lesions in the treatment area, partial clearance rate as the proportion of patients at least a 75% reduction of AK/BD lesion size in teh treatment area, and histological response rate as the proportion of patients with biopsy proven clearance of AK and BD in situ. Safety was evaluated by clinically significant changes occurring from baseline to the end of the study by observing physical examination, vital signs, laboratory assessments and AEs.

Conditions

• Actinic Keratosis
• Bowen's Disease

Interventions

Type	Name	Description
DRUG	SR-T100 ® Gel

Timeline

• Start date: 2007-11-01
• Primary completion: 2010-04-01
• Completion: 2010-11-01
• First posted: 2014-03-12
• Last updated: 2014-03-14

Locations

1 site across 1 country: Taiwan