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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 B

Brief 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 Summary: 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.
Sponsor: G&E Herbal Biotechnology Co., LTD

Current Primary Outcome: Partial clearance rate [ Time Frame: 16 weeks treatment and 4 weeks follow-up ]

To assess the response rate of SR-T100® gel in patients with cutaneous squamous cell carcinoma in situ (Actinic Keratosis: AK; and Bowen's Disease: BD), defined as the proportion of patients whose lesion size (length x width x height) reduced > 75%.


Original Primary Outcome: Partial clearance rate [ Time Frame: 20 weeks ]

To assess the response rate of SR-T100® gel in patients with cutaneous squamous cell carcinoma in situ (Actinic Keratosis: AK; and Bowen's Disease: BD), defined as the proportion of patients whose lesion size (length x width x height) reduced > 75%.


Current Secondary Outcome:

  • Complete clearance rate [ Time Frame: 16 weeks treatment and 4 weeks follow-up ]
  • Partial clearance rate [ Time Frame: 16 weeks treatment and 4 weeks follow-up ]


Original Secondary Outcome:

  • Complete clearance rate [ Time Frame: 20 weeks ]
  • Partial clearance rate [ Time Frame: 20 weeks ]


Information By: G&E Herbal Biotechnology Co., LTD

Dates:
Date Received: March 11, 2014
Date Started: November 2007
Date Completion:
Last Updated: March 13, 2014
Last Verified: March 2014