Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2026-03-20 @ 2:32 AM
Study NCT ID:
NCT02085395
Status:
COMPLETED
Last Update Posted:
2014-03-14
First Post:
2014-03-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study Assessment of SR-T100 Topical Gel Against Actinic Keratosis
Sponsor:
G&E Herbal Biotechnology Co., LTD
Organization:
Study Overview
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 Bowen's Disease)
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AK
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 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: