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

Primary Purpose

Actinic Keratosis, Bowen's Disease

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
SR-T100 ® Gel
Sponsored by
G&E Herbal Biotechnology Co., LTD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratosis focused on measuring Actinic Keratosis, AK, Bowen's Disease, Bowen

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients met ALL of the inclusion criteria for the entry of this study:

    1. Male or female; aged ≧ 20 years old.
    2. Patients had histologically confirmed Squamous cell carcinoma in situ (AK or BD) for the targeted lesion.
    3. Patients had a measurable lesion 5mm or larger for AK or 10mm or larger for BD.
    4. Patient had a performance status of < 2 (ECOG).
    5. Patients who had signed an approved written informed consent.

Exclusion Criteria:

  • Patients were excluded from this study for ANY of the following reasons:

    1. Patients with histologic subtypes other than squamous cell carcinoma in situ (AK or BD).
    2. Patients with tumor extending into the oral cavity, nostrils, eyelids, urethra, anus, vagina or rectum.
    3. Patients who had grossly suspicious or inflamed nodes on physical examination.
    4. Patients with grossly infected tumors.
    5. Patients with recurrent invasive squamous cell carcinoma.
    6. Patients with a history of other invasive malignancies, if there was any evidence of the other malignancy being present within the past 5 years. Patients were also excluded if their previous cancer treatment contraindicated this protocol therapy.
    7. Use of any investigational drug in the 30 days before screening.
    8. Pregnant or lactating women or women of childbearing potential using inadequate contraceptive methods.

Sites / Locations

  • National Cheng Kung University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SR-T100 ® Gel

Arm Description

Topical gel containing 2.3% of solamargine in Solanum undatum extract is used once daily with occlusive dressing for 16 weeks.

Outcomes

Primary Outcome Measures

Partial clearance rate
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%.

Secondary Outcome Measures

Complete clearance rate
Partial clearance rate

Full Information

First Posted
March 11, 2014
Last Updated
March 13, 2014
Sponsor
G&E Herbal Biotechnology Co., LTD
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1. Study Identification

Unique Protocol Identification Number
NCT02085395
Brief Title
Clinical Study Assessment of SR-T100 Topical Gel Against Actinic Keratosis
Acronym
AK
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
G&E Herbal Biotechnology Co., LTD

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis, Bowen's Disease
Keywords
Actinic Keratosis, AK, Bowen's Disease, Bowen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SR-T100 ® Gel
Arm Type
Experimental
Arm Description
Topical gel containing 2.3% of solamargine in Solanum undatum extract is used once daily with occlusive dressing for 16 weeks.
Intervention Type
Drug
Intervention Name(s)
SR-T100 ® Gel
Other Intervention Name(s)
SR-T100
Primary Outcome Measure Information:
Title
Partial clearance rate
Description
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%.
Time Frame
16 weeks treatment and 4 weeks follow-up
Secondary Outcome Measure Information:
Title
Complete clearance rate
Time Frame
16 weeks treatment and 4 weeks follow-up
Title
Partial clearance rate
Time Frame
16 weeks treatment and 4 weeks follow-up
Other Pre-specified Outcome Measures:
Title
Histological response rate
Time Frame
2-16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients met ALL of the inclusion criteria for the entry of this study: Male or female; aged ≧ 20 years old. Patients had histologically confirmed Squamous cell carcinoma in situ (AK or BD) for the targeted lesion. Patients had a measurable lesion 5mm or larger for AK or 10mm or larger for BD. Patient had a performance status of < 2 (ECOG). Patients who had signed an approved written informed consent. Exclusion Criteria: Patients were excluded from this study for ANY of the following reasons: Patients with histologic subtypes other than squamous cell carcinoma in situ (AK or BD). Patients with tumor extending into the oral cavity, nostrils, eyelids, urethra, anus, vagina or rectum. Patients who had grossly suspicious or inflamed nodes on physical examination. Patients with grossly infected tumors. Patients with recurrent invasive squamous cell carcinoma. Patients with a history of other invasive malignancies, if there was any evidence of the other malignancy being present within the past 5 years. Patients were also excluded if their previous cancer treatment contraindicated this protocol therapy. Use of any investigational drug in the 30 days before screening. Pregnant or lactating women or women of childbearing potential using inadequate contraceptive methods.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Hamm-Ming Sheu, MD
Organizational Affiliation
Department of Dermatology National Cheng Kung University Hospital Tainan, Taiwan, ROC
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cheng Kung University Hospital
City
Tainan
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

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