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

March 13, 2014 updated by: G&E Herbal Biotechnology Co., LTD

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)

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%.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Tainan, Taiwan
        • National Cheng Kung University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SR-T100 ® Gel
Topical gel containing 2.3% of solamargine in Solanum undatum extract is used once daily with occlusive dressing for 16 weeks.
Drug: SR-T100 ® Gel
Other Names:
  • SR-T100

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%.
16 weeks treatment and 4 weeks follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Complete clearance rate
Time Frame: 16 weeks treatment and 4 weeks follow-up
16 weeks treatment and 4 weeks follow-up
Partial clearance rate
Time Frame: 16 weeks treatment and 4 weeks follow-up
16 weeks treatment and 4 weeks follow-up

Other Outcome Measures

Outcome Measure
Time Frame
Histological response rate
Time Frame: 2-16 weeks
2-16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

G&E Herbal Biotechnology Co., LTD

Investigators

  • Principal Investigator: Dr. Hamm-Ming Sheu, MD, Department of Dermatology National Cheng Kung University Hospital Tainan, Taiwan, ROC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

March 11, 2014

First Submitted That Met QC Criteria

March 11, 2014

First Posted (Estimate)

March 12, 2014

Study Record Updates

Last Update Posted (Estimate)

March 14, 2014

Last Update Submitted That Met QC Criteria

March 13, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCCD06003A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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