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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
G&E Herbal Biotechnology Co., LTD

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 14, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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