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

NCT ID: NCT02085395

Last Updated: 2014-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2010-11-30

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.

Conditions

Actinic Keratosis; Bowen's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SR-T100 ® Gel

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

Group Type: EXPERIMENTAL

SR-T100 ® Gel

Intervention Type: DRUG

Interventions

SR-T100 ® Gel

Intervention Type: DRUG

Other Intervention Names

SR-T100

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

G&E Herbal Biotechnology Co., LTD

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr. Hamm-Ming Sheu, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology National Cheng Kung University Hospital Tainan, Taiwan, ROC

Locations

National Cheng Kung University Hospital

Tainan City, , Taiwan

Countries

Taiwan

Other Identifiers

MCCD06003A

Identifier Type: -

Identifier Source: org_study_id