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

NCT02085395 | Completed Phase 2 DMC

• 1 other identifier: MCCD06003A
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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%.

Conditions

Actinic Keratosis; Bowen's Disease

Keywords

Actinic Keratosis, AK, Bowen's Disease, Bowen

Outcome Measures

Primary Outcomes (1)

• 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%.

  16 weeks treatment and 4 weeks follow-up

Secondary Outcomes (2)

• Complete clearance rate

  16 weeks treatment and 4 weeks follow-up

• Partial clearance rate

  16 weeks treatment and 4 weeks follow-up

Other Outcomes (1)

• Histological response rate

  2-16 weeks

Study Arms (1)

SR-T100 ® Gel

EXPERIMENTAL

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

Interventions

SR-T100 ® Gel DRUG

Also known as: SR-T100

SR-T100 ® Gel

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• G&E Herbal Biotechnology Co., LTD: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, Taiwan

Location

MeSH Terms

Conditions

Keratosis, Actinic; Bowen's Disease

Interventions

SR-T100

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Study Officials

• Dr. Hamm-Ming Sheu, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2014
• First Posted: March 12, 2014
• Study Start: November 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: November 1, 2010
• Last Updated: March 14, 2014

Record last verified: 2014-03

Locations

TW (1)