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Clinical Trials List

Protocol NumberGESRTAKA
NCT Number(ClinicalTrials.gov Identfier)NCT01493921

2011-07-01 - 2015-07-31

Phase III

Terminated6

ICD-10L57.0

Actinic keratosis

ICD-9702.0

Actinic keratosis

A Randomized, Double-Blind, Parallel, Vehicle-Controlled Phase III Trail to Assess the Efficacy and Safety of Topical SR-T100 Gel in the Treatment of Patients with Actinic Keratosis

  • Trial Applicant

    STATPLUS, INC.

  • Sponsor

    G&E Herbal Biotechnology Co.

  • Trial scale

    Taiwan Multiple Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator 洪千惠 Division of Dermatology
Kaohsiung Veterans General Hosptial

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Chung-Hsing Chang Division of Dermatology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 賴豐傑 Division of Dermatology
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 吳唯銘 Division of Dermatology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 紀景琪 Division of Dermatology
Chiayi Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Tak-Wah Wong Division of Dermatology
National Taiwan University Hospital

Taiwan National PI

王德華

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

14 Terminated

Condition/Disease

Actinic Keratosis

Objectives

The primary objective of this study is to demonstrate a clinically significant outcome involving SR-T100 topical gel developed against skin lesions such as AK. Furthermore, evaluation of SR-T100 efficacy & tolerability in treating AK lesions are developed as secondary objective in this clinical study.

Test Drug

SR-T100

Active Ingredient

Solamargine extract gel

Dosage Form

gel

Dosage

2.3%

Endpoints

1.The primary objective is to compare the complete clearance rate between treatment groups at 8 weeks after the completion of 16 weeks study treatment. The primary efficacy endpoint is to evaluate the complete clearance rate at 8 weeks after the completion of 16 weeks study treatment between treatment groups. The complete clearance is defined as the absence of visible or palpable AK lesions in the treatment area.
2.SR-T100 clinical application in Actinic Keratosis treatment as direct proportional relationship to lesion size reduction, complete & partial clearance defined consequently as 100% & ≧75% reduction, coordinated toxicity & bio-safety reports supplements additional case study basis & foundation.

Inclution Criteria

Male or female is 20 years of age or above and patient has at least two clinically visible, discrete, non hyperkeratotic, hypertrophic AK lesions located within a 25 cm squared contiguous or non contiguous treatment area including the arms, shoulder, chest, face and scalp. Patient has at least one histological confirmed actinic keratosis lesion of greater or equal to 4 mm in diameter within the selected treatment area.

Exclusion Criteria

Patient has any dermatological disease and condition, such as atopic dermatitis, basal cell carcinoma, eczema, psoriasis, rosacea, squamous cell carcinoma, melanoma, or other possible confounding skin conditions in the treatment or surrounding area within 5cm distances from treatment area.
Patient had used the following treatments within 4 weeks prior to the study treatment initiation as immunomodulators or immunosuppressive therapy,interferon and cytotoxic drugs.
Patient treated with topical 5 FU, diclofenac gel, imiquimod, corticosteroids, retinoids, masoprocol on the treatment area within 4 weeks prior to the study treatment initiation.
Patient received cryodestruction, chemodestruction, curettage, photodynamic therapy, surgical excision on the treatment area within 4 weeks prior to the study treatment initiation.
Patient had received any of the following treatments on the treatment area in 6 months before study treatment initiation begins, such as psoralen plus UVA therapy, UVB therapy, laser abrasion, dermabrasion chemical peel.
Patient is known to be hypersensitive to the study medication.
Female who is pregnant, breast fed or considers of becoming pregnant while on the study.
Patient had used of any investigational drug within the past 30 days before enrollment.

The Estimated Number of Participants

  • Taiwan

    113 participants

  • Global

    0 participants

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