Status:
COMPLETED
Efficacy Study & Safety Evaluation of SR-T100 Gel in Actinic Keratosis Treatment
Lead Sponsor:
G&E Herbal Biotechnology Co., LTD
Conditions:
Actinic Keratosis
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
Studies of SR-T100 gel and its clinical relevance in the treatment of AK, providing adequate measured outcomes for skin lesion treatment. In addition to the high complete response rate (90.0%) as comp...
Detailed Description
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 effic...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT01493921
Start Date
October 1 2011
End Date
November 1 2015
Last Update
February 19 2016
Active Locations (6)
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1
Chiayi Chang Gung Memorial Hospital
Chiayi City, Taiwan
2
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
3
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
4
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan