Status:
COMPLETED
Efficacy and Safety Phase II Study of SR-T100 to Treat Actinic Keratosis
Lead Sponsor:
G&E Herbal Biotechnology Co., LTD
Conditions:
Actinic Keratosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This Phase II study is to evaluate the efficacy of SR-T100 gel with 2.3% of SM in Solanum undatum plant extract in patient with Actinic Keratosis (AK).
Eligibility Criteria
Inclusion
- Male or female; aged ≥ 18 years old.
- Patient who accepts to enter the study by signing written informed consent.
- Patient has 4 to 8 clinically diagnosed, discrete, non-hyperkeratotic, non-hypertrophic AK, located with or without a contiguous 25cm2 areas.
- Patient allows biopsy to be performed on selected lesion.
- Patient agrees to apply the study medication on prescribed treatment area with an occlusive dressing at least 20 hours per day.
- Patient agrees photographs to be taken on selected lesion and used as part of the study data package.
- Patient in good general health condition (performance status ≤ 2 Eastern Cooperative Oncology Group (ECOG).
- Sexually active female patient with child-bearing potential must take reliable contraception method(s) during the participation of the study.
Exclusion
- Patient with recurrent invasive squamous cell carcinoma (SCC).
- Patient has grossly suspicious or inflamed lymph nodes on physical examination.
- Patient has evidence of clinically significant or unstable medical conditions.
- Patient has any skin condition in the treatment area that may be made worse by treatment.
- Patient currently uses or had used on the treatment area(s) OTC retinol products, corticosteroids, cryosurgery, curettage, 5-fluorouracil (5-FU), imiquimod, topical diclofenac, retinoids, or other topical AK treatments (such as laser abrasion, dermabrasion, glycolic acids, or chemical peels) 28 days prior to screening visit.
- Patient had received systemic cancer chemotherapy or immunosuppressant; on the target evaluation area that psoralen plus UVA therapy, UVB therapy were treated 6 months prior to screening visit.
- Patient currently uses or has used prednisone and/or prednisolone (≥ 10 mg or the equivalent) more than 2 weeks continuously within 12 weeks prior to randomization visit.
- Engaging in activities involving excessive or prolonged exposure to sunlight.
- History of allergy or sensitivity to related compounds or other components of the investigational product formulation.
- Woman who is pregnant, lactating or planning to become pregnant during the study.
- Patient used any investigational drug within 8 weeks prior to the screening visit.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2018
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT01516515
Start Date
February 1 2013
End Date
October 1 2018
Last Update
December 5 2018
Active Locations (8)
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1
Contour Dermatology & Cosmetic Surgery Center
Rancho Mirage, California, United States, 92270
2
IMMUNOe International Research Centers
Longmont, Colorado, United States, 80501
3
Atlantic Clinical Research Collaborative
West Palm Beach, Florida, United States, 33406
4
Palm Beach Research Center
West Palm Beach, Florida, United States, 33409