NCT01516515已完成2 期
A Double-blind, Randomized, Vehicle-controlled, Parallel-group, Phase II Study to Evaluate the Efficacy and Safety of SR-T100 Gel in Patients With Actinic Keratosis (AK)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 8
- 主要终点
- Total clearance rate:
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
placebo, gel
Placebo Comparator
placebo comparator
干预措施: Vehicle gel (Drug)
SR-T100 with 2.3% of SM, gel
Active Comparator
2.3% of SM in Solanum undatum plant extract
干预措施: SR-T100 with 2.3% of SM (Drug)
结局指标
主要结局
Total clearance rate:
时间窗: 8-week post-EOT visit (scheduled at Week 24 visit)
The proportion of patients achieving total clearance of AK lesions in the treatment area (in total of 25cm2 area) at 8-week post-EOT visit (scheduled at Week 24 visit) .
次要结局
- Partial clearance rate(24 week)
研究者
研究点 (8)
Loading locations...
相似试验
暂停
2 期
Efficacy and Safety of SR-T100 Gel in Common Warts (CW) PatientsCommon WartNCT01796795G&E Herbal Biotechnology Co., LTD102
已完成
早期 1 期
SR-T100 Gel Efficacy & Safety Study for Vulva Pre-cancerous Lesions & Cutaneous CondylomaGenital WartsVulvar Intraepithelial NeoplasiaNCT01676792National Cheng-Kung University Hospital29
招募中
2 期
A Trial to Evaluate the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Seborrheic KeratosisSeborrheic KeratosisNCT06108024DermBiont, Inc.60
已完成
2 期
Clinical Study Assessment of SR-T100 Topical Gel Against Actinic KeratosisBowen's DiseaseActinic KeratosisNCT02085395G&E Herbal Biotechnology Co., LTD27
已完成
2 期
Efficacy and Safety Profiles of SR-T100 Gel on External Genital Warts/Condyloma Acuminate(EGWs)Genital WartsCondyloma AcuminataCondylomata AcuminataVenereal WartsNCT01796821G&E Herbal Biotechnology Co., LTD138