NCT01885091已完成4 期
Kinerase® Interactive Skin-care Study: A Multicentre, Phase IV, Single-arm, Open-label Trial to Evaluate the Efficacy and Safety of Kinetin, N6-furfuryladenine, 0.1% for Treatment of Cutaneous Facial Photodamage
Menarini (Thailand) Limited2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年12月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- To assess the physician's evaluation and patient's self-evaluation at 8 weeks.
研究概览
简要总结
The purpose of the K.I.S.S. study is to evaluate the efficacy of Kinerase® Cream (Kinetin 0.1%) in Thai patients, on the basis of the severity and clinical signs of facial photodamage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects older than 35 years of age and less than 65 years of age.
- •Subjects with mild, moderate or severe facial photodamage as assessed by a 10-point scale.
- •Subjects willing to sign an informed consent and adhere to all protocol requirements.
排除标准
- •Male and female subjects with suspected porphyria, systemic or cutaneous erythematosus lupus, or any other photosensitizing disorder or drug-induced photosensitization.
- •Subjects with chronic or recurring skin disease or disorder.
- •Subjects with any active infectious skin disorder (Herpes simplex, molluscum contagiosum, and facial warts).
- •Subjects with skin cancer of the facial tissues.
- •Subjects who have received any laser/ intense pulsed light (IPL) / chemical peel in the 2 months preceding the screening visit.
- •Subjects with a history of topical and/or oral isotretinoin use, 6 months prior to the screening visit.
- •Subjects who have been on topical Retin-A or Renova in the 2 months prior to the screening visit.
- •Subjects who have used topical alpha-hydroxy acid skin care products in the month preceding the screening visit.
- •Subjects currently on any anti-aging products and who wish to continue use of their products.
- •Subjects requiring concurrent treatment that would interfere with the study assessments.
- •Pregnant or lactating female subjects.
结局指标
主要结局
To assess the physician's evaluation and patient's self-evaluation at 8 weeks.
时间窗: 8 weeks
To assess the physician's evaluation and patient's self-evaluation at 12 weeks.
时间窗: 12 weeks
To assess the physician's evaluation and patient's self-evaluation at 4 weeks.
时间窗: 4 weeks
次要结局
未报告次要终点
研究者
研究点 (2)
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