A Single Arm, Phase IV, Open-Label, Split-Face Trial to Evaluate the Efficacy and Safety of Kinetin, N6-furfuryladenine, 0.1% for Treatment of Cutaneous Photoaging
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 4
- 主要终点
- Skin Roughness
研究概览
简要总结
The purpose of the study is to evaluate the change in the severity and clinical signs of skin photoaging among Filipino patients using Kinerase cream (Kinetin 0.1%). This study will recruit 132 subjects from dermatological clinics in a tertiary hospital in the Philippines for a period of 3 months (12 weeks). Changes in severity will be documented using physician evaluation, self-evaluation, and through VISIA complexion analysis system.
详细描述
This study is a single-arm, open-label, split-face trial in subjects with mild to moderate photoaged facial skin. The study will enroll around 132 subjects from selected private dermatology clinics in a tertiary hospital in the Philippines.
Patients from selected private dermatology clinics of a tertiary hospital will be screened and recruited to participate. They will be provided a written consent form (Appendix I) before they will be included in the study.
Following enrollment, subjects will return for outpatient visits at weeks 4, 8, and 12 for assessment.
The whole study will be conducted from July 2013 to November 2013. The first month would involve recruitment of patients. Qualified patients will start the 12-week treatment period and will be asked to follow up every 4 weeks. The last two months would be for data analysis, interpretation and writing of the scientific report.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Filipino and Asian female subjects from private clinics of a tertiary hospital in the Philippines older than 35 years of age and less than 65 years of age.
- •Subjects with mild to moderate cutaneous photoaging as assessed by the investigator's assessment 6-point scale.
- •Subjects willing to sign an informed consent and adhere to all protocol requirements.
排除标准
- •Suspected porphyria, systemic or cutaneous lupus erythematosus, or any other photosensitizing disorder or drug-induced photosensitization
- •Chronic or recurring skin disease or disorder
- •Any active infectious skin disorder (Herpes simplex, molluscum contagiosum, and facial warts)
- •Skin cancer of the facial tissues
- •Any laser/IPL/ chemical peel in the 2 months preceding the screening visit
- •History of Isotretinoin use, 6 months prior to the screening disease
- •Topical tretinoin or adapalene in the 2 months prior to the screening visit
- •Used topical alpha-hydroxy acid skincare products in the month preceding the screening visit
- •On any anti-aging products and who wish to continue use of their products
- •Requiring concurrent treatment that would interfere with the study assessments
- •Pregnant or lactating females
结局指标
主要结局
Skin Roughness
时间窗: 12 weeks
Measured using Physician Evaluation and Patient Self-Evaluation of severity of cutaneous photoaging at baseline week, weeks 4, 8, and 12
Pigmentation
时间窗: 12 weeks
Also called Mottling or Blotchiness. This is measured using Physician Evaluation and Patient Self-Evaluation of severity of cutaneous photoaging at baseline week, weeks 4, 8, and 12
Pores
时间窗: 12 weeks
Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.
Fine wrinkles
时间窗: 12 weeks
Measured using Physician Evaluation and Patient Self-Evaluation of severity of cutaneous photoaging at baseline week, weeks 4, 8, and 12
Global Improvement in Cutaneous Photoaging
时间窗: 12 weeks
Measured using Physician Evaluation and Patient Self-Evaluation of severity of cutaneous photoaging at baseline week, weeks 4, 8, and 12
Wrinkles
时间窗: 12 weeks
Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.
Texture
时间窗: 12 weeks
Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.
Porphyrins
时间窗: 12 weeks
Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.
Visual Spots
时间窗: 12 weeks
Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.
UV spots
时间窗: 12 weeks
Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.
Brown Spots
时间窗: 12 weeks
Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.
Red Areas
时间窗: 12 weeks
Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.
次要结局
- Erythema(12 weeks)
- Burning(12 weeks)
- Peeling(12 weeks)
- Pruritus(12 weeks)
- Dryness(12 weeks)
- Edema(12 weeks)
- Acne(12 weeks)
研究者
Ma. Purita Paz-Lao, MD, FPDS
Chairman
Makati Medical Center