Pilot Study of Fermented Papaya Preparation (FPP) Impact on Transepidermal Water Loss of Skin on Face, Arms, and Hands
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Transepidermal Water Loss (TEWL)
研究概览
简要总结
This pilot study will test how Fermented Papaya Preparation (FPP) impacts overall TEWL of areas that commonly display diminished barrier function, such as the skin from face, arms, and hands. Areas of diminished barrier function are defined as those not visible to the eye but identified as areas of high transepidermal water loss (TEWL) as measured by a non-invasive pen-like device. A TEWL value of 20 or higher at a location would be considered high TEWL. Participants will attend 5 visits over 20 weeks, with 12-weeks of FPP treatment, and 8-weeks of follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •50-75 years
- •Willing to allow collection of 3 blood samples (Baseline, Week 12 and Week 20)
- •Willing to log daily compliance with FPP intake during the study period (12 weeks)
- •Absence of active systemic disease per investigator judgement.
- •No current use of immunosuppressant or immunomodulatory medications.
- •No active dermatological conditions at measurement sites that could impair measure, per investigator judgement.
- •Investigator determination of general good health.
排除标准
- •Co-morbidity or concurrent medication that the Investigator deems impactful to patient safety or ability to adhere to FPP dosage.
- •Co-morbidity or concurrent medication that the Investigator deems confounding to outcome measure (i.e., topical or systemic steroid).
- •Current or history of allergy to FPP ingredients: Dextrose, Carica papaya, or Food yeast.
- •Concurrent participation in another interventional trial that may impact measures, per investigator judgement.
- •Uncontrolled diabetes (A1c >7%).
- •Open wounds or actively receiving Wound Care services.
- •Pregnant or breastfeeding women.
- •Current use of warfarin.
研究组 & 干预措施
Fermented Papaya Preparation
Fermented Papaya Preparation Supplement
干预措施: Fermented Papaya Preparation (FPP) (Dietary Supplement)
结局指标
主要结局
Transepidermal Water Loss (TEWL)
时间窗: From enrollment to the end of FPP at 12 weeks.
9 anatomical sites. Unit g/m²/h
Skin surface pH
时间窗: From enrollment to the end of FPP at 12 weeks.
9 anatomical sites.
Skin surface temperature
时间窗: From enrollment to the end of FPP at 12 weeks.
9 anatomical sites. Unit Celsius
次要结局
- Monocyte Inflammation Marker(From enrollment to the end of FPP at 12 weeks.)
- Glucose Levels(From enrollment to the end of FPP at 12 weeks.)
- HbA1c Levels(From enrollment to the end of FPP at 12 weeks.)
- Complete Blood Count (CBC)(From enrollment to the end of FPP at 12 weeks.)
研究者
Savita Khanna
Professor
University of Pittsburgh