Effect of FPP on Cutaneous Barrier Integrity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fermented Papaya Preparation (FPP).
- Who it may be relevant to
- Registry conditions: Skin Hydration in Healthy Volunteers. Basic parameters: 50 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pilot Study of Fermented Papaya Preparation (FPP) Impact on Transepidermal Water Loss of Skin on Face, Arms, and Hands
Overview
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.
Interventions
- Dietary supplement Fermented Papaya Preparation (FPP)
Immun'Age Fermented Papaya Preparation
Primary outcome measures
- Transepidermal Water Loss (TEWL) [Time frame: From enrollment to the end of FPP at 12 weeks.]
- Skin surface pH [Time frame: From enrollment to the end of FPP at 12 weeks.]
- Skin surface temperature [Time frame: From enrollment to the end of FPP at 12 weeks.]
Secondary outcome measures (4)
- Monocyte Inflammation Marker [Time frame: From enrollment to the end of FPP at 12 weeks.]
- Glucose Levels [Time frame: From enrollment to the end of FPP at 12 weeks.]
- HbA1c Levels [Time frame: From enrollment to the end of FPP at 12 weeks.]
- Complete Blood Count (CBC) [Time frame: From enrollment to the end of FPP at 12 weeks.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- McGowan Institute for Regenerative Medicine — Pittsburgh
Identifiers
NCT: NCT07725835 · STUDY26010104