Effect of FPP on Cutaneous Barrier Integrity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-75
SponsorUniversity of Pittsburgh
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Fermented Papaya Preparation (FPP)
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Pittsburgh
Lead sponsor
Osato Research Institute
Collaborator
Source ClinicalTrials.gov