Effect of FPP on Cutaneous Barrier Integrity | NCT07725835

NCT07725835

Overview

NCT ID: NCT07725835
Lead Sponsor: University of PittsburghOTHER
Official Title: Pilot Study of Fermented Papaya Preparation (FPP) Impact on Transepidermal Water Loss of Skin on Face, Arms, and Hands
Brief Summary: 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.
Conditions: Skin Hydration in Healthy Volunteers

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
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.

Central Contacts: Savita Khanna, PhDContact
savitakhanna@pitt.edu412-624-5500