Effect of FPP on Cutaneous Barrier Integrity (FPP OSATO)

Pilot Study of Fermented Papaya Preparation (FPP) Impact on Transepidermal Water Loss of Skin on Face, Arms, and Hands

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Skin Hydration in Healthy Volunteers
• Intervention / Treatment: Dietary supplement: Fermented Papaya Preparation (FPP)

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Savita Khanna, PhD; Phone Number: 412-624-5500; Email: savitakhanna@pitt.edu
• Study Contact Backup: Name: Scot King, DPT; Email: scot.king@pitt.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15219
      • McGowan Institute for Regenerative Medicine
      • Contact: Savita Khanna, PhD; Phone Number: 412-624-5500; Email: savitakhanna@pitt.edu
      • Contact: Scot King, DPT; Email: scot.king@pitt.edu
      • Principal Investigator: Savita Khanna, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 50-75 years
2. Willing to allow collection of 3 blood samples (Baseline, Week 12 and Week 20)
3. Willing to log daily compliance with FPP intake during the study period (12 weeks)
4. Absence of active systemic disease per investigator judgement.
5. No current use of immunosuppressant or immunomodulatory medications.
6. No active dermatological conditions at measurement sites that could impair measure, per investigator judgement.
7. Investigator determination of general good health.

Exclusion Criteria:

1. Co-morbidity or concurrent medication that the Investigator deems impactful to patient safety or ability to adhere to FPP dosage.
2. Co-morbidity or concurrent medication that the Investigator deems confounding to outcome measure (i.e., topical or systemic steroid).
3. Current or history of allergy to FPP ingredients: Dextrose, Carica papaya, or Food yeast.
4. Concurrent participation in another interventional trial that may impact measures, per investigator judgement.
5. Uncontrolled diabetes (A1c >7%).
6. Open wounds or actively receiving Wound Care services.
7. Pregnant or breastfeeding women.
8. Current use of warfarin.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fermented Papaya Preparation; Fermented Papaya Preparation Supplement	Dietary supplement: Fermented Papaya Preparation (FPP); Immun'Age Fermented Papaya Preparation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transepidermal Water Loss (TEWL)	9 anatomical sites. Unit g/m²/h	From enrollment to the end of FPP at 12 weeks.
Skin surface pH	9 anatomical sites.	From enrollment to the end of FPP at 12 weeks.
Skin surface temperature	9 anatomical sites. Unit Celsius	From enrollment to the end of FPP at 12 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monocyte Inflammation Marker	CD16	From enrollment to the end of FPP at 12 weeks.
Glucose Levels	Unit mg/dL	From enrollment to the end of FPP at 12 weeks.
HbA1c Levels	Percentage	From enrollment to the end of FPP at 12 weeks.
Complete Blood Count (CBC)	Absolute Counts	From enrollment to the end of FPP at 12 weeks.

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Osato Research Institute
• Investigators: Principal Investigator: Savita Khanna, PhD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: July 21, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: fermented papaya preparation
• Other Study ID Numbers: STUDY26010104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No