NCT07725835

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
23mo left

Started Jul 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Jul 2026Jul 2028

Study Start

First participant enrolled

July 1, 2026

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

July 24, 2026

Status Verified

July 1, 2026

Enrollment Period

1.8 years

First QC Date

July 21, 2026

Last Update Submit

July 21, 2026

Conditions

Skin Hydration in Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • 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.

Study Arms (1)

Fermented Papaya Preparation

EXPERIMENTAL

Fermented Papaya Preparation Supplement

Dietary Supplement: Fermented Papaya Preparation (FPP)

Interventions

Fermented Papaya Preparation (FPP)DIETARY_SUPPLEMENT

Immun'Age Fermented Papaya Preparation

Fermented Papaya Preparation

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGowan Institute for Regenerative Medicine

Pittsburgh, Pennsylvania, 15219, United States

Location

MeSH Terms

Interventions

fermented papaya preparation

Study Officials

  • Savita Khanna, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Savita Khanna, PhD

CONTACT

412-624-5500savitakhanna@pitt.edu

Scot King, DPT

CONTACT

scot.king@pitt.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 21, 2026

First Posted

July 24, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

July 24, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)