Fermented Papaya for Skin Hydration

(FPP OSATO Trial)

SK
SK
Overseen ByScot King, DPT
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

SK

Savita Khanna, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for adults aged 50 to 75 who are generally healthy, have no active skin diseases at test sites, and aren't taking immune-suppressing drugs. Participants must not be pregnant or breastfeeding, have open wounds, uncontrolled diabetes, allergies to FPP ingredients, or use warfarin.

Inclusion Criteria

Willing to log daily compliance with FPP intake during the 12-week study period
Willing to allow collection of 3 blood samples (Baseline, Week 12, and Week 20)
Absence of active systemic disease per investigator judgement
See 4 more

Exclusion Criteria

I have open wounds or am currently receiving wound care.
I am currently pregnant or breastfeeding.
Concurrent participation in another interventional trial that may impact measures, per investigator judgement
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Fermented Papaya Preparation (FPP) for 12 weeks to assess its impact on transepidermal water loss (TEWL) and other skin parameters

12 weeks
5 visits over 20 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Fermented Papaya Preparation (FPP)

Trial Overview

The study tests whether Fermented Papaya Preparation (FPP) can improve the skin's barrier by reducing water loss in areas with weak skin protection. Participants take FPP for 12 weeks and attend five visits over a total of 20 weeks.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Fermented Papaya PreparationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials
1,820
Recruited
16,360,000+

Osato Research Institute

Collaborator

Trials
7
Recruited
470+