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 trial explores how a supplement made from fermented papaya, known as Fermented Papaya Preparation (FPP), can help maintain skin hydration by reducing water loss through the skin. It focuses on areas like the face, arms, and hands, where the skin's barrier may not function optimally, leading to increased water escape. Individuals with dry skin or skin hydration issues, who are generally in good health without active skin conditions, may find this trial suitable. Participants will take the supplement for 12 weeks and attend five visits over 20 weeks. As an unphased trial, this study provides an opportunity to contribute to understanding how FPP can benefit skin hydration.

Will I have to stop taking my current medications?

The trial does not specify if you must stop all current medications, but you cannot use immunosuppressant, immunomodulatory, or certain other medications that the investigator thinks might affect the study. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that Fermented Papaya Preparation is safe for use on the skin?

In a previous study, Fermented Papaya Preparation (FPP) proved easy for people to tolerate. Research has shown that FPP supports the immune system and reduces inflammation without causing major side effects. Another study found that FPP acts as a strong antioxidant, protecting cells from damage. These studies reported no serious negative effects.

Safety data also indicates that papaya extract, a main ingredient in FPP, is not harmful. Animal tests required very high doses to cause any harm, suggesting that FPP is generally safe for humans based on past research.

These findings suggest that FPP might be safe for participants. However, consulting a healthcare provider before joining a clinical trial is always advisable.12345

Why are researchers excited about this trial?

Fermented Papaya Preparation (FPP) is unique because it offers a natural alternative for improving skin hydration, unlike standard moisturizers or hydrating serums that often rely on synthetic chemicals. FPP is derived from fermented papaya, which may provide antioxidant benefits while enhancing the skin's moisture retention. Researchers are excited about FPP because it could support skin health more holistically, potentially reducing reliance on conventional products with harsh ingredients.

What evidence suggests that Fermented Papaya Preparation might be an effective treatment for skin hydration?

Studies have shown that Fermented Papaya Preparation (FPP) benefits the skin due to its antioxidant and anti-inflammatory properties. It helps protect the skin by reducing damage and irritation, which can harm skin cells. Reports also suggest that FPP aids in managing skin conditions like psoriasis, potentially improving overall skin health. Additionally, research has found FPP to be a helpful supplement in various treatments, indicating broad health benefits. In this trial, participants will receive FPP to evaluate its effectiveness in improving skin moisture and strength.678910

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+

Citations

fermented papaya preparation: Topics by ...

Our data suggest that the incubation with FPP may have a protective effect on platelets from patients with DM 2, by preventing the progression of oxidative ...

Researchers to examine effects of fermented papaya ...

A 2022 review of published studies on the effects of FPP in humans found that the supplement is an excellent addition to combined therapies for ...

Applications and bioefficacy of the functional food ...

FPP favorably modulates immunological, hematological, inflammatory, vascular and oxidative stress damage parameters. exhibiting anti-inflammatory, antioxidant, ...

Anti-Tumor and Immunoregulatory Effects of Fermented ...

Various beneficial effects have been described for fermented papaya preparation (FPP: SAIDO-PS501) based on its anti-oxidative and anti-inflammatory functions.

Benefits of Fermented Papaya in Human Health

They induced burn trauma in Wistar rats (burns IIA-B-20% of skin area) and evaluated the effects of the preparation from fermented papaya.

year double-blind rct testing fermented papaya preparation

The aim of this study was to complete a 24-month investigation of the potential beneficial effect of this functional food on key age- related ...

Applications and bioefficacy of the functional food ...

FPP favorably modulates immunological, hematological, inflammatory, vascular and oxidative stress damage parameters.

The Effect of Fermented Papaya Preparation on ...

Fermented papaya preparation … has been shown to act as an antioxidant. PP to prevent radiation-induced damage.

Applications and bioefficacy of the functional food ...

FPP favorably modulates immunological, hematological, inflammatory, vascular and oxidative stress damage parameters.

Fermented papaya preparation attenuates beta-amyloid ...

papaya seeds water extract is not toxic and acts as a potent free radical scavenger, providing protection to Detroit 550 fibroblasts that underwent H2O2 ...