Skin Barrier DysfunctionFPP OSATONCT07725835
Effect of FPP on Cutaneous Barrier Integrity
A study testing Fermented Papaya Preparation (FPP) in people with Skin Barrier Dysfunction and Healthy Volunteers, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Barrier Dysfunction, Healthy Volunteers
- What is being tested?
- Fermented Papaya Preparation (FPP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Jul 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Scot King, DPT contact
United States1 site
McGowan Institute for Regenerative Medicine
Pittsburgh, Pennsylvania, 15219
Savita Khanna, PhD, 412-624-5500, savitakhanna@pitt.edu
Scot King, DPT, scot.king@pitt.edu
About this study
Official title: 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.
- Conditions
- Skin Barrier Dysfunction, Healthy Volunteers
- Being tested
- Fermented Papaya Preparation (FPP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fermented Papaya Preparation (FPP)Dietary supplement
Immun'Age Fermented Papaya Preparation
| Study group | Role | What they receive |
|---|---|---|
| Fermented Papaya Preparation | Experimental | Fermented Papaya Preparation Supplement Receives: Dietary Supplement: Fermented Papaya Preparation (FPP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transepidermal Water Loss (TEWL)
9 anatomical sites. Unit g/m²/h
Measured: From enrollment to the end of FPP at 12 weeks.
Skin surface pH
9 anatomical sites.
Measured: From enrollment to the end of FPP at 12 weeks.
Skin surface temperature
9 anatomical sites. Unit Celsius
Measured: From enrollment to the end of FPP at 12 weeks.
Secondary outcomes (4)
Monocyte Inflammation Marker
CD16
Measured: From enrollment to the end of FPP at 12 weeks.
Glucose Levels
Unit mg/dL
Measured: From enrollment to the end of FPP at 12 weeks.
HbA1c Levels
Percentage
Measured: From enrollment to the end of FPP at 12 weeks.
Complete Blood Count (CBC)
Absolute Counts
Measured: From enrollment to the end of FPP at 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Barrier DysfunctionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Osato Research Institute
- Responsible party
- Principal investigator, Savita Khanna, University of Pittsburgh
- Investigators
- Savita Khanna, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725835
- Sponsor's protocol ID
- STUDY26010104
- Acronym
- FPP OSATO
- Status last verified
- Oct 2026
- First submitted
- 21 Jul 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No