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
- Nov 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 startNov 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
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Fermented Papaya Preparation (FPP) Impact on Transepidermal Water Loss of Skin on Face, Arms, and Hands
- ClinicalTrials.gov ID
- NCT07725835
- Acronym / sponsor ID
- FPP OSATO / STUDY26010104
- Conditions
- Skin Barrier Dysfunction, Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Osato Research Institute
- Study start
- Nov 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fermented Papaya Preparation | Experimental | Dietary Supplement: Fermented Papaya Preparation (FPP)Fermented Papaya Preparation Supplement |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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%).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fermented Papaya Preparation (FPP)Immun'Age Fermented Papaya Preparation | Dietary supplement | Fermented Papaya Preparation |
Primary outcome
Transepidermal Water Loss (TEWL)
Time frame: From enrollment to the end of FPP at 12 weeks.
9 anatomical sites. Unit g/m²/h
Skin surface pH
Time frame: From enrollment to the end of FPP at 12 weeks.
9 anatomical sites.
Skin surface temperature
Time frame: From enrollment to the end of FPP at 12 weeks.
9 anatomical sites. Unit Celsius
4 secondary outcomes
Monocyte Inflammation Marker
Time frame: From enrollment to the end of FPP at 12 weeks.
Glucose Levels
Time frame: From enrollment to the end of FPP at 12 weeks.
HbA1c Levels
Time frame: From enrollment to the end of FPP at 12 weeks.
Complete Blood Count (CBC)
Time frame: From enrollment to the end of FPP at 12 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Scot King, DPT contact
Savita Khanna, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Savita Khanna, PhD (412-624-5500, savitakhanna@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transepidermal Water Loss (TEWL) (time frame: From enrollment to the end of FPP at 12 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.