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NCT Number: NCT07725835

Effect of FPP on Cutaneous Barrier Integrity

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.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McGowan Institute for Regenerative Medicine

Pittsburgh, Pennsylvania, 15219, United States

Location contact

Savita Khanna, PhD

CONTACT

[email protected]

412-624-5500

Savita Khanna, PhD

PRINCIPAL_INVESTIGATOR

Scot King, DPT

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Fermented Papaya Preparation (FPP)

Dietary Supplement

Immun'Age Fermented Papaya Preparation

Primary outcomes

  1. Transepidermal Water Loss (TEWL)

    Time frame: From enrollment to the end of FPP at 12 weeks.

    9 anatomical sites. Unit g/m²/h

  2. Skin surface pH

    Time frame: From enrollment to the end of FPP at 12 weeks.

    9 anatomical sites.

  3. Skin surface temperature

    Time frame: From enrollment to the end of FPP at 12 weeks.

    9 anatomical sites. Unit Celsius

Secondary outcomes

  1. Monocyte Inflammation Marker

    Time frame: From enrollment to the end of FPP at 12 weeks.

    CD16

  2. Glucose Levels

    Time frame: From enrollment to the end of FPP at 12 weeks.

    Unit mg/dL

  3. HbA1c Levels

    Time frame: From enrollment to the end of FPP at 12 weeks.

    Percentage

  4. Complete Blood Count (CBC)

    Time frame: From enrollment to the end of FPP at 12 weeks.

    Absolute Counts

Study contacts

Contact information is provided by the study sponsor or research team.

Savita Khanna, PhD

CONTACT

[email protected]

412-624-5500

Scot King, DPT

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Osato Research Institute

Registry information

Official study title

Pilot Study of Fermented Papaya Preparation (FPP) Impact on Transepidermal Water Loss of Skin on Face, Arms, and Hands

Acronym: FPP OSATO

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 24, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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