Effect of FPP on Cutaneous Barrier Integrity

ConditionsSkin Barrier Dysfunction Healthy Volunteers

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age50-75

SponsorUniversity of Pittsburgh

About 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

Fermented Papaya Preparation (FPP)
Dietary supplement
Immun'Age Fermented Papaya Preparation

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: Fermented Papaya PreparationExperimental treatment 1 intervention

Trial outcomes