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Trials / Completed

CompletedNCT07359924

PRF in Face Care Cream.

Application of Liquid Fraction of Platelet-rich Fibrin in Face Care Cream.

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
20 (actual)
Sponsor
Poznan University of Medical Sciences · Academic / Other
Sex
Female
Age
20 Years – 40 Years
Healthy volunteers
Accepted

Summary

The study evaluates the effectiveness of cosmetic preparations containing PRF, conducted through in vivo studies. Material and Methods: The study involved 20 healthy volunteers (aged 20-40) who received three identically packaged creams to be applied to specific facial areas. Formulation 1: base formulation (control), Formulation 2: base formulation with human epidermal growth factor (EGF), and Formulation 3: base formulation with platelet-rich fibrin (PRF). Volunteers applied the creams as directed for a period of four weeks. Skin assessments was conducted at baseline (week 0), and at weeks 1, 2, and 4. Trans-epidermal Water Loss (TEWL), skin hydration using corneometry to determine the moisture content of the stratum corneum, skin elasticity using a cutometer to measure the skin's ability to return to its original state after deformation, and dermal bioavailability were measured. EGF concentration in the stratum corneum will be measured using the tape-stripping method followed by HPLC (High-Performance Liquid Chroma-tography) analysis. Results: A significant decrease in TEWL was observed in formulations 2 and 3, indicating improved skin barrier function. Formulation 3 showed the highest increase in skin hy-dration, followed by formulation 2. Both formulations 2 and 3 demonstrated improvements in skin elasticity, with formulation 3 showing the greatest enhancement. EGF concentration in the stratum corneum increased over the four-week period, reaching equilibrium with the product concentration by week four. Con-clusion: The in vivo instrumental compatibility studies confirmed that the new cosmetic formulations containing EGF and PRF are safe and effective for human skin.

Conditions

Interventions

TypeNameDescription
COMBINATION_PRODUCTThe cream base formulation containing oil phase, Creagel EZ® 7 and Alphaflow® 20Daily skin application for the following 4 weeks at the same place according to the instruction
COMBINATION_PRODUCTThe cream base formulation containing oil phase, Creagel EZ® 7 and Alphaflow® 20 with additional growth factor EGFDaily skin application for the following 4 weeks at the same place according to the instruction
BIOLOGICALThe cream base formulation containing oil phase, Creagel EZ® 7 and Alphaflow® 20 with autologus PRFDaily skin application for the following 4 weeks at the same place according to the instruction

Timeline

Start date
2022-02-03
Primary completion
2022-08-08
Completion
2023-02-06
First posted
2026-01-22
Last updated
2026-01-22

Locations

1 site across 1 country: Poland

Source: ClinicalTrials.gov record NCT07359924. Inclusion in this directory is not an endorsement.