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
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | The cream base formulation containing oil phase, Creagel EZ® 7 and Alphaflow® 20 | Daily skin application for the following 4 weeks at the same place according to the instruction |
| COMBINATION_PRODUCT | The cream base formulation containing oil phase, Creagel EZ® 7 and Alphaflow® 20 with additional growth factor EGF | Daily skin application for the following 4 weeks at the same place according to the instruction |
| BIOLOGICAL | The cream base formulation containing oil phase, Creagel EZ® 7 and Alphaflow® 20 with autologus PRF | Daily 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.