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Completed

NCT Number: NCT07359924

PRF in Face Care Cream.

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.

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Key information

Conditions

Skin Ageing

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Poznan University of Medical Sciences

Poznan, The Greater Poland, 60-812, Poland

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy volunteers with healthy skin, who sign an agreement for study participation

Exclusion criteria

  • systemic diseases, smoking, blood disorders, acute viral infections and skin inflammations, pregnancy, and breastfeeding.

Treatment and study plan

The cream base formulation containing oil phase, Creagel EZ® 7 and Alphaflow® 20

Combination Product

Daily skin application for the following 4 weeks at the same place according to the instruction

The cream base formulation containing oil phase, Creagel EZ® 7 and Alphaflow® 20 with additional growth factor EGF

Combination Product

Daily skin application for the following 4 weeks at the same place according to the instruction

The cream base formulation containing oil phase, Creagel EZ® 7 and Alphaflow® 20 with autologus PRF

Biological

Daily skin application for the following 4 weeks at the same place according to the instruction

Primary outcomes

  1. Skin water content

    Time frame: Baseline

    To measure the hydration of skin, an apparatus called a corneometer is used (Corneometer® CM 825 (Courage+Khazaka electronic GmbH)). It allows an accurate, reproducible and objective measurement of the hydration level of the stratum corneum of the skin. It records changes in electrical capacitance, consistent with the water content of the skin.

  2. Transepidermal water loss

    Time frame: Baseline

    Tewameter

  3. Skin topography

    Time frame: Baseline

    Visioscan® VC98 and Visioline® VL650

  4. Skin elasticity

    Time frame: Baseline

    Cutometer

  5. Dermal Bioavailability

    Time frame: Baseline

    Tape-Stripping Method

  6. Skin water content

    Time frame: After 1 week

    To measure the hydration of skin, an apparatus called a corneometer is used (Corneometer® CM 825 (Courage+Khazaka electronic GmbH)). It allows an accurate, reproducible and objective measurement of the hydration level of the stratum corneum of the skin. It records changes in electrical capacitance, consistent with the water content of the skin.

  7. Skin water content

    Time frame: After 2 weeks

    To measure the hydration of skin, an apparatus called a corneometer is used (Corneometer® CM 825 (Courage+Khazaka electronic GmbH)). It allows an accurate, reproducible and objective measurement of the hydration level of the stratum corneum of the skin. It records changes in electrical capacitance, consistent with the water content of the skin.

  8. Skin water content

    Time frame: After 4 weeks

    To measure the hydration of skin, an apparatus called a corneometer is used (Corneometer® CM 825 (Courage+Khazaka electronic GmbH)). It allows an accurate, reproducible and objective measurement of the hydration level of the stratum corneum of the skin. It records changes in electrical capacitance, consistent with the water content of the skin.

  9. Transepidermal water loss

    Time frame: After 1 week

    Tewameter

  10. Transepidermal water loss

    Time frame: After 2 weeks

    Tewameter

  11. Transepidermal water loss

    Time frame: After 4 weeks

    Tewameter

  12. Skin topography

    Time frame: After 4 weeks

    Visioscan® VC98 and Visioline® VL650

  13. Skin elasticity

    Time frame: After 4 weeks

    Cutometer

  14. Dermal Bioavailability

    Time frame: After 4 weeks

    Tape-Stripping Method

Secondary outcomes

  1. Stability Evaluation of cream formulations

    Time frame: Baseline

    The stability tests of the formulations were carried out immediately after preparation and after 60 days of storage at 40°C. From the obtained results, the arithmetic mean, and standard deviation were calculated. Each sample was tested three times, and the arithmetic mean, and standard deviation were computed from the results.

  2. Stability Evaluation of cream formulations

    Time frame: After 60 days

    The stability tests of the formulations were carried out immediately after preparation and after 60 days of storage at 40°C. From the obtained results, the arithmetic mean, and standard deviation were calculated. Each sample was tested three times, and the arithmetic mean, and standard deviation were computed from the results.

  3. pH Measurement of cream formulations

    Time frame: Baseline

    The pH of the cosmetic emulsions was measured three times using the EcoSense® pH 10 pH/Temperature Meter, Pen Style (VMR International).

  4. pH Measurement of cream formulations

    Time frame: After 12 weeks

    The pH of the cosmetic emulsions was measured three times using the EcoSense® pH 10 pH/Temperature Meter, Pen Style (VMR International).

  5. Cream Viscosity Measurement

    Time frame: Baseline

    The viscosity of the cosmetic emulsions was measured three times using the RC02 rotational viscometer (Rheotec).

  6. Light Scattering Stability Analysis

    Time frame: Baseline

    Stability analysis of the formulations was performed using the multiple light scattering method with the Turbiscan Lab Expert device (Formulaction SA).

  7. Growth Factor Quantification in Cosmetic Formulations

    Time frame: Baseline

    The quantification of the growth factor in the obtained cosmetic formulations was conducted using a high-performance liquid chromatograph (HPLC) Varian 920-LC (Agilent Technologies), equipped with an automatic injector and sample feeder. Both qualitative and quantitative methodologies were developed for the analysis of the cosmetic preparations.

  8. Stability Testing Points

    Time frame: After 2 weeks

    Stability tests for all formulations included four measurement points, analyzing the samples after 2, 4, 8, and 12 weeks of storage in climate chambers. The comprehensive testing ensured that the formulations maintained their desired properties and remained safe and effective for use throughout the study.

  9. Stability Testing Points

    Time frame: After 4 weeks

    Stability tests for all formulations included four measurement points, analyzing the samples after 2, 4, 8, and 12 weeks of storage in climate chambers. The comprehensive testing ensured that the formulations maintained their desired properties and remained safe and effective for use throughout the study.

  10. Stability Testing Points

    Time frame: After 8 weeks

    Stability tests for all formulations included four measurement points, analyzing the samples after 2, 4, 8, and 12 weeks of storage in climate chambers. The comprehensive testing ensured that the formulations maintained their desired properties and remained safe and effective for use throughout the study.

  11. Stability Testing Points

    Time frame: After 12 weeks

    Stability tests for all formulations included four measurement points, analyzing the samples after 2, 4, 8, and 12 weeks of storage in climate chambers. The comprehensive testing ensured that the formulations maintained their desired properties and remained safe and effective for use throughout the study.

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jan 22, 2026
Registry last updated
Jan 22, 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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