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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
20
Daily skin application for the following 4 weeks at the same place according to the instruction
Daily skin application for the following 4 weeks at the same place according to the instruction
Daily skin application for the following 4 weeks at the same place according to the instruction
Poznan University of Medical Sciences
Poznan, The Greater Poland, Poland
Skin water content
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.
Time frame: Baseline
Transepidermal water loss
Tewameter
Time frame: Baseline
Skin topography
Visioscan® VC98 and Visioline® VL650
Time frame: Baseline
Skin elasticity
Cutometer
Time frame: Baseline
Dermal Bioavailability
Tape-Stripping Method
Time frame: Baseline
Skin water content
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.
Time frame: After 1 week
Skin water content
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.
Time frame: After 2 weeks
Skin water content
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.
Time frame: After 4 weeks
Transepidermal water loss
Tewameter
Time frame: After 1 week
Transepidermal water loss
Tewameter
Time frame: After 2 weeks
Transepidermal water loss
Tewameter
Time frame: After 4 weeks
Skin topography
Visioscan® VC98 and Visioline® VL650
Time frame: After 4 weeks
Skin elasticity
Cutometer
Time frame: After 4 weeks
Dermal Bioavailability
Tape-Stripping Method
Time frame: After 4 weeks
Stability Evaluation of cream formulations
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.
Time frame: Baseline
Stability Evaluation of cream formulations
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.
Time frame: After 60 days
pH Measurement of cream formulations
The pH of the cosmetic emulsions was measured three times using the EcoSense® pH 10 pH/Temperature Meter, Pen Style (VMR International).
Time frame: Baseline
pH Measurement of cream formulations
The pH of the cosmetic emulsions was measured three times using the EcoSense® pH 10 pH/Temperature Meter, Pen Style (VMR International).
Time frame: After 12 weeks
Cream Viscosity Measurement
The viscosity of the cosmetic emulsions was measured three times using the RC02 rotational viscometer (Rheotec).
Time frame: Baseline
Light Scattering Stability Analysis
Stability analysis of the formulations was performed using the multiple light scattering method with the Turbiscan Lab Expert device (Formulaction SA).
Time frame: Baseline
Growth Factor Quantification in Cosmetic Formulations
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.
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Time frame: Baseline
Stability Testing Points
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.
Time frame: After 2 weeks
Stability Testing Points
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.
Time frame: After 4 weeks
Stability Testing Points
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.
Time frame: After 8 weeks
Stability Testing Points
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.
Time frame: After 12 weeks