Skin Ageing
Conditions
Keywords
PRF, skin, cream, EGF
Brief 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.
Interventions
COMBINATION_PRODUCTThe 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_PRODUCTThe 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
BIOLOGICALThe 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
Sponsors
Poznan University of Medical Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Every patients have got identically looking boxes with different creams formulation, signed by following numbers and the instruction for specific application. Every patient received the same instruction.
Intervention model description
Patients received three uniformly appearing creams with instruc-tions for application on specific facial areas every morning and evening. Skin reassessment was conducted after 1, 2, and 4 weeks from the start of application. During the four weeks of the study, baseline measurements (elasticity, hydration and transepidermal water loss) were taken weekly, with skin topography and mac-rosculpture additionally examined in weeks 0 and 4.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin water content | 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. |
| Transepidermal water loss | Baseline | Tewameter |
| Skin topography | Baseline | Visioscan® VC98 and Visioline® VL650 |
| Skin elasticity | Baseline | Cutometer |
| Dermal Bioavailability | Baseline | Tape-Stripping Method |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stability Evaluation of cream formulations | 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. |
| pH Measurement of cream formulations | Baseline | The pH of the cosmetic emulsions was measured three times using the EcoSense® pH 10 pH/Temperature Meter, Pen Style (VMR International). |
| Cream Viscosity Measurement | Baseline | The viscosity of the cosmetic emulsions was measured three times using the RC02 rotational viscometer (Rheotec). |
| Light Scattering Stability Analysis | Baseline | Stability analysis of the formulations was performed using the multiple light scattering method with the Turbiscan Lab Expert device (Formulaction SA). |
| Growth Factor Quantification in Cosmetic Formulations | 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. |
| Stability Testing Points | 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. |
Countries
Poland
Contacts
STUDY_CHAIRMarzena Liliana Wyganowska, Prof.
Departament of Periodontology and Oral Mucosa Diseases PUMS
Outcome results
None listed