- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07359924
PRF in Face Care Cream.
January 13, 2026 updated by: Poznan University of Medical Sciences
Application of Liquid Fraction of Platelet-rich Fibrin 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Combination product: The cream base formulation containing oil phase, Creagel EZ® 7 and Alphaflow® 20
- Combination product: The cream base formulation containing oil phase, Creagel EZ® 7 and Alphaflow® 20 with additional growth factor EGF
- Biological: The cream base formulation containing oil phase, Creagel EZ® 7 and Alphaflow® 20 with autologus PRF
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
The Greater Poland
-
Poznan, The Greater Poland, Poland, 60-812
- Poznan University of Medical Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Formulation 1
Base formulation
|
Daily skin application for the following 4 weeks at the same place according to the instruction
|
|
Active Comparator: Formulation 2
Formulation with growth factor EGF
|
Daily skin application for the following 4 weeks at the same place according to the instruction
|
|
Experimental: Formulation 3
Formulation with PRF
|
Daily skin application for the following 4 weeks at the same place according to the instruction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Skin elasticity
Time Frame: Baseline
|
Cutometer
|
Baseline
|
|
Transepidermal water loss
Time Frame: Baseline
|
Tewameter
|
Baseline
|
|
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.
|
Baseline
|
|
Skin topography
Time Frame: Baseline
|
Visioscan® VC98 and Visioline® VL650
|
Baseline
|
|
Dermal Bioavailability
Time Frame: Baseline
|
Tape-Stripping Method
|
Baseline
|
|
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.
|
After 1 week
|
|
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.
|
After 2 weeks
|
|
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.
|
After 4 weeks
|
|
Transepidermal water loss
Time Frame: After 1 week
|
Tewameter
|
After 1 week
|
|
Transepidermal water loss
Time Frame: After 2 weeks
|
Tewameter
|
After 2 weeks
|
|
Transepidermal water loss
Time Frame: After 4 weeks
|
Tewameter
|
After 4 weeks
|
|
Skin topography
Time Frame: After 4 weeks
|
Visioscan® VC98 and Visioline® VL650
|
After 4 weeks
|
|
Skin elasticity
Time Frame: After 4 weeks
|
Cutometer
|
After 4 weeks
|
|
Dermal Bioavailability
Time Frame: After 4 weeks
|
Tape-Stripping Method
|
After 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline
|
|
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.
|
After 60 days
|
|
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).
|
Baseline
|
|
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).
|
After 12 weeks
|
|
Cream Viscosity Measurement
Time Frame: Baseline
|
The viscosity of the cosmetic emulsions was measured three times using the RC02 rotational viscometer (Rheotec).
|
Baseline
|
|
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).
|
Baseline
|
|
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.
|
Baseline
|
|
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.
|
After 2 weeks
|
|
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.
|
After 4 weeks
|
|
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.
|
After 8 weeks
|
|
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.
|
After 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Marzena Liliana Wyganowska, Prof., Departament of Periodontology and Oral Mucosa Diseases PUMS
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Dohan Ehrenfest DM, de Peppo GM, Doglioli P, Sammartino G. Slow release of growth factors and thrombospondin-1 in Choukroun's platelet-rich fibrin (PRF): a gold standard to achieve for all surgical platelet concentrates technologies. Growth Factors. 2009 Feb;27(1):63-9. doi: 10.1080/08977190802636713.
- Trojahn C, Dobos G, Schario M, Ludriksone L, Blume-Peytavi U, Kottner J. Relation between skin micro-topography, roughness, and skin age. Skin Res Technol. 2015 Feb;21(1):69-75. doi: 10.1111/srt.12158. Epub 2014 Jun 3.
- Dabrowska M, Mielcarek A, Nowak I. Evaluation of sex-related changes in skin topography and structure using innovative skin testing equipment. Skin Res Technol. 2018 Nov;24(4):614-620. doi: 10.1111/srt.12473. Epub 2018 Apr 29.
- 12. Zalewska A., Kowalik J., Grubecki I., Application of turbiscan lab to study the effect of emulsifier content on the stability of plant origin dispersion. Chem. Process Eng. 2019; 40(4): 399-409
- Gardien KL, Baas DC, de Vet HC, Middelkoop E. Transepidermal water loss measured with the Tewameter TM300 in burn scars. Burns. 2016 Nov;42(7):1455-1462. doi: 10.1016/j.burns.2016.04.018. Epub 2016 May 24.
- Arshdeep; Kumaran MS. Platelet-rich plasma in dermatology: boon or a bane? Indian J Dermatol Venereol Leprol. 2014 Jan-Feb;80(1):5-14. doi: 10.4103/0378-6323.125467.
- Dohan Ehrenfest DM, Bielecki T, Mishra A, Borzini P, Inchingolo F, Sammartino G, Rasmusson L, Everts PA. In search of a consensus terminology in the field of platelet concentrates for surgical use: platelet-rich plasma (PRP), platelet-rich fibrin (PRF), fibrin gel polymerization and leukocytes. Curr Pharm Biotechnol. 2012 Jun;13(7):1131-7. doi: 10.2174/138920112800624328.
- Feingold KR, Denda M. Regulation of permeability barrier homeostasis. Clin Dermatol. 2012 May-Jun;30(3):263-8. doi: 10.1016/j.clindermatol.2011.08.008.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 3, 2022
Primary Completion (Actual)
August 8, 2022
Study Completion (Actual)
February 6, 2023
Study Registration Dates
First Submitted
January 13, 2026
First Submitted That Met QC Criteria
January 13, 2026
First Posted (Actual)
January 22, 2026
Study Record Updates
Last Update Posted (Actual)
January 22, 2026
Last Update Submitted That Met QC Criteria
January 13, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The datasets used and analyzed during the current study are available from the corresponding author upon reasonable request.
IPD Sharing Time Frame
6 month after publication
IPD Sharing Access Criteria
E-mail contact with corresponding author
IPD Sharing Supporting Information Type
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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