AzTrials
AzTrials

Skin AgeingPhase 2NCT07359924

PRF in Face Care Cream.

A Phase 2 study testing The cream base formulation containing oil phase, Creagel EZ® 7 and Alphaflow® 20, The cream base formulation containing oil phase, Creagel EZ® 7 and Alphaflow® 20 with additional growth factor EGF and The cream base formulation containing oil phase, Creagel EZ® 7 and Alphaflow® 20 with autologus PRF in people with Skin Ageing, run by Poznan University of Medical Sciences at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Skin Ageing
What is being tested?
The cream base formulation containing oil phase, Creagel EZ® 7 and Alphaflow® 20, The cream base formulation containing oil phase, Creagel EZ® 7 and Alphaflow® 20 with additional growth factor EGF and The cream base formulation containing oil phase, Creagel EZ® 7 and Alphaflow® 20 with autologus PRF
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 sitePoland
Study dates
3 Feb 2022to 6 Feb 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Poland1 site
  • Poznan University of Medical Sciences

    Poznan, The Greater Poland, 60-812

Other trials in Poland

About this study

Official title: 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.

Conditions
Skin Ageing
Being tested
The cream base formulation containing oil phase, Creagel EZ® 7 and Alphaflow® 20, The cream base formulation containing oil phase, Creagel EZ® 7 and Alphaflow® 20 with additional growth factor EGF, The cream base formulation containing oil phase, Creagel EZ® 7 and Alphaflow® 20 with autologus PRF
Keywords
PRF, skin, cream, EGF

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The cream base formulation containing oil phase, Creagel EZ® 7 and Alphaflow® 20Combination 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 EGFCombination 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 PRFBiological

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

Study groups in NCT07359924
Study groupRoleWhat they receive
Formulation 1Placebo comparatorBase formulation
Receives: Combination Product: The cream base formulation containing oil phase, Creagel EZ® 7 and Alphaflow® 20
Formulation 2Active comparatorFormulation with growth factor EGF
Receives: Combination Product: The cream base formulation containing oil phase, Creagel EZ® 7 and Alphaflow® 20 with additional growth factor EGF
Formulation 3ExperimentalFormulation with PRF
Receives: Biological: The cream base formulation containing oil phase, Creagel EZ® 7 and Alphaflow® 20 with autologus PRF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

  2. Transepidermal water loss

    Tewameter

    Measured: Baseline

  3. Skin topography

    Visioscan® VC98 and Visioline® VL650

    Measured: Baseline

  4. Skin elasticity

    Cutometer

    Measured: Baseline

  5. Dermal Bioavailability

    Tape-Stripping Method

    Measured: Baseline

  6. 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.

    Measured: After 1 week

  7. 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.

    Measured: After 2 weeks

  8. 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.

    Measured: After 4 weeks

  9. Transepidermal water loss

    Tewameter

    Measured: After 1 week

  10. Transepidermal water loss

    Tewameter

    Measured: After 2 weeks

  11. Transepidermal water loss

    Tewameter

    Measured: After 4 weeks

  12. Skin topography

    Visioscan® VC98 and Visioline® VL650

    Measured: After 4 weeks

  13. Skin elasticity

    Cutometer

    Measured: After 4 weeks

  14. Dermal Bioavailability

    Tape-Stripping Method

    Measured: After 4 weeks

Secondary outcomes (11)
  1. 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.

    Measured: Baseline

  2. 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.

    Measured: After 60 days

  3. 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).

    Measured: Baseline

  4. 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).

    Measured: After 12 weeks

  5. Cream Viscosity Measurement

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

    Measured: Baseline

  6. 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).

    Measured: Baseline

  7. 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.

    Measured: Baseline

  8. 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.

    Measured: After 2 weeks

  9. 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.

    Measured: After 4 weeks

  10. 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.

    Measured: After 8 weeks

  11. 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.

    Measured: After 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2026
  2. Study start3 Feb 2022
  3. Primary completion8 Aug 2022
  4. Study completion6 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Factorial
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.
Masking
Single blind
Who is masked
Participant
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07359924
Sponsor's protocol ID
PUMS-308/18
Status last verified
Jan 2026
First submitted
13 Jan 2026
Last updated
22 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The datasets used and analyzed during the current study are available from the corresponding author upon reasonable request.

Publications

  • 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.

    PubMed 24889351
  • 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.

    PubMed 29707820
  • 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.

    PubMed 27233677
  • 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.

    PubMed 19089687
  • 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.

    PubMed 24448117
  • 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.

    PubMed 21740379
  • 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.

    PubMed 22507038

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing The cream base formulation containing oil phase, Creagel EZ® 7 and Alphaflow® 20, The cream base formulation containing oil phase, Creagel EZ® 7 and Alphaflow® 20 with additional growth factor EGF and The cream base formulation containing oil phase, Creagel EZ® 7 and Alphaflow® 20 with autologus PRF in people with Skin Ageing, run by Poznan University of Medical Sciences at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Skin water content (time frame: Baseline). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07359924, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.

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