PRF in Face Care Cream.

NCT07359924 | Completed Phase 2

• 1 other identifier: PUMS-308/18
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Ageing

Keywords

PRF; skin; cream; EGF

Outcome Measures

Primary Outcomes (14)

• 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.

  Baseline

• Transepidermal water loss

  Tewameter

  Baseline

• Skin topography

  Visioscan® VC98 and Visioline® VL650

  Baseline

• Skin elasticity

  Cutometer

  Baseline

• Dermal Bioavailability

  Tape-Stripping Method

  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.

  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.

  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.

  After 4 weeks

• Transepidermal water loss

  Tewameter

  After 1 week

• Transepidermal water loss

  Tewameter

  After 2 weeks

• Transepidermal water loss

  Tewameter

  After 4 weeks

• Skin topography

  Visioscan® VC98 and Visioline® VL650

  After 4 weeks

• Skin elasticity

  Cutometer

  After 4 weeks

• Dermal Bioavailability

  Tape-Stripping Method

  After 4 weeks

Secondary Outcomes (11)

• Stability Evaluation of cream formulations

  Baseline

• Stability Evaluation of cream formulations

  After 60 days

• pH Measurement of cream formulations

  Baseline

• pH Measurement of cream formulations

  After 12 weeks

• Cream Viscosity Measurement

  Baseline

Study Arms (3)

Formulation 1

PLACEBO COMPARATOR

Base formulation

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

Formulation 2

ACTIVE COMPARATOR

Formulation with growth factor EGF

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

Formulation 3

EXPERIMENTAL

Formulation with PRF

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

Interventions

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

Formulation 1

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

Formulation 2

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

Formulation 3

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Poznan University of Medical Sciences

Poznan, The Greater Poland, 60-812, Poland

Location

Related Publications (8)

• 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.

  PMID: 24889351 RESULT

• 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.

  PMID: 29707820 RESULT

• 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

  RESULT

• 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.

  PMID: 27233677 RESULT

• 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.

  PMID: 19089687 RESULT

• 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.

  PMID: 24448117 RESULT

• 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.

  PMID: 21740379 RESULT

• 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.

  PMID: 22507038 RESULT

Study Officials

• Marzena Liliana Wyganowska, Prof.

  Departament of Periodontology and Oral Mucosa Diseases PUMS

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 22, 2026
• Study Start: February 3, 2022
• Primary Completion: August 8, 2022
• Study Completion: February 6, 2023
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: 6 month after publication
• Access Criteria: E-mail contact with corresponding author

Locations

PL (1)