Procedures of effectiveness of aesthetic and cosmetic methods

ISRCTN	ISRCTN11785773
DOI	https://doi.org/10.1186/ISRCTN11785773
Secondary identifying numbers	CPMS37942

Submission date: 16/12/2024
Registration date: 18/12/2024
Last edited: 18/12/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Skin and Connective Tissue Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
This study aims to evaluate the effects of certain cosmetic creams on the skin of healthy volunteers. Researchers will use biophysical methods and skin biopsies to assess the impact of these creams, both alone and in combination with laser treatments.

Who can participate?
Healthy male and female volunteers aged 18 to 65 years can participate in this study.

What does the study involve?
Participants will apply either an active cream or a placebo cream to the inner surface of both arms twice daily (morning and evening) for two weeks. The study will measure transdermal water loss, erythema, pigmentation, and keratin hydration using the MPA 5 device at Day 1 and Day 14. Elasticity will be measured using the Cutometer 575 device at the same time points. Additionally, small skin biopsies will be taken before starting the cream application and after 14 days to assess collagen improvement.

What are the possible benefits and risks of participating?
The study aims to demonstrate the effectiveness of the active ingredients in the cosmetic formulations. The results will help understand how these ingredients and treatments affect the skin. While the non-invasive tests are safe, the skin biopsies are minimally invasive and carry a small risk of discomfort or minor complications.

Where is the study run from?
Established Laboratory of Chemistry - Biochemistry - Cosmetology, Department of Biomedical Sciences, University of West Athens, Aegaleo Alsace Campus (Greece)

When is study starting and how long is it expected to run for?
November 2021 to July 2023

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Prof. Varvaresou Athanasia
avarvares@uniwa.gr

Contact information

Ms VASILIKI GARDIKI
Public, Principal Investigator

Agiou Spyridonos 28
Aigaleo
14423
Greece

ORCID ID	0000-0002-5706-3892
Phone	+30 6944584257
Email	vgardiki@uniwa.gr

Prof ATHANASIA VARVARESOU
Scientific

Agiou Spyridonos 28
Aigaleo
14423
Greece

ORCID ID	0000-0002-6932-8763
Phone	+30 2105385887
Email	avarvares@uniwa.gr

Study information

Study design	Randomized double blind placebo controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Laboratory
Study type	Efficacy
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet
Scientific title	Procedures of effectiveness of aesthetic and cosmetic methods
Study acronym	PEACM
Study objectives	Study with biophysical methods and skin biopsies to evaluate the effect on the skin of healthy volunteers of a) cosmetic creams of Unisooth EG-28® mixture before and after Nd:YAG or Diode laser or microcrystal dermabrasion or dermaroller and b) the Unisooth EG-28® ingredient with iontophoresis device and external application of cosmetic cream with active ingredient Olea vitae PLF®.
Ethics approval(s)	Approved 05/11/2021, UNIWA RESEARCH ETHICS COMMITTEE (Agiou Spyridonos 28, Aigaleo, 12243, Greece; +30 2105387294; ethics@uniwa.gr), ref: 37942/05-11-2021
Health condition(s) or problem(s) studied	Skin condition in healthy volunteers
Intervention	Group 1: Used OLEA VITAE™ 02 cream. Group 2: Used placebo cream. Intervention: Each participant received a coded vessel containing 70 g of either the active cream or placebo cream, without indication of its contents. Application: Participants applied the cream to the inner surface of both arms twice daily (morning and evening) for two weeks. Instructions: Participants were instructed not to apply their test cream in the twelve hours prior to the baseline visit. Total Duration of Intervention: 2 weeks. Follow-Up: Skin biopsies were performed at baseline (Day 0) and after 14 days of treatment (Day 14).
Intervention type	Supplement
Primary outcome measure	1. Transdermal water loss is measured using Tewameter MPA-5 at Day 0 and Day 14 2. Erythema is measured using Mexameter MPA-5 at Day 0 and Day 14 3. Pigmentation is measured using Mexameter MPA-5 at Day 0 and Day 14 4. Keratin hydration is measured using Corneometer CM 825 at Day 0 and Day 14 5. Elasticity is measured using Cutometer MPA 580 at Day 0 and Day 14 6. Collagen improvement is measured using skin biopsy at Day 0 and Day 14
Secondary outcome measures	Satisfaction and product tolerability measured using a questionnaire at the end of the treatment
Overall study start date	05/11/2021
Completion date	31/07/2023

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	Both
Target number of participants	45
Total final enrolment	45
Key inclusion criteria	1. Volunteer individuals aged 18 to 65 years, either sex 2. Written and informed consent 3. Healthy volunteers without skin disease or any other diseases (acute or chronic)
Key exclusion criteria	1. Pregnancy, lactating, or planned pregnancy 2. People who use external application containing steroids for the treatment of skin disease more than one month 3. Participated in the same trial within six months from the interview 4. People with hypersensitive skin 5. Skin abnormalities such as severe acne, erythema, telangiectasia on the test site 6. Used the same or similar cosmetic (or pharmaceutical) on the test site within three months from the interview 7. Have peeling of skin or wrinkles removed within six months from the interview 8. Other unsuitable reasons for clinical trial based on the discretion of the investigator
Date of first enrolment	01/09/2022
Date of final enrolment	30/12/2022

Locations

Countries of recruitment

Greece

Study participating centre

ESTABLISHED LABORATORY OF CHEMISTRY - BIOCHEMISTRY - COSMETOLOGY, DEPARTMENT OF BIOMEDICAL SCIENCES, UNIVERSITY OF WEST ATHENS, AEGALEO ALSACE CAMPUS

Agiou Spyridonos 28
Aigaleo
12243
Greece

Sponsor information

UNIWA
University/education

Agiou Spyridonos 28
Aigaleo
14423
Greece

Phone	+30 2105385887
Email	ethics@uniwa.gr
Website	https://www.uniwa.gr

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date	30/12/2024
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	Planned publication in a peer-reviewed journal
IPD sharing plan	The datasets generated during and/or analyzed during the current study are not expected to be made available due to university policy

Editorial Notes

18/12/2024: Trial's existence confirmed by UNIWA RESEARCH ETHICS COMMITTEE.