NCT06755112

Efficacy Processes of Aesthetic and Cosmetic Methods

A Study With Biophysical Methods and Skin Biopsies to Evaluate the Effect on the Skin of Healthy Volunteers of Cosmetic Creams Before and After the Use of Nd:YAG Laser

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: University of West Attica · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Study with biophysical methods and skin biopsies to evaluate the effect on the skin of healthy volunteers of 1. cosmetic creams of Unisooth EG-28® mixture before and after Nd:YAG and 2. the Unisooth EG-28® ingredient with iontophoresis and external application of cosmetic cream with active ingredient Olea vitae PLF®. OBJECTIVE: To be investigated by approved non-invasive biophysical methods (Directive 2003/15/EC of the European Parliament and of the Council of 27 February 2003 amending Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products. Official Journal L 066, 11/03/2003 P. 0026 - 0035), such as transdermal water loss, erythema, pigmentation, keratin hydration (MPA 5 device), elasticity (Cutometer 575 device) and skin microtopography-thin line skin surface imaging (Skin Visoscan VC 98 and Skin Visiometer) and by minimally invasive methods such as skin biopsies, the effect on the skin of substances with a) anti-inflammatory action and b) antioxidant-anti-ageing action incorporated in cosmetic products when applied alone and/or in combination with other aesthetic approved methods with or without the use of devices used in Aesthetics such as Laser Nd:YAG, or diode laser, iontophoresis.

Detailed description

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 or/and in combination with laser treatments. The study will include efficacy tests (efficacy tests-claim substantiation) with biophysical methods in healthy volunteers of the above-mentioned bioactive substances incorporated in products when applied on their skin either with topical application or in combination with the use of machinery (iontophoresis) and the comparison of results between the methods used. Healthy male and female volunteers aged 18 to 65 years can participate in this study. Participants will apply either an active cream or a placebo cream to the inner surface of both arms twice daily (morning and evening) for a certain period. The study will measure transdermal water loss, erythema, pigmentation, and keratin hydration using the MPA 5 device before the beginning of the trial and at the end . 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. 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. Study was conducted at the Established Laboratory of Chemistry - Biochemistry - Cosmetology, Department of Biomedical Sciences, University of West Athens, Aegaleo Alsace Campus (Greece)

Conditions

• Healthy

Interventions

Type	Name	Description
OTHER	Placebo cream	Placebo cream application
OTHER	active cream	Active cream application

Timeline

• Start date: 2023-01-08
• Primary completion: 2023-07-31
• Completion: 2023-07-31
• First posted: 2025-01-01
• Last updated: 2025-01-01

Locations

1 site across 1 country: Greece