Efficacy Processes of Aesthetic and Cosmetic Methods

NCT ID: NCT06755112

Last Updated: 2025-01-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-08
• Study Completion Date: 2023-07-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

placebo cream

everyday using of placebo cream

Group Type: PLACEBO_COMPARATOR

Placebo cream

Intervention Type: OTHER

Placebo cream application

active cream

everyday using of active cream

Group Type: ACTIVE_COMPARATOR

active cream

Intervention Type: OTHER

Active cream application

Interventions

Placebo cream

Placebo cream application

Intervention Type: OTHER

active cream

Active cream application

Intervention Type: OTHER

Eligibility Criteria

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)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of West Attica

OTHER

Sponsor Role: lead

Responsible Party

Vasiliki Gardiki

Laboratory Teaching Stuff, Phd candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ATHANASIA VARVARESOU, PROFESSOR

Role: STUDY_DIRECTOR

UNIWA

Locations

UNIWA

Aigáleo, Attica, Greece

Countries

Greece

Other Identifiers

37942/11-05-2021

Identifier Type: -

Identifier Source: org_study_id