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Completed

NCT Number: NCT06755112

Efficacy Processes of Aesthetic and Cosmetic Methods

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNIWA

Aigáleo, Attica, 14423, Greece

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Volunteer individuals aged 18 to 65 years, either sex
  • Written and informed consent
  • Healthy volunteers without skin disease or any other diseases (acute or chronic)

Exclusion criteria

  • Pregnancy, lactating, or planned pregnancy
  • People who use external application containing steroids for the treatment of skin disease more than one month
  • Participated in the same trial within six months from the interview
  • People with hypersensitive skin
  • Skin abnormalities such as severe acne, erythema, telangiectasia on the test site
  • Used the same or similar cosmetic (or pharmaceutical) on the test site within three months from the interview
  • Have peeling of skin or wrinkles removed within six months from the interview
  • Other unsuitable reasons for clinical trial based on the discretion of the investigator

Treatment and study plan

Placebo Cream

Other

Placebo cream application

Active Cream

Other

Active cream application

Primary outcomes

  1. Trans epidermal water loss (TEWL)

    Time frame: 2 weeks

    Tewameter MPA-5 Courage + Khazaka electronic GmbH (Germany) was used

  2. keratin hydration

    Time frame: 2 weeks

    Corneometer CM 825 Courage + Khazaka electronic GmbH (Germany) was used

  3. melanin and skin erythema.

    Time frame: 2 weeks

    Mexameter MPA-5 Courage + Khazaka electronic GmbH (Germany) was used

  4. skin elasticity

    Time frame: 2 weeks

    Cutometer MPA 580, Courage + Khazaka electronic GmbH (Germany) was used for skin elasticity parameters: R2: visco-elasticity in % (resistance to the mechanical force versus ability of recovery), R5: net elasticity in %: Ur/Ue = elastic part of the suction phase vs. immediate recovery during relaxation phase, R7: Ur/Uf proportion of the immediate recovery compared to the amplitude after suction in %.

  5. Skin Biopsies

    Time frame: 2 weeks

    Skin puncture biopsies (2.5-3.0 mm) were taken from the forearm of each volunteer. The samples were taken before treatment (Pre-treatment) D=0 and 14 days after laser and product application (Post treatment) D= 14, to all 12 volun-teers. The skin was cleaned with a providone-iodine solution, before taking the biopsy, and the area was anesthetized with a xylocaine solution with epineph-rine. A special cylindrical tool was used, which was rotated through the skin, to remove a small part of the skin, including deeper layers. The incision depth was up to the dermis. The biopsies were placed in numbered vials with formalin so-lution and then fixed for observation under the optical microscope. The goal was to observe the possible increase in the thickness of the epidermis, or the dermis, as well as the morphological observation of the structure of the dermis, in terms of collagen and elastin fibers. The dermis' thickness was measured from the start of the dermoepidermal synapse to the end o

Secondary outcomes

  1. self assesment questionnaire

    Time frame: 2 months

    Finally, forty-five female volunteers aged between 18-65 , phototypes II and III, according to Fitzpatrick classification, were included in the self-questionnaire study after the appropriate signed informed consent. The study was conducted during the years 2022-2023. Treated areas with active cream or placebo were left or right arm, randomly assigned .

Sponsors and collaborators

Lead sponsor

University of West Attica

Other

Registry information

Official study title

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

Acronym: EPACM

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 1, 2025
Registry last updated
Jan 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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