NCT06755112: EPACM

Efficacy Processes of Aesthetic and Cosmetic Methods

Completed NA Last updated 1 January 2025

What this trial tests

NA trial testing Placebo cream in Healthy in 45 participants. Completed in 31 July 2023.

Timeline

8 January 2023

Primary endpoint
31 July 2023

31 July 2023

Quick facts

Lead sponsor	University of West Attica
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	basic science
Enrollment	45
Start date	8 January 2023
Primary completion	31 July 2023
Estimated completion	31 July 2023
Sites	1 location across Greece

Drugs / interventions tested

• Placebo cream
• active cream

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

University of West Attica

Who can join

Adults 18 to 65, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Clinical Measurement of Transepidermal Water Loss.
   Kundu D, Jayaraman A, Sen CK. · · 2026 · cited 4× · PMID 40476522 · DOI 10.1089/wound.2024.0148