Efficacy Processes of Aesthetic and Cosmetic Methods

NCT06755112 | Completed

• 1 other identifier: 37942/11-05-2021
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Study with biophysical methods and skin biopsies to evaluate the effect on the skin of healthy volunteers of

1. 1.cosmetic creams of Unisooth EG-28® mixture before and after Nd:YAG and
2. 2.the Unisooth EG-28® ingredient with iontophoresis and external application of cosmetic cream with active ingredient Olea vitae PLF®.

Conditions

Healthy

Keywords

Olea europaea stem cells; epilation; skin biopsies; efficacy; biophysical measurements; skin care; formulation

Outcome Measures

Primary Outcomes (5)

• Trans epidermal water loss (TEWL)

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

  2 weeks

• keratin hydration

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

  2 weeks

• melanin and skin erythema.

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

  2 weeks

• skin elasticity

  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 %.

  2 weeks

• Skin Biopsies

  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

  2 weeks

Secondary Outcomes (1)

• self assesment questionnaire

  2 months

Study Arms (2)

placebo cream

PLACEBO COMPARATOR

everyday using of placebo cream

Other: Placebo cream

active cream

ACTIVE COMPARATOR

everyday using of active cream

Other: active cream

Interventions

Placebo cream OTHER

Placebo cream application

placebo cream

active cream OTHER

Active cream application

active cream

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of West Attica: lead

Study Sites (1)

UNIWA

Aigáleo, Attica, 14423, Greece

Location

Study Officials

• ATHANASIA VARVARESOU, PROFESSOR

  UNIWA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Laboratory Teaching Stuff, Phd candidate

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: January 1, 2025
• Study Start: January 8, 2023
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)