HealthyEPACMNCT06755112
Efficacy Processes of Aesthetic and Cosmetic Methods
A study testing active cream in people with Healthy, run by University of West Attica at 1 site in Greece.
Trial 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®. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- active cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteGreece
- Study dates
- 8 Jan 2023to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
Study with biophysical methods and skin biopsies to evaluate the effect on the skin of healthy volunteers of
- cosmetic creams of Unisooth EG-28® mixture before and after Nd:YAG and
- 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.
Read the 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
- Being tested
- Placebo cream, active cream
- Keywords
- Olea europaea stem cells, epilation, skin biopsies, efficacy, biophysical measurements, skin care, formulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo creamOther
Placebo cream application
active creamOther
Active cream application
| Study group | Role | What they receive |
|---|---|---|
| placebo cream | Placebo comparator | everyday using of placebo cream Receives: Other: Placebo cream |
| active cream | Active comparator | everyday using of active cream Receives: Other: active cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trans epidermal water loss (TEWL)
Tewameter MPA-5 Courage + Khazaka electronic GmbH (Germany) was used
Measured: 2 weeks
keratin hydration
Corneometer CM 825 Courage + Khazaka electronic GmbH (Germany) was used
Measured: 2 weeks
melanin and skin erythema.
Mexameter MPA-5 Courage + Khazaka electronic GmbH (Germany) was used
Measured: 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 %.
Measured: 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
Measured: 2 weeks
Secondary outcomes (1)
self assesment questionnaire
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 .
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start8 Jan 2023
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of West Attica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vasiliki Gardiki, University of West Attica
- Investigators
- ATHANASIA VARVARESOU, PROFESSOR, Study director, UNIWA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755112
- Sponsor's protocol ID
- 37942/11-05-2021
- Acronym
- EPACM
- Status last verified
- Dec 2024
- First submitted
- 22 Dec 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: University policy
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06755112
- Acronym / sponsor ID
- EPACM / 37942/11-05-2021
- Conditions
- Healthy
- Keywords
- Olea europaea stem cells, epilation, skin biopsies, efficacy, biophysical measurements, skin care, formulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of West AtticaUniversity, hospital or other
- Study start
- 8 Jan 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 1 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study with biophysical methods and skin biopsies to evaluate the effect on the skin of healthy volunteers of
- cosmetic creams of Unisooth EG-28® mixture before and after Nd:YAG and
- 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)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo cream | Placebo comparator | Other: Placebo creameveryday using of placebo cream |
| active cream | Active comparator | Other: active creameveryday using of active cream |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo creamPlacebo cream application | Other | placebo cream |
| active creamActive cream application | Other | active cream |
Primary outcome
Trans epidermal water loss (TEWL)
Time frame: 2 weeks
Tewameter MPA-5 Courage + Khazaka electronic GmbH (Germany) was used
keratin hydration
Time frame: 2 weeks
Corneometer CM 825 Courage + Khazaka electronic GmbH (Germany) was used
melanin and skin erythema.
Time frame: 2 weeks
Mexameter MPA-5 Courage + Khazaka electronic GmbH (Germany) was used
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 %.
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
1 secondary outcome
self assesment questionnaire
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
- Individual participant dataSharing planned: No. University policy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ATHANASIA VARVARESOU, PROFESSOR study director
UNIWA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active cream in people with Healthy, run by University of West Attica at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trans epidermal water loss (TEWL) (time frame: 2 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2025.