Effects of Micellar Water Application on Skin Barrier Integrity, Hydration, and Erythema in Healthy SkinNCT07079371
Micellar Water and the Skin Barrier: Comparing Rinsing vs. Non-Rinsing Application
A study testing Micellar Water Application (No Rinse) and Micellar Water Application (With Rinse) in people with Effects of Micellar Water Application on Skin Barrier Integrity, Hydration, and Erythema in Healthy Skin, run by University of Split, School of Medicine at 1 site in Croatia.
Trial summary
The goal of this clinical trial is to assess how micellar water affects the skin barrier in healthy adult volunteers. The main questions it aims to answer are: Does leaving micellar water on the skin affect skin barrier function differently than rinsing it off? Are there measurable differences in transepidermal water… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Effects of Micellar Water Application on Skin Barrier Integrity, Hydration, and Erythema in Healthy Skin
- What is being tested?
- Micellar Water Application (No Rinse) and Micellar Water Application (With Rinse)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCroatia
- Study dates
- 18 Jun 2025to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy adult volunteers aged 18 years and older. Willingness and ability to comply with study procedures. Signed informed consent indicating understanding of study participation, rights, and potential risks and benefits. No current skin diseases or conditions at the test site. Ability to attend all study visits and follow instructions
Who cannot join
- Participants with skin diseases, skin cancers, or sun damage at the test site will be excluded. Use of immunomodulators, corticosteroids, or antihistamines within 30 days prior to the study start is exclusionary. Application of emollient creams within 3 days before the trial is not permitted. Other exclusion criteria include protocol non-compliance, excessive exposure to natural or artificial ultraviolet radiation, pregnancy or lactation, history of vitiligo, melasma, or other hyperpigmentation or photosensitive disorders, immunosuppression, and allergy to any ingredient of the micellar solution used in the intervention. Before starting the study, participants will be asked if they have ever experienced adverse reactions to any components of the micellar solution.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Effect of Micellar Solution on Measures of Skin Barrier Function
The goal of this clinical trial is to assess how micellar water affects the skin barrier in healthy adult volunteers. The main questions it aims to answer are:
- Does leaving micellar water on the skin affect skin barrier function differently than rinsing it off?
- Are there measurable differences in transepidermal water loss (TEWL), skin hydration, and erythema between the two application methods?
Read more
Researchers will compare the effects of micellar water left on the skin versus rinsed off after application.
Participants will:
- Be randomly assigned to one of two groups
- Apply micellar water to their forehead once daily for 21 days
- Either leave the micellar water on or rinse it off, depending on their group
- Undergo non-invasive measurements of TEWL, skin hydration, and erythema before and after the intervention
- Being tested
- Micellar Water Application (No Rinse), Micellar Water Application (With Rinse)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micellar Water Application (No Rinse)Procedure or surgery
Participants apply micellar water to the forehead once daily and leave it on the skin without rinsing for 21 days.
Micellar Water Application (With Rinse)Procedure or surgery
Participants apply micellar water to the forehead once daily and rinse it off after application for 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Micellar Water Application Without Rinsing | Experimental | Participants apply micellar water to the forehead once daily and leave it on the skin without rinsing. Skin barrier function is assessed before and after 21 days of application. Receives: Procedure: Micellar Water Application (No Rinse) |
| Micellar Water Application With Rinsing | Experimental | Participants apply micellar water to the forehead once daily and rinse it off after application. Skin barrier function is assessed before and after 21 days of application. Receives: Procedure: Micellar Water Application (With Rinse) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in TransEpidermal Water Loss (TEWL)
Measurement of transepidermal water loss on the forehead to assess skin barrier function.
Measured: Four measurements total: one at baseline (before application), and one at the start of each week during the 3-week intervention (Days 0, 7, 14, and 21).
Change in Skin Hydration
Measurement of skin hydration levels on the forehead before and after micellar water application.
Measured: Four measurements total: one at baseline (before application), and one at the start of each week during the 3-week intervention (Days 0, 7, 14, and 21).
Change in Erythema
Assessment of skin redness (erythema) on the forehead before and after of micellar water application.
Measured: Four measurements total: one at baseline (before application), and one at the start of each week during the 3-week intervention (Days 0, 7, 14, and 21).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start18 Jun 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effects of Micellar Water Application on Skin Barrier Integrity, Hydration, and Erythema in Healthy SkinStudies 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
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Split, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07079371
- Sponsor's protocol ID
- 2181-198-03-04-25-0065
- Status last verified
- Jun 2025
- First submitted
- 14 Jul 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effect of Micellar Solution on Measures of Skin Barrier Function
- ClinicalTrials.gov ID
- NCT07079371
- Acronym / sponsor ID
- 2181-198-03-04-25-0065
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Split, School of MedicineUniversity, hospital or other
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 23 Jul 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.
The goal of this clinical trial is to assess how micellar water affects the skin barrier in healthy adult volunteers. The main questions it aims to answer are:
- Does leaving micellar water on the skin affect skin barrier function differently than rinsing it off?
- Are there measurable differences in transepidermal water loss (TEWL), skin hydration, and erythema between the two application methods?
Researchers will compare the effects of micellar water left on the skin versus rinsed off after application.
Participants will:
- Be randomly assigned to one of two groups
- Apply micellar water to their forehead once daily for 21 days
- Either leave the micellar water on or rinse it off, depending on their group
- Undergo non-invasive measurements of TEWL, skin hydration, and erythema before and after the intervention
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Micellar Water Application Without Rinsing | Experimental | Procedure: Micellar Water Application (No Rinse)Participants apply micellar water to the forehead once daily and leave it on the skin without rinsing. Skin barrier function is assessed before and after 21 days of application. |
| Micellar Water Application With Rinsing | Experimental | Procedure: Micellar Water Application (With Rinse)Participants apply micellar water to the forehead once daily and rinse it off after application. Skin barrier function is assessed before and after 21 days of application. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adult volunteers aged 18 years and older. Willingness and ability to comply with study procedures. Signed informed consent indicating understanding of study participation, rights, and potential risks and benefits. No current skin diseases or conditions at the test site. Ability to attend all study visits and follow instructions
Key exclusion criteria (1 listed)
- Participants with skin diseases, skin cancers, or sun damage at the test site will be excluded. Use of immunomodulators, corticosteroids, or antihistamines within 30 days prior to the study start is exclusionary. Application of emollient creams within 3 days before the trial is not permitted. Other exclusion criteria include protocol non-compliance, excessive exposure to natural or artificial ultraviolet radiation, pregnancy or lactation, history of vitiligo, melasma, or other hyperpigmentation or photosensitive disorders, immunosuppression, and allergy to any ingredient of the micellar solution used in the intervention. Before starting the study, participants will be asked if they have ever experienced adverse reactions to any components of the micellar solution.
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 |
|---|---|---|
| Micellar Water Application (No Rinse)Participants apply micellar water to the forehead once daily and leave it on the skin without rinsing for 21 days. | Procedure or surgery | Micellar Water Application Without Rinsing |
| Micellar Water Application (With Rinse)Participants apply micellar water to the forehead once daily and rinse it off after application for 21 days. | Procedure or surgery | Micellar Water Application With Rinsing |
Primary outcome
Change in TransEpidermal Water Loss (TEWL)
Time frame: Four measurements total: one at baseline (before application), and one at the start of each week during the 3-week intervention (Days 0, 7, 14, and 21).
Measurement of transepidermal water loss on the forehead to assess skin barrier function.
Change in Skin Hydration
Time frame: Four measurements total: one at baseline (before application), and one at the start of each week during the 3-week intervention (Days 0, 7, 14, and 21).
Measurement of skin hydration levels on the forehead before and after micellar water application.
Change in Erythema
Time frame: Four measurements total: one at baseline (before application), and one at the start of each week during the 3-week intervention (Days 0, 7, 14, and 21).
Assessment of skin redness (erythema) on the forehead before and after of micellar water application.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micellar Water Application (No Rinse) and Micellar Water Application (With Rinse) in people with Effects of Micellar Water Application on Skin Barrier Integrity, Hydration, and Erythema in Healthy Skin, run by University of Split, School of Medicine at 1 site in Croatia.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 23 Jul 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 Croatia. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in TransEpidermal Water Loss (TEWL) (time frame: Four measurements total: one at baseline (before application), and one at the start of each week during the 3-week intervention (Days 0, 7, 14, and 21).). The study lists 3 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 23 Jul 2025.