- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07079371
- Original Trial
Micellar Water and the Skin Barrier: Comparing Rinsing vs. Non-Rinsing Application
July 14, 2025 updated by: University of Split, School of Medicine
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?
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 Overview
Status
Active, not recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Split, Croatia, 21000
- Univerity of Split School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Micellar Water Application Without Rinsing
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.
|
Participants apply micellar water to the forehead once daily and leave it on the skin without rinsing for 21 days.
|
|
Experimental: Micellar Water Application With Rinsing
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.
|
Participants apply micellar water to the forehead once daily and rinse it off after application for 21 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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
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.
|
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
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.
|
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).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 18, 2025
Primary Completion (Estimated)
January 1, 2026
Study Completion (Estimated)
January 1, 2026
Study Registration Dates
First Submitted
July 14, 2025
First Submitted That Met QC Criteria
July 14, 2025
First Posted (Actual)
July 23, 2025
Study Record Updates
Last Update Posted (Actual)
July 23, 2025
Last Update Submitted That Met QC Criteria
July 14, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2181-198-03-04-25-0065
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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