NCT07079371

Brief 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 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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 18, 2025

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 23, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

July 23, 2025

Status Verified

June 1, 2025

Enrollment Period

7 months

First QC Date

July 14, 2025

Last Update Submit

July 14, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in TransEpidermal Water Loss (TEWL)

    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

    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

    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).

Study Arms (2)

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.

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.

Procedure: Micellar Water Application (With Rinse)

Interventions

Participants apply micellar water to the forehead once daily and leave it on the skin without rinsing for 21 days.

Micellar Water Application Without Rinsing

Participants apply micellar water to the forehead once daily and rinse it off after application for 21 days.

Micellar Water Application With Rinsing

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univerity of Split School of Medicine

Split, 21000, Croatia

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2025

First Posted

July 23, 2025

Study Start

June 18, 2025

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

July 23, 2025

Record last verified: 2025-06

Locations