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Helichrysum Italicum Extract in Irritant Contact Dermatitis

NCT07676253 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-07-17

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of a topical cream containing Immortelle (Helichrysum italicum) extract in promoting skin barrier recovery and reducing signs of irritant contact dermatitis in healthy adult participants.

The main questions it aims to answer are:

* Does topical application of Helichrysum italicum extract improve skin barrier recovery following experimentally induced irritant contact dermatitis?
* Does the cream containing Helichrysum italicum extract reduce transepidermal water loss and erythema, and improve skin hydration compared to a standard moisturizing cream?
* Is the topical application of Helichrysum italicum extract safe and well tolerated?

Researchers will compare skin sites treated with a cream containing Helichrysum italicum extract, placebo-treated skin sites, and untreated skin sites to determine whether the addition of the extract provides additional benefits in skin barrier recovery.

Participants will:

* Undergo induction of irritant contact dermatitis using sodium lauryl sulfate (SLS) under occlusion.
* Apply a cream containing Helichrysum italicum extract to one designated skin site and a placebo cream to another designated skin site twice daily throughout the study period.
* Have an additional SLS-treated skin site left untreated to assess natural skin barrier recovery.
* Apply the cream containing Helichrysum italicum extract to a separate area of healthy, intact skin.
* Attend daily study visits for non-invasive assessments of skin barrier function, including transepidermal water loss, skin hydration, and erythema measurements.

Conditions

  • Skin Barrier Disruption and Recovery

Interventions

OTHER

Helichrysum italicum Extract Cream

Topical emollient cream containing Helichrysum italicum extract

OTHER

Placebo Cream

A moisturizing cream without Helichrysum italicum extract applied to the designated skin site.

Sponsors & Collaborators

  • University of Split, School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • Croatia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07676253 on ClinicalTrials.gov