Helichrysum Italicum Extract in Irritant Contact Dermatitis

June 23, 2026 updated by: University of Split, School of Medicine

Assessment of the Effect of Helichrysum Italicum Extract in Irritant Contact Dermatitis: A Randomized Controlled Clinical Trial

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.

Study Overview

Status

Recruiting

Conditions

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 Contact

Study Locations

  • Croatia
      • Split, Croatia, 21000
        • Recruiting
        • University of Split School of Medicine
        • Contact:

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • healthy volunteers who gave written informed consent

Exclusion Criteria:

  • skin disease
  • skin damage on measurement sites
  • use of corticosteroids, antihistamines and immunomodulators a month prior the inclusion and during the trial
  • pregnancy or breastfeeding
  • immunosuppression
  • allergic or irritant reactions to the constituents of the cream

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Helichrysum italicum Extract Cream
Participants will receive a topical emollient cream containing Helichrysum italicum extract applied to an SLS-treated skin site.
Other: Helichrysum italicum Extract Cream
Topical emollient cream containing Helichrysum italicum extract
Placebo Comparator: Placebo Cream
Participants will receive the same emollient cream base without Helichrysum italicum extract applied to an SLS-treated skin site.
Other: Placebo Cream
A moisturizing cream without Helichrysum italicum extract applied to the designated skin site.
No Intervention: Untreated Control Site
An SLS-treated skin site that will not receive any topical treatment and will serve as a control for natural skin barrier recovery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Transepidermal Water Loss (TEWL)
Time Frame: Baseline (prior to SLS application) and Days 1, 2, 3, 4, and 7 (change from baseline).
Skin barrier function will be assessed by measuring transepidermal water loss using a Tewameter TM 300 probe. Values will be expressed in g/m²/h
Baseline (prior to SLS application) and Days 1, 2, 3, 4, and 7 (change from baseline).
Change in Skin Hydration
Time Frame: Baseline (prior to SLS application) and Days 1, 2, 3, 4, and 7 (change from baseline).
Hydration of the stratum corneum will be assessed using a Corneometer CM 825 probe.
Baseline (prior to SLS application) and Days 1, 2, 3, 4, and 7 (change from baseline).
Change in Skin Erythema
Time Frame: Baseline (prior to SLS application) and Days 1, 2, 3, 4, and 7 (change from baseline).
Skin erythema will be assessed using a Mexameter MX 18 probe.
Baseline (prior to SLS application) and Days 1, 2, 3, 4, and 7 (change from baseline).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Split, School of Medicine

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 (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

June 23, 2026

First Submitted That Met QC Criteria

June 23, 2026

First Posted (Actual)

June 30, 2026

Study Record Updates

Last Update Posted (Actual)

June 30, 2026

Last Update Submitted That Met QC Criteria

June 23, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2181-198-03-04-26-0036

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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