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NCT Number: NCT07676253

Helichrysum Italicum Extract in Irritant Contact Dermatitis

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.

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Key information

Conditions

Skin Barrier Disruption and Recovery Dermatitis Dermatitis, Contact Dermatitis, Irritant Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Split School of Medicine

Split, 21000, Croatia

Location status: Recruiting

Location contact

Josipa Bukić

CONTACT

[email protected]

+385917933753

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Helichrysum italicum Extract Cream

Other

Topical emollient cream containing Helichrysum italicum extract

Placebo Cream

Other

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

Primary outcomes

  1. 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

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Josipa Bukić

CONTACT

[email protected]

+385917933753

Sponsors and collaborators

Lead sponsor

University of Split, School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 30, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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