Helichrysum Italicum Extract in Irritant Contact Dermatitis

NCT07676253 | Recruiting

• 1 other identifier: 2181-198-03-04-26-0036
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Helichrysum italicum; Immortelle; Irritant contact dermatitis; Skin barrier recovery

Outcome Measures

Primary Outcomes (3)

• Change in Transepidermal Water Loss (TEWL)

  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

  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

  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).

Study Arms (3)

Helichrysum italicum Extract Cream

EXPERIMENTAL

Participants will receive a topical emollient cream containing Helichrysum italicum extract applied to an SLS-treated skin site.

Other: Helichrysum italicum Extract Cream

Placebo Cream

PLACEBO COMPARATOR

Participants will receive the same emollient cream base without Helichrysum italicum extract applied to an SLS-treated skin site.

Other: Placebo Cream

Untreated Control Site

NO INTERVENTION

An SLS-treated skin site that will not receive any topical treatment and will serve as a control for natural skin barrier recovery.

Interventions

Helichrysum italicum Extract Cream OTHER

Topical emollient cream containing Helichrysum italicum extract

Helichrysum italicum Extract Cream

Placebo Cream OTHER

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

Placebo Cream

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy volunteers who gave written informed consent

You may not qualify if:

• skin disease
• skin damage on measurement sites
• pregnancy or breastfeeding
• immunosuppression
• allergic or irritant reactions to the constituents of the cream

Sponsors & Collaborators

• University of Split, School of Medicine: lead

Study Sites (1)

University of Split School of Medicine

Split, 21000, Croatia

RECRUITING

MeSH Terms

Conditions

Dermatitis, Irritant

Condition Hierarchy (Ancestors)

Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Central Study Contacts

Josipa Bukić

CONTACT

+385917933753; jbukic@mefst.hr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized, placebo-controlled, intra-individual study in which each participant will receive all study conditions simultaneously on the forearms. Irritant contact dermatitis will be induced at designated skin sites using sodium lauryl sulfate (SLS) under occlusion. One SLS-treated site will be treated with a cream containing Helichrysum italicum extract, a second SLS-treated site will be treated with a placebo cream, and a third SLS-treated site will remain untreated to assess natural skin barrier recovery. In addition, the cream containing Helichrysum italicum extract will be applied to a separate area of healthy, intact skin to evaluate its effects and tolerability on non-irritated skin. The allocation of treatment sites will be determined according to the randomization protocol.

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 30, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)