Helichrysum Italicum Extract in Irritant Contact Dermatitis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity of Split, School of Medicine

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

healthy volunteers who gave written informed consent

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Helichrysum italicum Extract Cream

    Other intervention

    Topical emollient cream containing Helichrysum italicum extract

  • Placebo Cream

    Other intervention

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

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Helichrysum italicum Extract CreamExperimental treatment 1 intervention
Group B: Placebo CreamPlacebo comparator 1 intervention
Group C: Untreated Control SiteNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline (prior to SLS application) and Days 1, 2, 3, 4, and 7 (change from baseline).
2

Change in Skin Hydration

Hydration of the stratum corneum will be assessed using a Corneometer CM 825 probe.

Time frame
Baseline (prior to SLS application) and Days 1, 2, 3, 4, and 7 (change from baseline).
3

Change in Skin Erythema

Skin erythema will be assessed using a Mexameter MX 18 probe.

Time frame
Baseline (prior to SLS application) and Days 1, 2, 3, 4, and 7 (change from baseline).

Secondary outcomes

Other outcomes

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