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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Helichrysum italicum Extract Cream
Other interventionTopical emollient cream containing Helichrysum italicum extract
Placebo Cream
Other interventionA moisturizing cream without Helichrysum italicum extract applied to the designated skin site.
Treatment groups
Trial outcomes
Primary outcomes
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
Change in Skin Hydration
Hydration of the stratum corneum will be assessed using a Corneometer CM 825 probe.
Change in Skin Erythema
Skin erythema will be assessed using a Mexameter MX 18 probe.
Sponsors and contacts
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