Skin Barrier Disruption and Recovery
Conditions
Keywords
Helichrysum italicum, Immortelle, Irritant contact dermatitis, Skin barrier recovery
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.
Interventions
OTHERHelichrysum italicum Extract Cream
Topical emollient cream containing Helichrysum italicum extract
OTHERPlacebo Cream
A moisturizing cream without Helichrysum italicum extract applied to the designated skin site.
Sponsors
University of Split, School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Transepidermal Water Loss (TEWL) | 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 |
| Change in Skin Hydration | 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. |
| Change in Skin Erythema | 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. |
Countries
Croatia
Contacts
CONTACTJosipa Bukić
Outcome results
None listed