Helichrysum Italicum Extract in Irritant Contact Dermatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Helichrysum italicum Extract Cream, Placebo Cream.
- Who it may be relevant to
- Registry conditions: Skin Barrier Disruption and Recovery. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Croatia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Assessment of the Effect of Helichrysum Italicum Extract in Irritant Contact Dermatitis: A Randomized Controlled Clinical Trial
Overview
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
- Other Helichrysum italicum Extract Cream
Topical emollient cream containing Helichrysum italicum extract - Other Placebo Cream
A moisturizing cream without Helichrysum italicum extract applied to the designated skin site.
Primary outcome measures
- Change in Transepidermal Water Loss (TEWL) [Time frame: Baseline (prior to SLS application) and Days 1, 2, 3, 4, and 7 (change from baseline).]
- Change in Skin Hydration [Time frame: Baseline (prior to SLS application) and Days 1, 2, 3, 4, and 7 (change from baseline).]
- Change in Skin Erythema [Time frame: Baseline (prior to SLS application) and Days 1, 2, 3, 4, and 7 (change from baseline).]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Croatia · 1 center
- University of Split School of Medicine — Split
Identifiers
NCT: NCT07676253 · 2181-198-03-04-26-0036