An interventional study of Helichrysum italicum Extract Cream and Placebo Cream in Skin Barrier Disruption and Recovery, sponsored by University of Split, School of Medicine. Recruiting at 1 site in Croatia. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by University of Split, School of Medicine · Not applicable, Interventional, and Treatment
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:
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:
University of Split, School of Medicine is the lead sponsor of 51 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a topical emollient cream containing Helichrysum italicum extract applied to an SLS-treated skin site.
Other: Helichrysum italicum Extract Cream
Participants will receive the same emollient cream base without Helichrysum italicum extract applied to an SLS-treated skin site.
Other: Placebo Cream
An SLS-treated skin site that will not receive any topical treatment and will serve as a control for natural skin barrier recovery.
Topical emollient cream containing Helichrysum italicum extract
A moisturizing cream without Helichrysum italicum extract applied to the designated skin site.
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).
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).
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).
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Jan 2027, 7 months after the start.
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Dermatitis, Irritant
University of Split, School of Medicine