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Assessment of the Effect of Helichrysum Italicum Extract in Irritant Contact Dermatitis: A Randomized Controlled Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
View:

• healthy volunteers who gave written informed consent

Locations
Other Locations
Croatia
University of Split School of Medicine
RECRUITING
Split
Contact Information
Primary
Josipa Bukić
jbukic@mefst.hr
+385917933753
Time Frame
Start Date: 2026-06-01
Estimated Completion Date: 2027-01
Participants
Target number of participants: 30
Treatments
Experimental: Helichrysum italicum Extract Cream
Participants will receive a topical emollient cream containing Helichrysum italicum extract applied to an SLS-treated skin site.
Placebo_comparator: Placebo Cream
Participants will receive the same emollient cream base without Helichrysum italicum extract applied to an SLS-treated skin site.
No_intervention: Untreated Control Site
An SLS-treated skin site that will not receive any topical treatment and will serve as a control for natural skin barrier recovery.
Related Therapeutic Areas
Sponsors
Leads: University of Split, School of Medicine

This content was sourced from clinicaltrials.gov