About this trial
Irritant dermatitis is one of the most common inflammatory skin disorders, caused by exposure to external substances that induce inflammation and immune activation. Standard management includes avoidance of irritants, restoration of the skin barrier using emollients, and the application of anti-inflammatory drugs such as topical corticosteroids. However, due to the risks associated with long-term corticosteroid use, there is an interest in developing emollient formulations enriched with bioactive compounds possessing anti-inflammatory properties. Among those promising compounds is glycyrrhetinic acid.
18β-Glycyrrhetinic acid, a bioactive component of licorice root extract, exhibits potent anti-inflammatory and antioxidant effects. Topical application has demonstrated beneficial outcomes in conditions such as atopic dermatitis, acne, pruritus, and UVB-induced skin damage. Its proposed mechanisms of action include inhibition of key inflammatory enzymes (COX, 5-LOX, iNOS) and promotion of skin regeneration through stimulation of aquaporin-3 expression and enhancement of epidermal turnover.
Topical application of formulations containing 18β-glycyrrhetinic acid will improve skin parameter disturbances caused by irritation induced with sodium lauryl sulfate.
This study aims to evaluate the effects of 18β-glycyrrhetinic acid on human skin parameters in an acute irritant dermatitis model induced by sodium lauryl sulfate, providing further insight into its potential role as an anti-inflammatory and barrier-restoring agent.
Funding:
Funded by the European Union - NextGenerationEU. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or the European Commission. Neither the European Union nor the European Commission can be held responsible for them.
Eligibility criteria
Qualifiers
Healthy adult participants aged 18 years or older, of any sex.
Intact, healthy skin at the test sites.
No use of systemic or topical corticosteroids, immunomodulators, or antihistamines within the previous three months.
No use of topical emollients on the test sites within the previous seven days.
Disqualifiers
Pregnant women, women suspected of being pregnant, and breastfeeding women.
Non-compliance with the study protocol.
Voluntary withdrawal or personal decision not to continue participation.
Trial design
Treatments tested in this trial
- SLS induced irritation
- No Treatment
- Placebo
- Lower Dose Glycyrrhetinic Acid
- Higher Dose Glycyrrhetinic Acid
Treatment groups
8
Treatment groupsSee each treatment group below.
Sponsors and collaborators
University of Split, School of Medicine
Lead sponsor
European Union
Collaborator