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Glycyrrhetinic Acid and Acute Irritant Dermatitis

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Jun 1, 2026 → Dec 4, 2026
See other at-risk trials from University of Split, School of Medicine

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 7 words
    • Publications: details revised at 5 of 5 entries
  2. Primary completion pushed from Jun 1, 2026 to Dec 4, 2026v5 Show 6 more changesShow less
    • Recruitment opened
    • Start date: Mar 1, 2026 to Sep 14, 2026
    • Study completion moved earlier from Apr 25, 2027 to Dec 4, 2026
    • Interventions modified
    • Trial arms changed: 8 → 10
    • Site details revised
  3. Start date: Jan 1, 2026 to Mar 1, 2026
    • Study completion date: Sep 25, 2026 to Apr 25, 2027
    v4
  4. Collaborators expanded, about 2 wordsv3
  5. Study Status, Study Description, Referencesv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07286487
Lead Sponsor University of Split, School of Medicine
Collaborators: European Union
Conditions
(from sponsor)		 Irritant Contact Dermatitis
Related terms Dermatitis, Irritant
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov