Testing an Intervention in Irritative Contact Dermatitis

Testing the Effectiveness of an Intervention in Irritative Contact Dermatitis:Randomized Controlled Trial

An eczematous reaction is an inflammatory intolerance response of the skin. In acute phase the reaction is characterized by erythema and blistering while in the chronic phase it presents as dryness, itchiness and lichenification. Irritative contact dermatitis describes these patterns of reaction in response to toxicity of chemicals on the skin cells, which trigger inflammation by activation of the innate immune system.

Study Overview

• Status: Recruiting
• Conditions: Contact Dermatitis; Contact Dermatitis Irritant
• Intervention / Treatment: Other: no treatment; Other: Emollient cream treatment

Detailed Description

An eczematous reaction is an inflammatory intolerance response of the skin. In acute phase the reaction is characterized by erythema and blistering while in the chronic phase it presents as dryness, itchiness and lichenification. Irritative contact dermatitis describes these patterns of reaction in response to toxicity of chemicals on the skin cells, which trigger inflammation by activation of the innate immune system. Therefore, the aim of this study was to see if omega cream, as proposed by its mechanism of action, could improve SLS induced contact dermatitis.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Josipa Bukic; Phone Number: 00385917933752; Email: jbukic@mefst.hr

Study Locations

• Croatia
  • Split, Croatia, 21000
    • Recruiting
    • School of Medicine
    • Contact: Dario Leskur, MPharm; Phone Number: +38521557868; Email: dario.leskur@mefst.hr
    • Contact: Darko Modun, MD, PhD; Phone Number: +38521557851; Email: darko.modun@mefst.hr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• healthy volunteers who gave written informed consent

Exclusion Criteria:

• · skin cancer

  • skin disease
  • skin damage on measurement sites
  • use of corticosteroids, antihistamines and immunomodulators a month prior the inclusion and during the trial
  • use of drugs that may cause photosensitivity
  • use of emollients three days prior the inclusion in the trial
  • non-adherence to the trial protocol
  • exposure to artificial and excessive natural ultraviolet (UV) radiation
  • pregnancy and lactation
  • history of vitiligo, melasma and other pigmentation and photosensitivity disorders
  • immunosuppression
  • allergic or irritant reactions to the constituents of the cream

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental arm; SLS irritation model and Treatment	Other: Emollient cream treatment; Rilastil Difesa Sterile cream
Placebo Comparator: placebo comparator; SLS irritation model and No Treatment	Other: no treatment; no treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TEWL measurement with Khazaka probe	Transepidermal water loss	through study completion, an average of 1 year
hydration measurement with corneometer probe	corneometer assessed stratum corneum hydration level	through study completion, an average of 1 year
erythema measured with mexameter	mexameter assessed redness	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical score according to dermatologist scale	Skin response to irritation and treatment will be assessed using a five-point scale to describe changes in skin erythema, roughness, scaling, oedema, and fissure	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: University of Split, School of Medicine
• Investigators: Study Chair: josipa bukic, University of Split, School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: September 13, 2023
• First Submitted That Met QC Criteria: December 18, 2023
• First Posted (Actual): January 3, 2024

Study Record Updates

• Last Update Posted (Actual): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Eczematous; Dermatitis; Dermatitis, Contact; Dermatitis, Irritant; Dermatologic Agents; Emollients
• Other Study ID Numbers: 2181-L98-03-04-23-0030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: On request
• IPD Sharing Time Frame: On request
• IPD Sharing Access Criteria: On request
• IPD Sharing Supporting Information Type: ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No