Testing an Intervention in Irritative Contact Dermatitis

NCT ID: NCT06189144

Last Updated: 2024-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2024-06-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Contact Dermatitis Contact Dermatitis Irritant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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experimental arm

SLS irritation model and Treatment

Group Type EXPERIMENTAL

Emollient cream treatment

Intervention Type OTHER

Rilastil Difesa Sterile cream

placebo comparator

SLS irritation model and No Treatment

Group Type PLACEBO_COMPARATOR

no treatment

Intervention Type OTHER

no treatment

Interventions

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Emollient cream treatment

Rilastil Difesa Sterile cream

Intervention Type OTHER

no treatment

no treatment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* healthy volunteers who gave written informed consent

Exclusion Criteria

* ยท 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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Split, School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Dario Leskur

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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josipa bukic

Role: STUDY_CHAIR

University of Split, School of Medicine

Locations

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School of Medicine

Split, , Croatia

Site Status RECRUITING

Countries

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Croatia

Central Contacts

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Josipa Bukic

Role: CONTACT

00385917933752

Facility Contacts

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Dario Leskur, MPharm

Role: primary

+38521557868

Darko Modun, MD, PhD

Role: backup

+38521557851

Other Identifiers

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2181-L98-03-04-23-0030

Identifier Type: -

Identifier Source: org_study_id

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