Testing an Intervention in Irritative Contact Dermatitis

Contact Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06189144
• Other study ID #: 2181-L98-03-04-23-0030
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: December 2023
• Source: University of Split, School of Medicine
• Contact: Josipa Bukic
• Phone: 00385917933752
• Email: jbukic[@]mefst.hr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Contact Dermatitis
• Dermatitis
• Dermatitis, Contact

Intervention

Other:
• Emollient cream treatment
Rilastil Difesa Sterile cream
• no treatment
no treatment

Locations

Country	Name	City	State
Croatia	School of Medicine	Split

Sponsors (1)

Lead Sponsor	Collaborator
University of Split, School of Medicine

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TEWL measurement with Khazaka probe	Transepidermal water loss	through study completion, an average of 1 year
Primary	hydration measurement with corneometer probe	corneometer assessed stratum corneum hydration level	through study completion, an average of 1 year
Primary	erythema measured with mexameter	mexameter assessed redness	through study completion, an average of 1 year
Secondary	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