Contact Dermatitis, Contact Dermatitis Irritant
Conditions
Brief 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.
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.
Interventions
OTHEREmollient cream treatment
Rilastil Difesa Sterile cream
OTHERno treatment
no treatment
Sponsors
University of Split, School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TEWL measurement with Khazaka probe | through study completion, an average of 1 year | Transepidermal water loss |
| hydration measurement with corneometer probe | through study completion, an average of 1 year | corneometer assessed stratum corneum hydration level |
| erythema measured with mexameter | through study completion, an average of 1 year | mexameter assessed redness |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical score according to dermatologist scale | through study completion, an average of 1 year | 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 |
Countries
Croatia
Contacts
Primary ContactJosipa Bukic
Outcome results
None listed