Testing an Intervention in Irritative Contact Dermatitis

University of Split

Status: Enrolling

Conditions: Contact Dermatitis; Contact Dermatitis Irritant

Treatments: Other: Emollient cream treatment; Other: no treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06189144

2181-L98-03-04-23-0030

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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25 participants in 2 patient groups, including a placebo group

experimental arm

Experimental group

Description:

SLS irritation model and Treatment

Treatment:

Other: Emollient cream treatment

placebo comparator

Placebo Comparator group

Description:

SLS irritation model and No Treatment

Treatment:

Other: no treatment