Dry skin barrier disorders such as atopic eczema and ichtyosis
Conditions
Interventions
Product Name: Calmuril Fat Cream
Pharmaceutical Form: Cream
CAS Number: 57136
Other descriptive name: UREA
Concentration unit: % percent
Concentration type: equal
Concentration number: 10-
Other descr
Sponsors
ACO HUD NORDIC AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Dry skin barrier disorders such as atopic dermatitis (Patientgroup 1) • Malassezia eradicated head and neck dermatitis (Patientgroup 2) • Rough or clinically normal skin on the volar aspect of the forearm • Either gender • Age between 18 and 65 years • Written Informed Consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Possible allergy to ingredients in the study medications • Use of any concomitant medication that may interfere with the study related activities or assessment of efficacy • Any patient related factor suggesting potential poor compliance with study procedures (e.g. psychiatric disorders, history of alcohol or substance abuse) • Any serious medical condition which, in the opinion of the investigator, may interfere with the evaluation of the results • Pregnancy or breast feeding, or patients who plan to become pregnant during the course of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To compare the effect from a new active emulsion and its placebo on skin barrier function ;Secondary Objective: • To compare the effect from a new active emulsion and a reference cream on skin barrier function for Malassezia patients • To compare the influence of new active treatment with placebo and new active treatment with reference on Malassezia recurrence • To study the degree of adverse skin reactions (stinging) • To study the willingness to pay for a treatment not inducing stinging at application. • To study the skin hydrating effect of the creams • To evaluate cosmetic variables of the creams ;Primary end point(s): • skin susceptibility to irritation from an irritating agent measured as transepidermal water loss (TEWL) after treatment with new active emulsion and its placebo The skin barrier function measured as TEWL prior to application of irritating agent is supportive to the primary variable | — |
Countries
Sweden
Outcome results
None listed