Atopic dermatitis
Conditions
Interventions
Trade Name: Hydrocortison crème 10 mg/g FNA Fagron
Product Name: Hydrocortison crème 10 mg/g FNA Fagron
Product Code: RVG 20729
Pharmaceutical Form: Cream
Trade Name: Hydrocortison-vaselinecrème DMB
Sponsors
Erasmus MC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in the cohort study (and possibly be elegible for the trial),a subject must meet all of the following criteria: - Age >12 weeks =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A potential patient who meets any of the following criteria will be excluded from participation in the cohort study: - As determined by the GP (e.g. family problems) - Currently under treatment of a dermatologist - Language barrier - No access to internet (necessary to fill in weekly online questionnaire) - Contra-indications for the study medication: ? previously side effects with any of the medications ? hypersensitivity to corticosteroids A potential patient who meets any of the following criteria will be excluded from participation in the trial: - Use of CS in 2 weeks before inclusion in trial - >50% of body affected - Other skin disorders hampering proper assessment of eczema - Pregnancy and or breastfeeding - Contra-indications for the study medication: ? untreated skin infections caused by a bacterium, virus, fungal, or parasite ? incurable wounds, ulcerative skin disorders ? ichthyoses, acne vulgaris, rosacea, juvenile plantar dermatosis, skin atrophy, skin lesions ? diaper rash ? perianal and genital itching A potential subject who meets any of the following criteria will be excluded from participation in the trial: - Use of CS in 2 weeks before inclusion in trial - >50% of body affected - Other skin disorders hampering proper assessment of eczema - Pregnancy and or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective: To determine whether a potent topical CS is more effective than a mild topical CS in the treatment of children with a moderate flare-up of atopic dermatitis in primary care on short and long term. ;Secondary Objective: Secondary outcomes concerning trial - Changes in disease severity after 4 weeks - Quality of life with the IDQOL or CDLQI depending on age - Compliance - Local side-effects - Systemic side-effects - Time to recovery - Frequency of flare-ups - Medication use - Healthcare use Secondary outcomes concerning cohort: - Severity of disease using POEM and EASI - Quality of life with the IDQOL or CDLQI depending on age - Frequency of flare-ups - Medication use - Healthcare use ;Primary end point(s): Changes in disease severity after 1 and 24 weeks follow-up in the trial, measured with the Patient-Oriented Eczema Measure (POEM) and the Eczema Area and Severity Index (EASI).;Timepoint(s) of evaluation of this end point: 1 week follow-up 24 weeks of follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcomes concerning trial - Changes in disease severity after 4 weeks - Quality of life with the IDQOL or CDLQI depending on age - Compliance - Local side-effects - Systemic side-effects - Time to recovery - Frequency of flare-ups - Medication use - Healthcare use - Healthcare use;Timepoint(s) of evaluation of this end point: 1 week follow-up 4 weeks of follow-up 24 weeks of follow-up | — |
Countries
Netherlands
Contacts
Public ContactDepartment of General Practice
Erasmus MC
Outcome results
None listed