Effectiveness of different strengths of topical steroids: providing evidence for a better treatment strategy in children with atopic dermatitis in general practice.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 360

Inclusion Criteria

In order to be eligible to participate in the cohort study,a subject must meet
all of the following criteria:
- Age >12 weeks <18 years
- Diagnosis of eczema (ICPC-code or prescription of topical treatment of
eczema) + confirmation of the diagnosis by the GP or diagnosis of eczema as
estated by the parents (only for open recruitment of the cohort)
- Consultation or repeated prescription in previous 12 months
- Informed consent, In order to be eligible to participate in the trial, a
subject must meet all of the following criteria:
- Participation in cohort (see above)
- Flare-up (i.e. need to intensify topical treatment) from patients and/or
parents point of view
- TIS-score *3 *6

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 (this is not an exclusion
criterion for open recruitment of the cohort)
- 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
- AD on eyelid(s).
- 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Changes in disease severity after 24 weeks follow-up in the trial, measured<br /><br>with the Patient-Oriented Eczema Measure (POEM).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes concerning trial<br /><br>- Changes in subjective disease severity after 1 week and 4 weeks of FU (POEM)<br /><br>- Changes in objective disease severity after 1 week, 4 weeks and 24 weeks of<br /><br>FU (EASI)<br /><br>- Quality of life<br /><br>- Compliance<br /><br>- Local side-effects<br /><br>- Systemic side-effects<br /><br>- Time to recovery<br /><br>- Frequency of flare-ups<br /><br>- Medication use<br /><br>- Healthcare use<br /><br><br /><br>Secondary outcomes concerning cohort:<br /><br>- Severity of disease<br /><br>- Quality of life<br /><br>- Frequency of flare-ups<br /><br>- Medication use<br /><br>- Healthcare use</p><br>