Class III corticosteroid is more effective than a class I corticosteroid for treating a moderate flare-up of atopic dermatis in children.
ID
Bron
Verkorte titel
Aandoening
Atopic dermatitis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Primary outcome will be change in subjective disease severity after 24 weeks follow-up in the trial, measured with Patient-Oriented Eczema Measure (POEM) questionnaire.
Achtergrond van het onderzoek
Rationale:
Atopic dermatitis (AD) or eczema is a chronic, highly pruritic inflammatory skin disease, and is the most common chronic skin disorder in children. Eczema is in the top 10 of highest prevalence disorders in general practice in children up to 18 years
The aim of treatment is to keep the skin condition optimal, prevent flare-ups and treat symptoms as soon as they occur. Treatment is initially started by the general practitioner. According to the recently revised guideline of the Dutch College of General Practitioners (NHG) for AD, a stepwise approach is advocated; when AD is mild to moderate, a mild (class I) to moderate potent (class II) topical corticosteroid (CS) is preferred, while potent (class III) CS is used only when AD is severe. It may be that during a flare up, AD can be best treated intermittent with a potent CS (pulse treatment) in terms of time to recovery, patient satisfaction, amount of CS used, and reconsultations.
Objective:
To determine whether a potent topical corticosteroid (CS) is more effective than a mild topical CS in the treatment of children with a moderate flare-up of atopic dermatitis (AD) in primary care on short and long term.
Study design:
Prospective cohort study with an embedded open-label randomized controlled trial.
Study population:
Patients with the diagnosis AD, aged between 12 weeks and 18 years, who visited the GP for AD or received repeated prescription for AD in previous 12 months.
Intervention:
The intervention group will start with a potent CS (class III) at a flare-up of the AD.
Main study endpoints:
Changes in subjective disease severity after24 weeks follow-up in the trial, measured with a recommended and validated questionnaire for patients with AD (POEM).
Doel van het onderzoek
Class III corticosteroid is more effective than a class I corticosteroid for treating a moderate flare-up of atopic dermatis in children.
Onderzoeksopzet
Subjects will be asked to complete a weekly questionnaire (POEM) for 24 weeks.
At baseline, 1, week, 4 weeks and 24 weeks of follow-up Eczema Area and Severity Index (EASI) will be scoired.
Onderzoeksproduct en/of interventie
The intervention group will start with a potent corticosteroid (class III) when having a flare-up of the atopic dermatitis. The GP-guideline group will receive treatment according to the Dutch GP-guideline (start with mild CS class I).
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
In order to be eligible to participate in the cohort study (and possibly be
eligible for the trial), a subject must meet all of the following criteria:
- Age >12 weeks and < 18 years
- Diagnosis of eczema (ICPC-code or prescription of topical treatment of
eczema) + confirmation of the diagnosis by the GP
- 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 and <6
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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 si-e 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
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL6492 |
NTR-old | NTR6679 |
CCMO | NL61504.078.17 |
OMON | NL-OMON55693 |