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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON55693
Enrollment
360
Registered
2017-05-30
Start date
2018-02-09
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic eczema eczema

Interventions

Subjects allocated to the intervention group receive a potent CS class III once daily.

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

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

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 (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

Design outcomes

Primary

MeasureTime frame
Changes in disease severity after 24 weeks follow-up in the trial, measured with the Patient-Oriented Eczema Measure (POEM).

Secondary

MeasureTime frame
Secondary outcomes concerning trial - Changes in subjective disease severity after 1 week and 4 weeks of FU (POEM) - Changes in objective disease severity after 1 week, 4 weeks and 24 weeks of FU (EASI) - Quality of life - 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 - Quality of life - Frequency of flare-ups - Medication use - Healthcare use

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)