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Randomized controlled trial to evaluate clinical efficacy of once- or twice-daily skincare with emollient for prevention of atopic dermatitis exacerbation

Randomized controlled trial to evaluate clinical efficacy of once- or twice-daily skincare with emollient for prevention of atopic dermatitis exacerbation - Randomized controlled trial of once- or twice-daily skincare for atopic dermatitis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000005158
Enrollment
150
Registered
2011-03-07
Start date
2011-03-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Atopic dermatitis

Interventions

Once- daily skincare during 4 to 6 weeks Twice-daily skincare During 4 to 6 weeks

Sponsors

National Center for Child Health and Development
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients who are diagnosed as having atopic dermatitis based on the diagnostic criteria of Hanifin & Rajka 2) Patients who were diagnosed as having moderate or severe atopic dermatitis within a year 3) Patients whose skin condition should be maintained without skin eczema by using twice weekly betamethasone valerate ointment and twice daily emollient at the time of enrollment 4) Patients who can adhere twice-daily skincare treatment.

Exclusion criteria

Exclusion criteria: Patients who are taking oral steroids and/or oral immunosuppressive drug

Design outcomes

Primary

MeasureTime frame
1. The rates of patients with free of recurrence during 28 days of intervention. 2. No symptom days after entry of this intervention.

Secondary

MeasureTime frame
1. QOL of a caregiver (a parent) 2. Scoring atopic dermatitis (SCORAD) 3. Incidence of skin infection

Countries

Japan

Contacts

Public ContactYukihiro Ohya

National Center for Child Health and Development Division of Allergy

03-3416-0181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026