A randomized, open-label, parallel group study to evaluate the efficacy and safety of proactive management in pediatric subjects with moderate to severe atopic dermatitis

A randomized, open-label, parallel group study to evaluate the efficacy and safety of proactive management in pediatric subjects with moderate to severe atopic dermatitis - Efficacy and safety of proactive management in childhood atopic dermatitis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005536

Enrollment

Registered

2011-05-02

Start date

2011-05-01

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

A proactive approach by using topical corticosteroids (i.e. twice-a-week) to all previously identified affected areas with confirmation of no exacerbation. At exacerbation, patients apply topical cor

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Eligible patients are boys and girls aged 3 months to 15 years with a diagnosis of atopic dermatitis according to the criteria of Hanifin and Rajka. The patients had moderate to severe AD as defined by the scoring system of Rajka and Langeland.

Exclusion criteria

Exclusion criteria: The exclusion criteria is as followed; (1) The patients receiving any additional systemic therapies included corticosteroids, nonsteroidal immunosuppressive agents or biological immunotherapy, (2) the patients who has a past history of cardiovascular disease, liver dysfunction, kidney disease and other current serious medical problems.

Design outcomes

Primary

Measure	Time frame
Proportion of patients with SCORAD < 20 and SCORAD <50 at each study visit [Time Frame: 24 months]	—

Secondary

Measure	Time frame
Decrease of total serum IgE after 3, 6, 12 and 24 months of treatment [Time Frame: at 3, 6, 12 and 24 months] Change of immunological parameters (blood eosinophil count, TARC, specific IgE, IL-4, IL-5, IL-13, IL-17, IL-33, IFN-gamma) [Time Frame: at 3, 6, 12 and 24 months] Quality of life (Children's dermatology life quality index and the dermatitis family impact questionnaire) at 6, 12 and 24 months. Intensity of pruritus at each day as reported in the patient's diary by means of visual analogue scale (VAS) Change of serum and salivary cortisol level at 6, 12 and 24 months [Time Frame: at 6, 12 and 24 months] Local side effects on the skin, and incidence and severity of adverse event at each study visit [Time Frame: 24 months]	—

Measure

Time frame

Decrease of total serum IgE after 3, 6, 12 and 24 months of treatment [Time Frame: at 3, 6, 12 and 24 months] Change of immunological parameters (blood eosinophil count, TARC, specific IgE, IL-4, IL-5, IL-13, IL-17, IL-33, IFN-gamma) [Time Frame: at 3, 6, 12 and 24 months] Quality of life (Children's dermatology life quality index and the dermatitis family impact questionnaire) at 6, 12 and 24 months. Intensity of pruritus at each day as reported in the patient's diary by means of visual analogue scale (VAS) Change of serum and salivary cortisol level at 6, 12 and 24 months [Time Frame: at 6, 12 and 24 months] Local side effects on the skin, and incidence and severity of adverse event at each study visit [Time Frame: 24 months]

—

Countries

Japan

Contacts

Public ContactTatsuki Fukuie

Hamamatsu University School of Medicine Department of Pediatrics

fukuie-t@hama-med.ac.jp053-435-2312

Outcome results

None listed

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