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A PhaseII Study of JTE-052 Ointment in Pediatric Patients with Atopic Dermatitis

A PhaseII Study of JTE-052 Ointment in Pediatric Patients with Atopic Dermatitis

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080223498
Enrollment
90
Registered
2017-03-31
Start date
2017-05-08
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

Sponsors

Japan Tobacco Inc.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with atopic dermatitis Modified Eczema Area and Severity Index(mEASI) >=5

Exclusion criteria

Exclusion criteria: Patients with active infection Patients with history of tuberculosis Patients with hepatitis B/C virus carriers or history of hepatitis B/C virus infection Patients with history or presence of malignant tumor Use of topical corticosteroids (strongest or very strong) within 28 days before baseline Use of topical corticosteroids (strong, medium or weak) or tacrolimus hydrate ointment within 7 days before baseline

Design outcomes

Primary

MeasureTime frame
efficacy Percent change in mEASI

Secondary

MeasureTime frame
efficacy Eczema Area and Severity Index (EASI) Investigator's Global Assessment (IGA) Face and neck IGA Assessment of the target lesion (severity score and IGA) Pruritus score (assessed by the subjects or their legal representatives) Itching severity score (assessed by the investigator) Percent body surface area (%BSA) affected by eczema with inflammation Time (in days) to worsening of the target disease

Countries

Japan

Outcome results

None listed

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