Disease registry in Japanese adult patients with moderate-to-severe atopic dermatitis

Disease registry in Japanese adult patients with moderate-to-severe atopic dermatitis - Japan AD Registry (ADDRESS-J)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000022623

Enrollment

300

Registered

2016-06-08

Start date

2016-07-29

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

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Japanese patient who have had a diagnosis of AD according to the guideline entitled "Definition and diagnosis criteria for atopic dermatitis" (the Japanese Dermatological Association) at least 6 months before the baseline visit. 2. Investigator's Global Assessment (IGA) score of at least 3 at the baseline visits 3. Start any of the following treatments* at the baseline visit (i) Newly start AD medications (topical/oral corticosteroids or topical/oral immunosuppressant) , including changes to the higher class of topical corticosteriods (TCS)] (ii) Increase the dose of AD medication (topical/oral corticosteroids or topical/oral immunosuppressant ) which is currently being used (iii) Thorough implementation of the standard care for AD medication (topical/oral corticosteroids or topical/oral immunosuppressant ): patient education** * Ultraviolet irradiation or anti-histamine/anti-allergic drugs are excluded. ** Brief instructions on treatment usually provided on a routine outpatient basis will not be regarded as patient education.

Exclusion criteria

Exclusion criteria: 1. Treatment with an investigational drug within 8 weeks before the baseline visit 2. Presence of skin comorbidities that may interfere with study assessments

Design outcomes

Primary

Measure	Time frame
Flare (frequency, numbers, and time to first flare from baseline visit) will be determined by totaling data every 3 months and during the 2-year observation period.	—

Secondary

Measure	Time frame
Each of the following items: Every 3 months data point and at unscheduled visits -Observed value, change and percent change in IGA score -Observed value, change and percent change in EASI score -Observed value, change and percent change in Pruritus NRS (on an 11-point scale between 0 and 10) -Observed value and change in percentages of BSA involvement -Condition of nodular prurigo: (i) Present/absent (0: Absent, 1: Present) (ii) Number (1: <10, 2: >=10 and <100, 3: >=100) (iii) Maximum size of each prurigo (0: Generally <2 mm in diameter, 1: Generally >=2 mm and <4 mm in diameter, 2: Generally >=4 mm and <8 mm in diameter, 3: Generally >=8 mm) -Measured value and change in TARC levels, blood eosinophil counts, IgE levels, and LDH levels Proportion of treatment responders which are defined as below: Every 3 months data point -IGA score of 0 or 1 (on a 5-point scale) and a reduction from baseline of >=2 points -EASI-75 (>=75% reduction in EASI score from baseline) is achieved -Improvement (reduction) in Pruritus NRS of >=4 points from baseline	—

Measure

Time frame

Each of the following items: Every 3 months data point and at unscheduled visits -Observed value, change and percent change in IGA score -Observed value, change and percent change in EASI score -Observed value, change and percent change in Pruritus NRS (on an 11-point scale between 0 and 10) -Observed value and change in percentages of BSA involvement -Condition of nodular prurigo: (i) Present/absent (0: Absent, 1: Present) (ii) Number (1: <10, 2: >=10 and <100, 3: >=100) (iii) Maximum size of each prurigo (0: Generally <2 mm in diameter, 1: Generally >=2 mm and <4 mm in diameter, 2: Generally >=4 mm and <8 mm in diameter, 3: Generally >=8 mm) -Measured value and change in TARC levels, blood eosinophil counts, IgE levels, and LDH levels Proportion of treatment responders which are defined as below: Every 3 months data point -IGA score of 0 or 1 (on a 5-point scale) and a reduction from baseline of >=2 points -EASI-75 (>=75% reduction in EASI score from baseline) is achieved -Improvement (reduction) in Pruritus NRS of >=4 points from baseline

—

Countries

Japan

Contacts

Public Contactfor clinical study Public contact

Sanofi K.K. Medical Affairs

Sanofi_Medical@sanofi.com03-6301-4575

Outcome results