Efficacy of Duplimab in axon-reflex-mediated sweating disorder in atopic dermatitis

JRCT ID: jRCT1071200016

Registered date:08/06/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: atopic dermatitis
• Date of first enrollment: 01/07/2020
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Intervention with dupilumab for moderate or higher atopic dermatitis

Outcome(s)

• Primary Outcome: Change of sweat volume and latency time in QSART before and after administration of dupilumab

Secondary Outcome

Changes in the following items before and after treatment
1)Skin symptoms (EASI score, rosacea clinical score)
2)Serum TARC value
3)Itching (Visual analog scale)
4)QOL (Patient oriented eczema measure: POEM)
5)Skin flora
6)State-trait anxiety inventory: STAI

Key inclusion & exclusion criteria

• Age minimum: >= 15age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) never administration of dupilumab
2) atopic dermatitis patients who are poor control for existing treatment (EASI score:16 or more and IGA score: 3 or more and Body surface area: 10% or more)
3) age: 15 years or older
4) Patients (or subtitle in case the patient is minor) who got sufficient informed and consent in writing

Exclude criteria

1) Contraindications to dupilumab (hypersensitivity, nursing women)
2) Contraindications to obisort(Bronchial asthma, Hyperthyroidism, Severe heart disease, Gastrointestinal ulcer, allergy to obisort, Addison's disease, Gastrointestinal tract or bladder neck obstruction, Epilepsy, parkinsonism, pregnant or may be pregnant women)
3) Patients who are receiving UV therapy, oral cyclosporine, systemic steroid therapy, or need to continue these therapy
4) serious allergy to tape or coating material
5) In addition, patients judged by the investigator to be inappropriate as study subjects

Related Information

• Primary Sponsor: MATSUMOTO MAI