NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT1071200016

Registered date:08/06/2020

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

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedatopic dermatitis
Date of first enrollment01/07/2020
Target sample size10
Countries of recruitment
Study typeInterventional
Intervention(s)Intervention with dupilumab for moderate or higher atopic dermatitis

Outcome(s)

Primary OutcomeChange of sweat volume and latency time in QSART before and after administration of dupilumab
Secondary OutcomeChanges 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 maximumNot applicable
GenderBoth
Include criteria1) 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 criteria1) 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

Contact

Public contact
Name Mai Matsumoto
Address 1-7-1 Sakamto-machi Nagasaki-shi Nagasaki-Ken Nagasaki Japan 852-8102
Telephone +81-95-819-7333
E-mail m.honda@nagasaki-u.ac.jp
Affiliation Nagasaki University Hospital
Scientific contact
Name MAI MATSUMOTO
Address 1-7-1 Sakamto-machi Nagasaki-shi Nagasaki-Ken Nagasaki Japan 8528102
Telephone +81-95-819-7333
E-mail m.honda@nagasaki-u.ac.jp
Affiliation Nagasaki University Hospital