Phase
Condition
Dermatitis, Atopic
Allergy
Eczema (Atopic Dermatitis - Pediatric)
Treatment
N/AClinical Study ID
Ages < 15 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: For inclusion in this study, subjects must be pediatric atopic dermatitis patients thatmeet the following criteria and thus be appropriate for observation of pruritus. Diagnosisof atopic dermatitis will be conducted in accordance with the "Definition and DiagnosticCriteria of Atopic Dermatitis", issued by the Japanese Dermatological Association.
15 years of age or younger
Body weight of 14 kg or more
Outpatients
The patient has been undergoing treatment with a "very strong" or lower-grade externalsteroid preparation for >= 1 week at the time informed consent is obtained
Pruritus with "2" or higher grade at the start time of administration
Exclusion
Exclusion Criteria:
Use of sustained release adrenocorticotropic hormone (Kenacort® A, Depo-medrol®,etc.), oral preparation of methotrexate, or oral preparation of ciclosporin, within 4weeks before initial administration of the investigational product
Oral intake, inhalation and injection of any steroid within 2 weeks before initialadministration of the investigational product
Use of any external steroid preparation at "Strongest" in any sites other than theface or scalp within 2 weeks before initial administration of the investigationalproduct
Undergoing phototherapy
Undergoing specific desensitization therapy or modulation therapy
Past history of contact dermatitis caused by external steroid preparation
Possibility of exacerbation by an external steroid preparation of infectious skindisease caused by bacteria, fungi, or virus
Clinically significant hepatic, renal, or cardiac disease or other complications:therefore, judgement that the patient was ineligible for inclusion in this study.Patients must be excluded from the study if the patients fell under Grade 2 or more,in the MHW (Ministry of health and welfare) Adverse Reaction Severity ClassificationCriteria
Past history of allergy to any drug
Participation in any other clinical study, or history of participation in any otherclinical study within 6 months before the date when the patient gave consent toparticipate in this study
Judgement by the Principal Investigator or Investigator that the patient is ineligiblefor inclusion in this study