WAL 801 CL Dry Syrup in Paediatric Atopic Dermatitis Patients

Inclusion Criteria: For inclusion in this study, patients must be pediatric atopic dermatitis patients thatmeet the following criteria and thus be appropriate for observation of pruritus. Diagnosisof atopic dermatitis was 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

• One week or longer has passed since the patient started to use an external steroidpreparation at "Strong" or lower grade, or stopped using any external steroidpreparation, at the time of obtainment of consent from the patient

• Pruritus with "2" or higher grade, immediately before initial administration

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 "Very Strong" or higher grade in any sitesother than the face or scalp within 2 weeks before initial administration of theinvestigational product

• 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

• Present and past history of convulsive disorder, such as epilepsy (convulsionthreshold values may be lowered by the reference drug, Ketotifen Fumarate)

• Clinically significant hepatic, renal, or cardiac disease or other complications:therefore, judgement that the patient is ineligible for inclusion in this study (Please note that patients must be excluded from the study if the patients fell underGrade 2 or more, in the MHW (Ministry of health and welfare) Adverse Reaction SeverityClassification Criteria.)

• 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