Atopic Dermatitis MedDRA version: 17.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Protopic 0.03% ointment
Pharmaceutical Form: Ointment
INN or Proposed INN: TACROLIMUS
CAS Number: 104987-11-3
Concentration unit: % percent
Concentration type: equal
Concentration number:
Sponsors
Astellas Pharma China, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria for period 1: Diagnosed as AD according to Williams diagnostic criteria, and moderate or severe atopic dermatitis according to the criteria of Rajka and Langeland Patients of 2-15 years old, male or female; Patient is able to reach the centre within 3 days in case of a disease exacerbation. A signed informed consent by the patient’s legal representative, if the patient has ability to understand the purpose and risk of the study then a written consent by the patient will also be needed. Inclusion Criteria for period 2: Patients who have completed the Period 1 of the study; and Patients with IGA =2 at the end of Period 1 of the study. Are the trial subjects under 18? yes Number of subjects for this age range: 120 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients with known allergy to tacrolimus ointment; Patients with serious skin infections in AD skin lesions area; Patients with serious liver and kidney disease, blood system disease, autoimmune disease, chronic severe infections, diabetes, mental illness, and abusing illegal drugs and alcohol sufficient; Patients with malignant tumor or other serious disease which may affect the correct evaluation of efficacy; Patients using local corticosteroids or other immunosuppressive drugs within 1 week, or withdraw time of systematic corticosteroids and other immunosuppressive drugs(cyclosporine, leigongteng, etc.) within 4 weeks; Patients who participated previously in another clinical study within 1 month; and Patients with other reasons for which the investigators consider they should not be enrolled.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess if proactive, 2 times-weekly application of 0.03% tacrolimus ointment can extend remission time to relapse and reduce the incidence of disease exacerbation (DE) in paediatric patients over a period of 6 months.;Secondary Objective: Not applicable;Primary end point(s): Time of first relapse ;Timepoint(s) of evaluation of this end point: From the end of Period 1 to the first relapse. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number of relapse during Period 2; Severity of AD when recurs in Period 2 (EASI and IGA); Duration of relapse in Period 2; Pruritus score (VAS) when relapse in Period 2; Amount of usage of Tacrolimus in Period 2; and Overall effective rate (EASI) in Period 1. ;Timepoint(s) of evaluation of this end point: Period 2; and Period 1 and 2 for EASI | — |
Countries
China
Contacts
Public ContactService Desk
Astellas Pharma Europe B.V.
Outcome results
None listed