Atopic dermatitis
Conditions
Interventions
investigational material(s)
Generic name etc : Tacrolimus Hydrate
INN of investigational material : Tacrolimus Hydrate
Therapeutic category code : 269 Other agents for epidermis
Dosage and Administrat
Sponsors
Maruho Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Atopic dermatitis patients
Exclusion criteria
Exclusion criteria: (1) Patients with a history of, or currently with any of the following diseases: 1) malignact tumor 2) Serious allergy (shock, anaphylactoid symptoms) 3) Allergy to tacrolimus 4) Cutaneous hypersensitivity to topical drugs (e.g., allergic contact dermatitis) (2) Patients with any of the following diseases: 1) Diseases considered inappropriate for study participation, such as serious cardiac, hepatic, renal, pulmonary, or hematologic diseases 2) Severe renal dysfunction, severe hyperkalemia or symptoms caused by them 3) ulcer or erosion clearly forming a plaque at the application site of the investigational drug 4) Diseases with ichthyosis-like erythroderma (Netherton syndrome, etc.) 5) Skin infections at the application site of the investigational 6) Diseases that present with pyrexia 7) Diseases that affect the evaluation of heat sensation, pain and pruritus (except for atopic dermatitis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacodynamics total local skin iritation | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacodynamics pain score, heat score, itch score pharmacodynamics pain NRS, heat NRS, itch NRS | — |
Countries
Japan
Contacts
Public ContactClinical Trials Information -
Maruho Co.,Ltd. Kyoto R&D Center
Outcome results
None listed