A pharmacological study of tacrolimus ointment

Phase 1

Completed

• Conditions: Atopic dermatitis

• Registration Number: JPRN-jRCT1080225219
• Lead Sponsor: Maruho Co.,Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-05
• Study Completion: 2020-08-23
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Atopic dermatitis patients

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pharmacodynamics<br>total local skin iritation

Secondary Outcome Measures

Name	Time	Method
pharmacodynamics<br>pain score, heat score, itch score<br>pharmacodynamics<br>pain NRS, heat NRS, itch NRS