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Baricitinib for Prurigo nodularis: A pilot study on efficacy and safety

Phase 2
Completed
Conditions
Prurigo nodularis
Baricitinib
Registration Number
TCTR20230227002
Lead Sponsor
Thammasat university hospital
Brief Summary

This pilot investigation underscores the potential of baricitinib in Prurigo nodularis treatment, offering rapid clinical responses. However, larger and longer randomized controlled trials are needed to ascertain the efficacy, durability, and safety of baricitinib in Prurigo nodularis treatment.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
12
Inclusion Criteria

moderate to severe prurigo nodularis (>= 20 nodules) persist 6 months or more

Exclusion Criteria

1.Chronic pruritus not from Prurigo nodularis
2.Have latent or active Tuberculosis, HBV infection, HCV infection, HIV infection
3.Have history of Myocardial infarction, Unstable ischemic heart disease
4.Have history of Heart failure within 12 weeks before enrollment
5.Have history of Stroke
6.Have history of Deep vein thrombosis or pulmonary thromboembolism
7.Have history of uncontrolled disease eg. uncontrolled infection, active cancer
8.Currently on systemic immunosuppressants within 4 weeks before enrollment
9.hemoglobin less than 10.0 g/dL, total white blood cell less than 2500 cells/uL, neutropenia less than 1200 cells/uL, lymphopenia less than 750 cells/uL, thrombocytopenia less than 100000 cells/uL
10.Prenant woman or planned pregnant

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
itchy scale, number of lesions 12 weeks picture, Investigator global assessment , Prurigo nodularis severity , pruritus numerical rating scale, Dermatology Life Quality Index
Secondary Outcome Measures
NameTimeMethod
safety 12 weeks blood test, inquiry
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