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Evaluation of the Effectiveness and Safety of Immunosuppressive and Biological Therapy of Atopic Dermatitis in Childhood

NCT04895423 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2021-05-20

No results posted yet for this study

Summary

This comparative study analyzes the efficacy and safety of treatment of children from 6 years of age suffering from moderate to severe atopic dermatitis using an inhibitor of IL4, IL13 and classical immunosuppressants.

Conditions

Interventions

DRUG

Methotrexate therapy

Methotrexate subcutaneously 10-15 mg/m2 once every 7 days within 12 months

DRUG

Mycophenolate mofetil therapy

Mycophenolate mofetil per os 500-700 mg/m2 2 times a day within 12 months

DRUG

Cyclosporine therapy

Cyclosporine per os 3 mg/m2 2 times a day within 12 months

DRUG

Dupilumab therapy

Patients weighing \<30 kg received an initial dose of 600 mg (2 injections of 300 mg subcutaneously), then 300 mg every 4 weeks. Patients weighing 30 to \<60 kg received an initial dose of 400 mg (2 injections of 200 mg subcutaneously), then 200 mg every 2 weeks; Patients weighing 60 kg or more, the initial dose is 600 mg (2 injections of 300 mg subcutaneously), then 300 mg every 2 weeks.

Sponsors & Collaborators

  • National Medical Research Center for Children's Health, Russian Federation

    lead OTHER_GOV

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-25
Primary Completion
2023-07-25
Completion
2023-07-25

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04895423 on ClinicalTrials.gov