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

Sponsor
National Medical Research Center for Children's Health, Russian Federation
Study ID
NCT04895423
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Methotrexate therapy — DRUG
    Methotrexate subcutaneously 10-15 mg/m2 once every 7 days within 12 months
  • Mycophenolate mofetil therapy — DRUG
    Mycophenolate mofetil per os 500-700 mg/m2 2 times a day within 12 months
  • Cyclosporine therapy — DRUG
    Cyclosporine per os 3 mg/m2 2 times a day within 12 months
  • Dupilumab therapy — DRUG
    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.

Study Details

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.

Key Dates

Start date
Nov 25, 2021
Status verified
May 2021
Primary completion
Jul 25, 2023
Completion
Jul 25, 2023

Study Design

Enrollment
160 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group №1: Methotrexate therapy
  • Experimental: Group №2: Mycophenolate mofetil therapy
  • Experimental: Group №3: Cyclosporine therapy
  • Experimental: Group №4: Dupilumab therapy

Primary Outcome Measure

SCORAD (Scoring of Atopic Dermatitis) [ Time Frame: screening (baseline), 3, 4, 6 and 12 months from the start of therapy ]

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