Scientific Substantiation and Assessment of the Effectiveness of Pathogenetic Methods of Therapy for Congenital Ichthyosis in Children

Sponsor
National Medical Research Center for Children's Health, Russian Federation
Study ID
NCT04996485
Phase
PHASE4
Status
Unknown

Conditions

  • Congenital Ichthyosis

Eligibility Criteria

Sex
ALL
Age
6 Months - 18 Years
Healthy Volunteers
Accepted

Interventions

Study Details

This is an experimental non-randomized clinical study aimed at expanding the indications for the use of biological drugs with the aim of using them for the pathogenetic therapy of children with congenital ichthyosis.

Key Dates

Start date
Mar 1, 2021
Status verified
Jul 2021
Primary completion
Mar 1, 2023
Completion
Jun 1, 2023

Study Design

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

Arms

  • Experimental: Experimental group №1 (Secukinumab )
    Secukinumab - subcutaneous injections into the shoulder according to the schedule of 0,1,2,3 weeks, then injections 1 time in 3 months up to 52 weeks of therapy.
  • Experimental: Experimental group №2 (Ustekinumab)
    Ustekinumab - subcutaneous injections in the shoulder on schedule 0; 1 month, then every 2 months up to 52 weeks of therapy.
  • Experimental: Experimental group №3 (Dupilumab)
    Dupilumab - subcutaneous injections in the shoulder: for patients weighing from 15 to \<30 kg: initial dose - 600 mg (2 injections of 300 mg), then 300 mg every 4 weeks; for patients weighing from 30 to \<60 kg: initial dose - 400 mg (2 injections of 200 mg), then 200 mg every 2 weeks; for patients weighing 60 kg or more: the initial dose is 600 mg (2 injections of 300 mg), then 300 mg every 2 weeks.
  • Active Comparator: Control group (Symptomatic therapy)
    symptomatic therapy with emollients + systemic retinoids

Primary Outcome Measure

Change in Ichthyosis Area Severity Index (IASI) [ Time Frame: From Baseline up to 16 weeks ]

Central Contacts