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

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Medical Research Center for Children's Health, Russian Federation
• Treatments: Ustekinumab

Criteria

Inclusion Criteria:

• The subject has signed an informed consent; parental or legal representative consent for patients under 18 years of age, as well as additional consent for patients aged ≥ 15 and <18.

• At the time of participation in the study, the age of the subject is not less than 6 months and not more than 18 years.

• At the time of participation in the study, a clinical diagnosis was established:

Congenital ichthyosis with various clinical forms, with the exception of vulgar and X - linked congenital ichthyosis (genetic research is not a prerequisite for participation in the study).

• Subjects should have at least moderate IASI erythema associated with his / her ichthyosis, and a decrease in the quality of life according to CDLQI ≥ 10

• Absence of signs of severe infectious diseases (pneumonia, tuberculosis, etc.)

• No previous history of the use of the following genetically engineered biological drugs: ustekinumab, secukinumab, dupilumab

Exclusion Criteria:

• Subjects who have an allergic reaction to ustekinumab, secukinumab or other components of the drugs.

• Subjects who have bacterial and/or fungal diseases.

• Subjects who have problems in dynamic observation.

• Subjects who will have a worsening of clinical symptoms