Scientific Substantiation and Assessment of the Effectiveness of Pathogenetic Methods of Therapy … (NCT04996485) | Clinical Trial Compass
UnknownPhase 4
Scientific Substantiation and Assessment of the Effectiveness of Pathogenetic Methods of Therapy for Congenital Ichthyosis in Children
Russia50 participantsStarted 2021-03-01
Plain-language 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.
Who can participate
Age range6 Months – 18 Years
SexALL
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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
What they're measuring
1
Change in Ichthyosis Area Severity Index (IASI)
Timeframe: From Baseline up to 16 weeks
2
Change in Ichthyosis Area Severity Index (IASI)
Timeframe: 52 weeks
Trial details
NCT IDNCT04996485
SponsorNational Medical Research Center for Children's Health, Russian Federation