A Phase 4 interventional study of Methotrexate therapy and Mycophenolate mofetil therapy in Atopic Dermatitis, sponsored by National Medical Research Center for Children's Health, Russian Federation. Status unknown at 1 site in Russian Federation. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2021-05-20.
Sponsored by National Medical Research Center for Children's Health, Russian Federation · Phase 4, Interventional, and Treatment
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.
This is a prospective study aimed at direct comparative analysis of the efficacy and safety of treatment of children from 6 years of age suffering from moderate and severe atopic dermatitis using a genetically engineered biological drug and classical immunosuppressants.
Based on clinical and anamnestic data, compliance with the inclusion / exclusion criteria, the study included 160 patients from 6 years old, with moderate / severe atopic dermatitis.
The initial indices were assessed: SCORAD- Scoring of Atopic Dermatitis (index for assessing the severity of atopic dermatitis); NRS- numeric rating scale for itch; CDLQI - The Children's Dermatology Life Quality Index; POEM- Patient-Oriented Eczema Measure (personalized assessment of eczema) and laboratory parameters: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, lactate dehydrogenase, gamma-glutamyltransferase, total bilirubin, direct bilirubin, serum albumin, blood urea specific IgE to food and household allergens, indicators of a clinical blood test, indicators of a general analysis of urine, indicators of a biochemical analysis of urine (creatinine, urea).
In the presence of concomitant allergic pathology (bronchial asthma, allergic rhinitis), the CSMS [Combined Symptom and Medication Score] were additionally assessed (Scale for assessing nasal symptoms of rhinitis, taking into account the need for medication); VAS - Visual Analog Scale (visual analog scale); ACT- Asthma Control Test. Subsequently, systemic therapy was prescribed: metorexat (40 people), mycophenolate mofetil (40 people), cyclosporine (40 people) dupilumab (40 people).
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's planned enrollment of 160 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →National Medical Research Center for Children's Health, Russian Federation is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Consent to discontinue the use of the following prohibited drugs or any of the following therapies at least 4 weeks before the start of the study and not to use them throughout the study, unless otherwise specified below:
Exclusion Criteria:
Therapy with the following drugs:
Drug: Methotrexate therapy
Drug: Mycophenolate mofetil therapy
Drug: Cyclosporine therapy
Drug: Dupilumab therapy
Methotrexate subcutaneously 10-15 mg/m2 once every 7 days within 12 months
Mycophenolate mofetil per os 500-700 mg/m2 2 times a day within 12 months
Cyclosporine per os 3 mg/m2 2 times a day within 12 months
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.
SCORAD (Scoring of Atopic Dermatitis)
change of the SCORAD index
Time frame: screening (baseline), 3, 4, 6 and 12 months from the start of therapy
NRS (Numeric rating scale for itch)
change of the NRS
Time frame: screening (baseline), 3, 4, 6 and 12 months from the start of therapy
Adverse events
Adverse events monitoring
Time frame: screening (baseline), 3, 4, 6 and 12 months from the start of therapy
CDLQI (The Children's Dermatology Life Quality Index)
change of the CDLQI
Time frame: screening (baseline), 3, 4, 6 and 12 months from the start of therapy
POEM (Patient-Oriented Eczema Measure)
change of the POEM
Time frame: screening (baseline), 3, 4, 6 and 12 months from the start of therapy
CSMS (Combined Symptom and Medication Score)
change of the CSMS
Time frame: screening (baseline), 3, 4, 6 and 12 months from the start of therapy
VAS (Visual Analog Scale)
change of the VAS
Time frame: screening (baseline), 3, 4, 6 and 12 months from the start of therapy
ACT (Asthma Control Test)
change of the ACT
Time frame: screening (baseline), 3, 4, 6 and 12 months from the start of therapy
Concentration in the biochemical blood test of total IgE and specific IgE for food and household allergens
change in the Concentration in the biochemical blood test of total IgE, specific IgE-method ImmunoCap to food and household allergens
Time frame: screening (baseline), 3, 4, 6 and 12 months from the start of therapy
Plan to share: Undecided
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This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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National Medical Research Center for Children's Health, Russian Federation