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Status unknownNCT04895423Updated May 20, 2021

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

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

The sponsor has not verified this record recently (last verified May 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
160
Allocation
Non-randomized
Ages
6 Years to 17 Years
Sex
All
01

Study summary

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.

Read the detailed description

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).

02

Conditions studied

  • Atopic Dermatitis

Keywords

  • Glucocorticoids
  • Biologic Drugs
  • Methotrexate
  • Cyclosporine
  • dupilumab
03

In context

Dermatitis, Atopic

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
6 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age over 6 years inclusive;
  2. Atopic dermatitis diagnosed at least 12 months before the start of the study;
  3. Atopic dermatitis of moderate or severe course;
  4. 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:

    1. Oral systemic corticosteroids;
    2. Other systemic immunosuppressive drugs;
    3. Phototherapy, including therapeutic phototherapy (psoralen plus ultraviolet A, ultraviolet B), excimer laser, and self-medication using a tanning bed;
  5. A signed and dated informed consent received from the patient's parents (guardians), as well as from a patient over 14 years of age, to participate in the study.
  6. Ability to attend control visits within the specified time frame

Exclusion criteria

Exclusion Criteria:

  1. Use of other genetically engineered biological preparations in therapy;
  2. Participation in other clinical trials;
  3. The presence of other concomitant skin diseases in the present or in the past, which could affect the assessment of the effect of the study drugs on the course of atopic dermatitis;
  4. The presence of herpetic eczema within 12 months before the start of the study;
  5. A history of two or more cases of herpetic eczema;
  6. The presence in the present of a skin infection for which is required or is being treated with antibiotics for topical use or systemic antibiotics;
  7. Therapy with the following drugs:

    1. Other genetically engineered biological preparations less than 5 half-lives before the start of the study.
    2. Any corticosteroid for oral and parenteral administration and administration, which were in therapy for 2 weeks before enrollment in the study, or the possible need for parenteral injection of corticosteroids during the course of the study.
    3. Intra-articular corticosteroid injection within 2 weeks prior to study enrollment; Note: The use of intranasal or inhaled steroids is permitted throughout the study.
  8. Extensive or complete disability, significantly limiting personal care or determining the inability to carry it out.
  9. Immunodeficiency disease;
  10. The presence in the past or present of any serious and / or unstable disease, which, in the opinion of the investigator, may pose an unacceptable risk to the patient in the case of the use of the investigational drug or interfere with the interpretation of the data;
  11. History of lymphoproliferative disease; or manifestations or symptoms suggesting the possible presence of lymphoproliferative disease, including lymphadenopathy or splenomegaly; either primary or recurrent malignant disease in active form; or remission after a clinically significant malignant disease lasting less than 5 years;
  12. The course of a viral, bacterial, fungal or parasitic infection;
  13. Failure or unwillingness of the patient or patient's parent / caregiver / patient legal guardian to comply with the requirements of research participants throughout the study and / or unwillingness to follow research restrictions / procedures, including the use of data loggers.
  14. Contraindications to the use of adrenaline.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
160 participants (estimated)

Study arms

  • Experimental
    Group №1: Methotrexate therapy

    Drug: Methotrexate therapy

  • Experimental
    Group №2: Mycophenolate mofetil therapy

    Drug: Mycophenolate mofetil therapy

  • Experimental
    Group №3: Cyclosporine therapy

    Drug: Cyclosporine therapy

  • Experimental
    Group №4: Dupilumab therapy

    Drug: Dupilumab therapy

Interventions

  • DrugMethotrexate therapy

    Methotrexate subcutaneously 10-15 mg/m2 once every 7 days within 12 months

  • DrugMycophenolate mofetil therapy

    Mycophenolate mofetil per os 500-700 mg/m2 2 times a day within 12 months

  • DrugCyclosporine therapy

    Cyclosporine per os 3 mg/m2 2 times a day within 12 months

  • DrugDupilumab therapy

    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.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. Adverse events

    Adverse events monitoring

    Time frame: screening (baseline), 3, 4, 6 and 12 months from the start of therapy

Secondary outcomes

  1. 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

  2. POEM (Patient-Oriented Eczema Measure)

    change of the POEM

    Time frame: screening (baseline), 3, 4, 6 and 12 months from the start of therapy

  3. 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

  4. VAS (Visual Analog Scale)

    change of the VAS

    Time frame: screening (baseline), 3, 4, 6 and 12 months from the start of therapy

  5. ACT (Asthma Control Test)

    change of the ACT

    Time frame: screening (baseline), 3, 4, 6 and 12 months from the start of therapy

  6. 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

07

Study locations

1 site
  • National Medical Research Center for Children's Health
    Moscow, 119296, Russian Federation
    • Nikolay Murashkin, DMS · Contact · m_nn2001@mail.ru · +79184951122
    • Mariam Edwardovna · Principal investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04895423
Lead sponsor
National Medical Research Center for Children's Health, Russian Federation
Responsible party
Sponsor
First posted
May 20, 2021
Start date
Nov 25, 2021 (estimated)
Primary completion
Jul 25, 2023 (estimated)
Completion
Jul 25, 2023 (estimated)
Last update
May 20, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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