Prevention of Development of Transcutaneous Sensitization in Children With Atopic Dermatitis During Their First Year of Life

NCT04900948 | Completed Phase 4

• 1 other identifier: 13684925
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

This experimental non-randomized clinical study is aimed at comparing the efficacy and safety assessment of the proposed topical therapy algorithms with the use of topical calcineurin inhibitors in reducing the severity of atopic dermatitis and the degree of development of transcutaneous sensitization in children of the first year of life.

Conditions

Atopic Dermatitis

Keywords

Pimecrolimus; Methylprednisolone aceponate; Glucocorticoids; Calcineurin Inhibitors; Immunoglobulin E; Infant

Outcome Measures

Primary Outcomes (4)

• Change from baseline response based on the specific IgE level at 6 months

  Assessment of change of specific IgE level for investigated food / household allergens in serum by ImmunoCAP

  6 months of life

• Change from baseline response based on the specific IgE level at 12 months

  Assessment of change of specific IgE level for investigated food / household allergens in serum by ImmunoCAP

  12 months of life

• Change from baseline response based on the class of sensitization at 6 months

  Assessment of change of the class of sensitization to food / household allergens by ImmunoCAP

  6 months of life

• Change from baseline response based on the class of sensitization at 12 months

  Assessment of change of the class of sensitization to food / household allergens by ImmunoCAP

  12 months of life

Secondary Outcomes (2)

• Change in the Eczema Area and Severity Index (EASI) from baseline

  6 months of age, 9 months of age, 12 months of age

• Incidence of Adverse events leading to discontinuation

  From Baseline up to 12 months of life

Study Arms (2)

Experimental group №1

EXPERIMENTAL

proactive therapy with local calcineurin inhibitors + emollients

Drug: Pimecrolimus cream 1%

Experimental group №2

ACTIVE COMPARATOR

proactive therapy with local glucocorticosteroids + emollients

Drug: cream 0.1% methylprednisolone aceponate

Interventions

Pimecrolimus cream 1% DRUG

Patients received pimecrolimus cream 1% 2 times a day for 3 months. Then use in a double application mode (morning / evening) 3 times a week for up to 1 year of age. Also, patients used emollients 1-2 times a day.

Experimental group №1

cream 0.1% methylprednisolone aceponate DRUG

Patients received 0.1% methylprednisolone aceponate cream 2 times a week for 3 months, and then used for exacerbation of atopic dermatitis. Also, patients used emollients 1-2 times a day.

Experimental group №2

Eligibility Criteria

• Age: 2 Months - 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The severity of atopic dermatitis according to the EASI index (Eczema Area and Severity Index, index of prevalence and severity of eczema)\> 7 points (moderate and / or severe course of atopic dermatitis);
• A burdened family allergic history (at least one of the parents has atopic dermatitis, food allergy, bronchial asthma and / or allergic rhinitis);
• The presence of sensitization in the child to one or more of the studied food and household allergens, determined at the screening stage by the ImmunoCAP method: cow's milk protein, chicken egg protein, wheat, soy, hx2 "house dust mixture: Dermatophagoides pteronyssinus, D. farinae, Blatella germanica ".

You may not qualify if:

• A history of concomitant severe neurological, endocrinological, cardiovascular, hepatic and renal diseases;
• The presence of acute bacterial, viral infections;
• The child's lack of sensitization to detectable food and household allergens;
• Clinically significant changes in the general analysis of urine, general analysis of blood, biochemical analysis of blood;
• Refusal to sign an informed consent to participate in the study;
• Inability to observe the patient during the study.

Sponsors & Collaborators

• National Medical Research Center for Children's Health, Russian Federation: lead

Study Sites (1)

National Medical Research Center for Children's Health

Moscow, 119296, Russia

Location

Related Publications (1)

• Murashkin NN, Namazova-Baranova LS, Makarova SG, Ivanov RA, Grigorev SG, Fedorov DV, Ambarchian ET, Epishev RV, Materikin AI, Opryatin LA, Savelova AA. Observational study of pimecrolimus 1% cream for prevention of transcutaneous sensitization in children with atopic dermatitis during their first year of life. Front Pediatr. 2023 Apr 25;11:1102354. doi: 10.3389/fped.2023.1102354. eCollection 2023.

  PMID: 37181420 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

methylprednisolone aceponate

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 25, 2021
• Study Start: December 10, 2017
• Primary Completion: April 25, 2020
• Study Completion: April 25, 2020
• Last Updated: May 27, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)