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

Sponsor

National Medical Research Center for Children's Health, Russian Federation (Other)

Overall Status

Completed

CT.gov ID

NCT04900948

Collaborator

(none)

108

Enrollment

Location

Arms

28.5

Actual Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Drug: Pimecrolimus cream 1% Drug: cream 0.1% methylprednisolone aceponate	Phase 4

Detailed Description

This experimental non-randomized clinical study is aimed at comparing the efficacy and safety assessment of the proposed topical therapy algorithms using topical glucocorticosteroids and 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. The study included more than 100 children aged 2 to 4 months, who, depending on the decision of the researcher, were divided into two groups. During the period of acute manifestations / exacerbation of atopic dermatitis, patients of both groups received basic therapy, which included the use of a topical glucocorticosteroid (0.1% methylprednisolone aceponate cream) 2 times a day in combination with emollients 2 times a day for 10 days. After the relief of acute inflammatory manifestations, the patients were prescribed proactive therapy, including the use of a topical calcineurin inhibitor or a topical glucocorticosteroid, as a result of which comparison groups were formed. Group No. 1, after the end of basic therapy, received a topical calcineurin inhibitor (1% cream pimecrolimus), which was prescribed in the mode 2 times a day for 3 months, and then in the mode of double application (morning / evening) 3 times a week for up to 1 year. life; Group No. 2 after the end of basic therapy received a topical glucocorticosteroid (methylprednisolone aceponate 0.1%) 2 times a week for 3 months, and then - with exacerbation of AD. Patients of both groups used emollients for a long time in the mode 1-2 times a day. The safety and efficacy of the assigned algorithm was assessed by an investigator at the center. Efficacy was measured using the EASI (Eczema Area and Severity Index) score at screening and then at 6, 9 and 12 months of age. And also by tracking the dynamics of the class and level of sIgE to food (cow's milk protein, chicken egg protein, wheat, soy) and household (hx2 "house dust mixture: Dermatophagoides pteronyssinus,

farinae, Blatella germanica") allergens using an automated immunological analyzer ImmunoCAP250 (UniCAP System / Phadia AB, Thermo Fisher Scientific, Sweden) at the time of screening and then at 6 and 12 months of age.

Study Design

Study Type:

Interventional

Actual Enrollment :

108 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Prevention of Development of Transcutaneous Sensitization in Children With Atopic Dermatitis During Their First Year of Life: an Observational Study

Actual Study Start Date :

Dec 10, 2017

Actual Primary Completion Date :

Apr 25, 2020

Actual Study Completion Date :

Apr 25, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group №1 proactive therapy with local calcineurin inhibitors + emollients	Drug: Pimecrolimus cream 1% 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.
Active Comparator: Experimental group №2 proactive therapy with local glucocorticosteroids + emollients	Drug: cream 0.1% methylprednisolone aceponate 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.

Arm

Intervention/Treatment

Experimental: Experimental group №1

proactive therapy with local calcineurin inhibitors + emollients

Drug: Pimecrolimus cream 1%

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.

Active Comparator: Experimental group №2

proactive therapy with local glucocorticosteroids + emollients

Drug: cream 0.1% methylprednisolone aceponate

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.

Outcome Measures

Primary Outcome Measures

Change from baseline response based on the specific IgE level at 6 months [6 months of life]
Assessment of change of specific IgE level for investigated food / household allergens in serum by ImmunoCAP
Change from baseline response based on the specific IgE level at 12 months [12 months of life]
Assessment of change of specific IgE level for investigated food / household allergens in serum by ImmunoCAP
Change from baseline response based on the class of sensitization at 6 months [6 months of life]
Assessment of change of the class of sensitization to food / household allergens by ImmunoCAP
Change from baseline response based on the class of sensitization at 12 months [12 months of life]
Assessment of change of the class of sensitization to food / household allergens by ImmunoCAP

Secondary Outcome Measures

Change in the Eczema Area and Severity Index (EASI) from baseline [6 months of age, 9 months of age, 12 months of age]
The Eczema Area and Severity Index (EASI) quantifies the severity of a subject's AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. Severity is classified as: 0 = clear; 0.1 - 1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe. The lower the scores the better outcome of the treatment.
Incidence of Adverse events leading to discontinuation [From Baseline up to 12 months of life]
The number of participants who developed side effects that led to withdrawal from participation in the study. Registration of cases and reasons for the cancellation of the used external medicines.

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Months to 4 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 ".

Exclusion Criteria:

Use of topical calcineurin inhibitors (pimecrolimus) in the last 30 days prior to inclusion in the study;
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.