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

• Status: Completed
• Trial end date: 2020-04-25
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Medical Research Center for Children's Health, Russian Federation
• Treatments: Methylprednisolone; Methylprednisolone aceponate; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Pimecrolimus; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

1. 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);

2. A burdened family allergic history (at least one of the parents has atopic dermatitis, food allergy, bronchial asthma and / or allergic rhinitis);

3. 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:

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

2. A history of concomitant severe neurological, endocrinological, cardiovascular, hepatic and renal diseases;

3. The presence of acute bacterial, viral infections;

4. The child's lack of sensitization to detectable food and household allergens;

5. Clinically significant changes in the general analysis of urine, general analysis of blood, biochemical analysis of blood;

6. Refusal to sign an informed consent to participate in the study;

7. Inability to observe the patient during the study.