Status:
COMPLETED
Prevention of Development of Transcutaneous Sensitization in Children With Atopic Dermatitis During Their First Year of Life
Lead Sponsor:
National Medical Research Center for Children's Health, Russian Federation
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
2-4 years
Phase:
PHASE4
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 re...
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 calci...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2020
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT04900948
Start Date
December 10 2017
End Date
April 25 2020
Last Update
May 27 2021
Active Locations (1)
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1
National Medical Research Center for Children's Health
Moscow, Russia, 119296