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

NCT04900948 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2021-05-27

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

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

    lead OTHER_GOV

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
4 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-10
Primary Completion
2020-04-25
Completion
2020-04-25

Countries

  • Russia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04900948 on ClinicalTrials.gov