National Medical Research Center for Children's Health, Russian Federation
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.
Atopic Dermatitis
Pimecrolimus cream 1%
cream 0.1% methylprednisolone aceponate
PHASE4
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, D. 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 Type : | INTERVENTIONAL |
| Estimated Enrollment : | 108 participants |
| Masking : | NONE |
| 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 : | 2017-12-10 |
| Estimated Primary Completion Date : | 2020-04-25 |
| Estimated Study Completion Date : | 2020-04-25 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 2 Months to 4 Months |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
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National Medical Research Center for Children's Health
Moscow, Russian Federation, 119296