Prevention of Development of Transcutaneous Sensitization in Children With Atopic Dermatitis During Their First Year of Life
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 4

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.
    

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,
      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.
    

Intervention name(s): Pimecrolimus cream 1%; cream 0.1% methylprednisolone aceponate
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Pimecrolimus; Methylprednisolone aceponate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pimecrolimus; Methylprednisolone aceponate; Glucocorticoids; Calcineurin Inhibitors; Immunoglobulin E; Infant