Patients with atopic dermatitis treated with conventional treatment plus Dialyzed Leukocyte Extracts (DLE-oral Transferon) as adjuvant, have better clinical outcome than patients treated only with conventional treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
58
Paediatric patients with diagnosis of atopic dermatitis according to Hanifin and Rajka and evaluated with SCORAD as moderate atopic dermatitis were included. Patients were randomized and received in a double blind placebo-controlled treatment: Group 1: Conventional treatment plus DLE Conventional Treatment: oral Cetirizine 0.25mg/kg, every day, for 4 weeks; chlorpheniramine 0.35 mg/Kg, daily divided in 3 doses, for 4 weeks; and topical Methylprednisolone 0.1% over affected skin area, every 12h for 10 days, then every 24h for 10 days and then every 48h for 10 days and suspend; plus oral DLE (Transferon) (2mg/5mL), every day for 5 days, then every 72hrs to complete one month
Group 2: Conventional treatment plus placebo. Conventional treatment: Cetirizine 0.25mg/kg oral, every day, for 4 weeks; chlorpheniramine 0.35 mg/Kg, daily divided in 3 doses, for 4 weeks; topical Methylprednisolone 0.1% over affected skin area, every 12h for 10 days, then every 24h for 10 days and then every 48h for 10 days and suspend; and oral placebo, every day for 5 days, then every 72hrs to complete one month.
Hospital Infantil de México, Fedérico Gómez
Mexico City, Mexico City, Mexico
Clinical outcome evaluated by SCORAD
To determine clinical outcome by SCORAD.
Time frame: Day 14
Immunophenotypical changes induced by adjuvant treatment (DLE) (oral Transferon)
To evaluate immunophenotypical changes, on peripheral blood mononuclear cells (PBMC) before, at day 14, and end of treatment. Immunophenotypical changes in this study are defined as changes in CLA and CD103 expression on PBMC; and changes in frequency of CD4+CD25+FOXP3 regulatory T cells, before, at day 14, and at end of treatment.
Time frame: 28 days
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