Efficacy Study of Dialyzed Leukocytes Extracts to Treat Paediatric Moderate Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Efficacy of Human Dialyzed Leukocytes Extracts in Paediatrics Patients With Moderate Atopic Dermatitis.

Conditions
-----------------
Childhood Atopic Dermatitis

Intervention / Treatment
-----------------
* Biological: Conventional treatment plus DLE
* Biological: Conventional treatment plus placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Atopic dermatitis diagnosis by Hanifin and Rajka classification Dermatitis severity: Moderate, according with SCORAD index. Patients without treatment of topical steroids or immunosuppressants in the last 3 weeks. Patients with informed consent form signed by both parents, or advisor. Patients 7 years old or older whom have signed the assent form Exclusion Criteria: Patient who were treated with topical, or systemic steroids and/or immunosuppressants and they cannot discontinue their treatment. Patients who lived far from the hospital and they could not go to the visits.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional Treatment plus DLE<br>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, then every 48h for 10 days and suspend; Dialyzed Leukocyte Extracts as Adjuvant Treatment: oral DLE (Transferon) (2mg/5mL), then every day for 5 days, and then every 72hrs to complete one month. | Biological: Conventional treatment plus DLE<br>* 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<br>* Other names: Dialyzable Leukocytes Extracts;|
| Placebo Comparator: Conventional treatment plus placebo<br>Conventional treatment plus placebo: 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, then every 48h for 10 days and suspend; plus oral placebo, every day for 5 days, then every 72hrs to complete one month. | Biological: Conventional treatment plus placebo<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome evaluated by SCORAD | To determine clinical outcome by SCORAD. | Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dialyzable Leukocyte Extracts, Transferon, atopic dermatitis