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Completed

NCT Number: NCT01902836

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

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.

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Key information

Conditions

Childhood Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Infantil de México, Fedérico Gómez

Mexico City, 06720, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conventional treatment plus DLE

Biological

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

Other names: Transferon, Dialyzable Leukocytes Extracts

Conventional treatment plus placebo

Biological

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.

Primary outcomes

  1. Clinical outcome evaluated by SCORAD

    Time frame: Day 14

    To determine clinical outcome by SCORAD.

Secondary outcomes

  1. Immunophenotypical changes induced by adjuvant treatment (DLE) (oral Transferon)

    Time frame: 28 days

    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.

Sponsors and collaborators

Lead sponsor

National Polytechnic Institute, Mexico

Other

Collaborators

  • Hospital Infantil de Mexico Federico Gomez
  • Instituto de Oftalmología Fundación Conde de Valenciana

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jul 18, 2013
Registry last updated
Jul 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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