Volume 7 Supplement 1

2013 WAO Symposium on Immunotherapy and Biologics

Open Access

Poster 1026: Randomized clinical trial to evaluate oral dializable leukocyte extracts as immunemodulator treatment in atopic dermatitis

  • Alejandro Estrada García1,
  • Jorge Galicia Carreón2,
  • Erika Ramírez3,
  • Mirna Toledo3,
  • Sergio Estrada Parra1,
  • Mayra Pérez Tapia1 and
  • María Del Carmen Jiménez Martínez4
World Allergy Organization Journal20147:34

https://doi.org/10.1186/1939-4551-7-S1-P16

Published: 3 February 2014

Background

To investigate efficacy and safety of Dialyzed Leukocyte Extracts (DLE) as adjuvant therapy for moderate atopic dermatitis (AD).

Design

Double blind, placebo-controlled, randomized, clinical single-centre trial.

Methods

Fifty-eight paediatric-patients with moderate AD were enrolled and randomized in two groups: 1) Conventional treatment (CT) + DLE: Cetirizine (0.25mg/kg), once daily/4 weeks, Chlorpheniramine (0.35 mg/Kg), daily divided in 3 doses/4 weeks; and topical Methylprednisolone 0.1%, twice daily/10 days, then once daily/10 days, and ending every 48h/10 days; plus oral DLE (2mg/5mL), daily/5 days, then every 72h to complete one month. 2) CT + placebo, same dosage and administration. Main outcome measures: Severity of skin lesions evaluated with SCORAD-Index, and immunophenotypical changes at day 14, and at end of treatment.

Results

A significant clinical improvement was observed since day 14 with both, CT and CT + DLE therapy, no significant differences in the main clinical outcome measures were found among groups; however a diminished frequency of CD8+ CD103+ cells, and increased frequency of CLA + cells, was observed in CT + placebo-group.

Conclusions

Adjuvant therapy with DLE was safe and well-tolerated. Despite both groups of patients significant improved after treatment, individuals treated with DLE preserved cell subsets related to skin immunological regulation, and avoided systemic expansion of cells related to skin inflammation.

Authors’ Affiliations

(1)
National Polytechnic Institute, Mexico., Department of Immunology, National School of Biological Sciences
(2)
Faculty of Medicine, National Autonomous University of Mexico, Department of Immunology, Research Unit, “Conde de Valenciana” Foundation, Mexico
(3)
National Autonomous University of Mexico, Paediatrics Dermatology Department, Hospital Infantil de México Federico Gómez, Mexico
(4)
Faculty of Medicine, Universidad Nacional Autónoma de México

Copyright

© García et al; licensee BioMed Central Ltd. 2014

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

Advertisement