Poster 1026: Randomized clinical trial to evaluate oral dializable leukocyte extracts as immunemodulator treatment in atopic dermatitis
- 810 Downloads
KeywordsAdjuvant Therapy Atopic Dermatitis Methylprednisolone Skin Inflammation Conventional Treatment
To investigate efficacy and safety of Dialyzed Leukocyte Extracts (DLE) as adjuvant therapy for moderate atopic dermatitis (AD).
Double blind, placebo-controlled, randomized, clinical single-centre trial.
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.
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.
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.
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.