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

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ClinicalTrials.gov Identifier: NCT01902836
Recruitment Status : Completed
First Posted : July 18, 2013
Last Update Posted : July 29, 2013
Sponsor:
Collaborators:
Hospital Infantil de Mexico Federico Gomez
Instituto de Oftalmología Fundación Conde de Valenciana
Information provided by (Responsible Party):
Maria C Jimenez Martinez, Instituto de Oftalmología Fundación Conde de Valenciana

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.

Condition or disease Intervention/treatment Phase
Childhood Atopic Dermatitis Biological: Conventional treatment plus DLE Biological: Conventional treatment plus placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Human Dialyzed Leukocytes Extracts in Paediatrics Patients With Moderate Atopic Dermatitis.
Study Start Date : August 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Conventional Treatment plus DLE

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

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

Placebo Comparator: Conventional treatment plus placebo

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
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 Outcome Measures :
  1. Clinical outcome evaluated by SCORAD [ Time Frame: Day 14 ]
    To determine clinical outcome by SCORAD.


Secondary Outcome Measures :
  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.




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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01902836


Locations
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Mexico
Hospital Infantil de México, Fedérico Gómez
México, DF, Mexico, 06720
Sponsors and Collaborators
National Polytechnic Institute, Mexico
Hospital Infantil de Mexico Federico Gomez
Instituto de Oftalmología Fundación Conde de Valenciana
Investigators
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Principal Investigator: Mirna Toledo, MD Hospital Infantil de Mexico Federico Gomez

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Responsible Party: Maria C Jimenez Martinez, PhD, Instituto de Oftalmología Fundación Conde de Valenciana
ClinicalTrials.gov Identifier: NCT01902836     History of Changes
Other Study ID Numbers: IC-11-06
First Posted: July 18, 2013    Key Record Dates
Last Update Posted: July 29, 2013
Last Verified: July 2013

Keywords provided by Maria C Jimenez Martinez, Instituto de Oftalmología Fundación Conde de Valenciana:
Dialyzable Leukocyte Extracts
Transferon
atopic dermatitis

Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cetirizine
Chlorpheniramine
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents