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

Efficacy of Human Dialyzed Leukocytes Extracts in Paediatrics Patients With 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.

Study Overview

• Status: Completed
• Conditions: Childhood Atopic Dermatitis
• Intervention / Treatment: Biological: Conventional treatment plus DLE; Biological: Conventional treatment plus placebo

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 2

Contacts and Locations

Study Locations

• Mexico
  • DF
    • México, DF, Mexico, 06720
      • Hospital Infantil de México, Fedérico Gómez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

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

Collaborators and Investigators

• Sponsor: National Polytechnic Institute, Mexico
• Collaborators: Hospital Infantil de Mexico Federico Gomez; Instituto de Oftalmología Fundación Conde de Valenciana
• Investigators: Principal Investigator: Mirna Toledo, MD, Hospital Infantil de Mexico Federico Gomez

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (ACTUAL): December 1, 2012
• Study Completion (ACTUAL): January 1, 2013

Study Registration Dates

• First Submitted: July 11, 2013
• First Submitted That Met QC Criteria: July 16, 2013
• First Posted (ESTIMATE): July 18, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): July 29, 2013
• Last Update Submitted That Met QC Criteria: July 26, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: atopic dermatitis; Dialyzable Leukocyte Extracts; Transferon
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: IC-11-06