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

Primary Purpose

Childhood Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Conventional treatment plus DLE
Conventional treatment plus placebo
Sponsored by
National Polytechnic Institute, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Atopic Dermatitis focused on measuring Dialyzable Leukocyte Extracts, Transferon, atopic dermatitis

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Infantil de México, Fedérico Gómez

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Conventional Treatment plus DLE

Conventional treatment plus placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Clinical outcome evaluated by SCORAD
To determine clinical outcome by SCORAD.

Secondary Outcome Measures

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.

Full Information

First Posted
July 11, 2013
Last Updated
July 26, 2013
Sponsor
National Polytechnic Institute, Mexico
Collaborators
Hospital Infantil de Mexico Federico Gomez, Instituto de Oftalmología Fundación Conde de Valenciana
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1. Study Identification

Unique Protocol Identification Number
NCT01902836
Brief Title
Efficacy Study of Dialyzed Leukocytes Extracts to Treat Paediatric Moderate Atopic Dermatitis
Official Title
Efficacy of Human Dialyzed Leukocytes Extracts in Paediatrics Patients With Moderate Atopic Dermatitis.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Polytechnic Institute, Mexico
Collaborators
Hospital Infantil de Mexico Federico Gomez, Instituto de Oftalmología Fundación Conde de Valenciana

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Atopic Dermatitis
Keywords
Dialyzable Leukocyte Extracts, Transferon, atopic dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Treatment plus DLE
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional treatment plus placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Conventional treatment plus DLE
Other Intervention Name(s)
Transferon, Dialyzable Leukocytes Extracts
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
Conventional treatment plus placebo
Intervention Description
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 Measure Information:
Title
Clinical outcome evaluated by SCORAD
Description
To determine clinical outcome by SCORAD.
Time Frame
Day 14
Secondary Outcome Measure Information:
Title
Immunophenotypical changes induced by adjuvant treatment (DLE) (oral Transferon)
Description
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.
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mirna Toledo, MD
Organizational Affiliation
Hospital Infantil de Mexico Federico Gomez
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Infantil de México, Fedérico Gómez
City
México
State/Province
DF
ZIP/Postal Code
06720
Country
Mexico

12. IPD Sharing Statement

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

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