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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01902836

Enrollment

Registered

2013-07-18

Start date

2011-08-31

Completion date

2013-01-31

Last updated

2013-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Atopic Dermatitis

Keywords

Dialyzable Leukocyte Extracts, Transferon, atopic dermatitis

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.

Interventions

BIOLOGICALConventional 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

BIOLOGICALConventional 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

2 Years to 17 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Clinical outcome evaluated by SCORAD	Day 14	To determine clinical outcome by SCORAD.

Secondary

Measure	Time frame	Description
Immunophenotypical changes induced by adjuvant treatment (DLE) (oral Transferon)	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.

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026