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

Childhood Atopic Dermatitis Clinical Trial

Official title:

Efficacy of Human Dialyzed Leukocytes Extracts in Paediatrics Patients With Moderate Atopic Dermatitis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01902836
• Other study ID #: IC-11-06
• Status: Completed
• Phase: Phase 2
• First received: July 11, 2013
• Last updated: July 26, 2013
• Start date: August 2011
• Est. completion date: January 2013

Study information

• Verified date: July 2013
• Source: National Polytechnic Institute, Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 17 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Childhood Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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
• 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.

Locations

Country	Name	City	State
Mexico	Hospital Infantil de México, Fedérico Gómez	México	DF

Sponsors (3)

Lead Sponsor	Collaborator
National Polytechnic Institute, Mexico	Hospital Infantil de Mexico Federico Gomez, Instituto de Oftalmología Fundación Conde de Valenciana

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical outcome evaluated by SCORAD	To determine clinical outcome by SCORAD.	Day 14	No
Secondary	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	No