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

NCT01902836 | Completed Phase 2 DMC

• 1 other identifier: IC-11-06
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Atopic Dermatitis

Keywords

Dialyzable Leukocyte Extracts; Transferon; atopic dermatitis

Outcome Measures

Primary Outcomes (1)

• Clinical outcome evaluated by SCORAD

  To determine clinical outcome by SCORAD.

  Day 14

Secondary Outcomes (1)

• Immunophenotypical changes induced by adjuvant treatment (DLE) (oral Transferon)

  28 days

Study Arms (2)

Conventional Treatment plus DLE

EXPERIMENTAL

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

Conventional treatment plus placebo

PLACEBO COMPARATOR

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

Interventions

Conventional treatment plus DLE BIOLOGICAL

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

Also known as: Transferon, Dialyzable Leukocytes Extracts

Conventional Treatment plus DLE

Conventional treatment plus placebo BIOLOGICAL

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.

Conventional treatment plus placebo

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Polytechnic Institute, Mexico: lead
• Hospital Infantil de Mexico Federico Gomez: collaborator
• Instituto de Oftalmología Fundación Conde de Valenciana: collaborator

Study Sites (1)

Hospital Infantil de México, Fedérico Gómez

Mexico City, Mexico City, 06720, Mexico

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Mirna Toledo, MD

  Hospital Infantil de Mexico Federico Gomez

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 11, 2013
• First Posted: July 18, 2013
• Study Start: August 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: January 1, 2013
• Last Updated: July 29, 2013

Record last verified: 2013-07

Locations

ME (1)