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

NCT ID: NCT01902836

Last Updated: 2013-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2013-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Conventional treatment plus DLE

Intervention Type: 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

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.

Group Type: PLACEBO_COMPARATOR

Conventional treatment plus placebo

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Transferon; Dialyzable Leukocytes Extracts

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Infantil de Mexico Federico Gomez

OTHER

Sponsor Role: collaborator

Instituto de Oftalmología Fundación Conde de Valenciana

OTHER

Sponsor Role: collaborator

National Polytechnic Institute, Mexico

OTHER

Sponsor Role: lead

Responsible Party

Maria C Jimenez Martinez

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mirna Toledo, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Infantil de Mexico Federico Gomez

Locations

Hospital Infantil de México, Fedérico Gómez

Mexico City, Mexico City, Mexico

Countries

Mexico

Other Identifiers

IC-11-06

Identifier Type: -

Identifier Source: org_study_id