NCT01902836

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: National Polytechnic Institute, Mexico · Academic / Other
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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
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.

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-12-01
• Completion: 2013-01-01
• First posted: 2013-07-18
• Last updated: 2013-07-29

Locations

1 site across 1 country: Mexico