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

PHASE2CompletedINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

December 31, 2012

Study Completion Date

January 31, 2013

Conditions
Childhood Atopic Dermatitis
Interventions
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.

Trial Locations (1)

06720

Hospital Infantil de México, Fedérico Gómez, Mexico City

All Listed Sponsors
collaborator

Hospital Infantil de Mexico Federico Gomez

OTHER

collaborator

Instituto de Oftalmología Fundación Conde de Valenciana

OTHER

lead

National Polytechnic Institute, Mexico

OTHER

NCT01902836 - Efficacy Study of Dialyzed Leukocytes Extracts to Treat Paediatric Moderate Atopic Dermatitis | Biotech Hunter | Biotech Hunter