Efficacy of sublingual immunotherapy with HDM mix extract (Der p and Der f) (SLITone) in pediatric subjects with mild-to-moderate atopic eczema (AE) and sensitization to HDM (SPT positive). - SLO-AD-1 Italy

• Conditions: Moderate/severe persistent Atopic Eczema (SCORAD >8 and <40)in patients sentitized to HDM; MedDRA version: 9.1Level: SOCClassification code 10040785; MedDRA version: 9.1Level: SOCClassification code 10038738; MedDRA version: 9.1Level: SOCClassification code 10021428

• Registration Number: EUCTR2008-000196-23-IT
• Lead Sponsor: ALK-ABELLO'

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-05
• Last Update Posted: 29 July 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Pediatric subjects (age >5 and <18 years) Moderate/severe persistent Atopic Eczema (SCORAD >8 e ≤40) with or without mild to moderate asthma and rhinitis. SPT AND APT positive (i.e. wheal diameter >3 mm) to HDM extract (Der p and Der f). Specific IgE to Dermatophagoides (III Class)
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

severe or uncontrolled asthma Food allergy immunotherapy in the last years

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess efficacy, safety and tolerability of SlitOne HDM in pediatric subjects with Atopic Eczema (AE) and HDM sensitization.;Secondary Objective: Effects of SLITOne on possible concomitant allergic rhinitis and asthma Drugs consumption score Safety and tolerability of SLITOne SLITOne Compliance;Primary end point(s): SLITOne efficacy by SCORAD and VAS evaluation