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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-000196-23-IT
Enrollment
Unknown
Registered
2008-08-05
Start date
2008-10-14
Completion date
Unknown
Last updated
2013-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Product Name: SLITOne Pharmaceutical Form: Oromucosal solution INN or Proposed INN: House dust Concentration unit: % percent Concentration type: equal Concentration number: 0-

Sponsors

ALK-ABELLO'
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Pediatric subjects (age >5 and 8 e &#8804;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

Exclusion criteria: severe or uncontrolled asthma Food allergy immunotherapy in the last years

Design outcomes

Primary

MeasureTime frame
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—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026