Atopic Dermatitis

Broncho-Vaxom (OM 85 BV) in Children Suffering From Atopic Dermatitis

NCT03047954 | PHASE 3 | INTERVENTIONAL

The objective of this pilot double-blind study was to evaluate the efficacy and the safety of Broncho-Vaxom 1 capsule (3.5 mg) per day for 9 months compared to placebo on the evolution of the disease in children suffering from Atopic Dermatitis (AD).

0 Sites

179 Participants

Recruiting

6 Months to 7 Years

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Study Eligibility Criteria

Inclusion Criteria

* Male or female children aged 6 months to 7 years (in eighth year of life)
* Children with Atopic Dermatitis (Hanifin-Rajka or Williams et al criteria) with affected body surface area ≥15% and ≤ 70%
* 25 ≤ SCORAD ≤ 70
* Written informed consent obtained from the parents/legal Guardian (and the child if applicable)

Exclusion Criteria

* Children under general corticotherapy within one month of study start
* Children with immunodeficiency
* Children with malignant disease
* Children with SCORAD\<25 or \>70
* Children with affected body surface area \< 15% or \>70%
* Children with autoimmune disease
* Children under immunosuppressive or immunostimulating therapy within 1 month of study start
* Children whose parents or Guardians are unable to comply with the requirements of the protocol e.g.completion of patient's diary card
* Children with a known allergy or previous intolerance or known hypersensitivity to the trial drug or any of the corticoids used
* Participation in another clinical trial and/or treatment with an experimental drug within 3 months of study start and during present trial

Additional Studies

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