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

Vifor

Status and phase

Completed

Phase 3

Conditions

Atopic Dermatitis

Treatments

Drug: Placebo - Cap

Drug: Broncho-Vaxom

Study type

Interventional

Funder types

Industry

Identifiers

NCT03047954

BV-2002/1

Details and patient eligibility

About

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).

Full description

Children outpatients of both sexes, aged 6 months to 7 years, with AD confirmed by Haniffin-Rajka or Williams et al, and an AD score (SCORAD) between 25 and 70 were included and followed for 9 months. Patients were randomized to receive either Broncho-Vaxom 1 capsule (3.5 mg) per day or the corresponding placebo over 9 months.

Children under general corticotherapy within one month of study start, patients with immunodeficiency, patient's affected body surface area less than 15% or greater than 70% or with known allergy to desonide were excluded.

Outcome measures were a comparisons between the two groups in the number of AD flares during the study after the first month of treatment. Secondary outcome measures were comparisons between the two groups based on SCORAD evolution, area of eczema, amount of corticoids used and parents/investigator assessments.

Enrollment

179 patients

Sex

All

Ages

6 months to 7 years old

Volunteers

No Healthy Volunteers

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