Broncho-Vaxom (OM 85 BV) in Children Suffering From Atopic Dermatitis
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|ClinicalTrials.gov Identifier: NCT03047954|
Recruitment Status : Completed
First Posted : February 9, 2017
Last Update Posted : February 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis||Drug: Broncho-Vaxom Drug: Placebo - Cap||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||179 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Multicentre, Randomised, Double Blind, Placebo-controlled Study of the Efficacy and Safety of Broncho-Vaxom (OM 85 BV) in Children Suffering From Atopic Dermatitis|
|Study Start Date :||July 2003|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||December 2006|
1 capsule (3.5 mg) per day, administered over 9 months
BV is an orally administered immunostimulating preparation, which consists of a lyophilised bacterial extract prepared from 8 bacterial species (Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae and ozaenae, Staphylococcus aureus, Streptococcus pyogenes and viridans, Neisseria catarrhalis)
Placebo Comparator: Placebo
Matching placebo capsule
Drug: Placebo - Cap
Matching Placebo capsule administered
- Number of Atopic Dermatitis (AD) flares over 9 months of treatment [ Time Frame: 9 months ]Comparison between experimental and Placebo arms in the number of AD flares
- SCORAD Evolution over 9 months of treatment [ Time Frame: 9 months ]Comparison between experimental and Placebo arms in SCORAD evolution over 9 months of treatment
- Area of eczema involvement [ Time Frame: 9 months ]Comparison between experimental and Placebo arms in eczema involvement by measurement and recording of total body surface area affected at 3 monthly intervals as compared with baseline
- Amount of corticosteroids used [ Time Frame: 9 months ]Comparison between experimental and Placebo arms in amount of corticosteroids used
- Incidence of treatment emergent adverse events [ Time Frame: 9 months ]measurement of vital signs, results of physical examinations, number and severity of adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03047954
|Principal Investigator:||Yves De Prost, MD||Hopital Necker-Enfants Malades|