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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Broncho-Vaxom | Experimental | 1 capsule (3.5 mg) per day, administered over 9 months |
|
| Placebo | Placebo Comparator | Matching placebo capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Broncho-Vaxom | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Atopic Dermatitis (AD) flares over 9 months of treatment | Comparison between experimental and Placebo arms in the number of AD flares | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| SCORAD Evolution over 9 months of treatment | Comparison between experimental and Placebo arms in SCORAD evolution over 9 months of treatment | 9 months |
| Area of eczema involvement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment emergent adverse events | measurement of vital signs, results of physical examinations, number and severity of adverse events | 9 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yves De Prost, MD | Hopital Necker-Enfants Malades | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7918015 | Background | Williams HC, Burney PG, Hay RJ, Archer CB, Shipley MJ, Hunter JJ, Bingham EA, Finlay AY, Pembroke AC, Graham-Brown RA, et al. The U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis. I. Derivation of a minimum set of discriminators for atopic dermatitis. Br J Dermatol. 1994 Sep;131(3):383-96. doi: 10.1111/j.1365-2133.1994.tb08530.x. | |
| 10494710 |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| C030259 | Broncho-Vaxom |
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|
|
| Placebo - Cap | Drug | Matching Placebo capsule administered |
|
| 9 months |
| Amount of corticosteroids used | Comparison between experimental and Placebo arms in amount of corticosteroids used | 9 months |
| Wolkerstorfer A, de Waard van der Spek FB, Glazenburg EJ, Mulder PG, Oranje AP. Scoring the severity of atopic dermatitis: three item severity score as a rough system for daily practice and as a pre-screening tool for studies. Acta Derm Venereol. 1999 Sep;79(5):356-9. doi: 10.1080/000155599750010256. |
| 8435513 | Background | Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology. 1993;186(1):23-31. doi: 10.1159/000247298. |
| Background | Hanifin JM, Rajka G. Acta Derm Venereol Suppl (Stockh) 1980; 92:44-7 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |