NCT03047954

Brief Summary

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
179

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2003

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
10.1 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2017

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
Last Updated

February 9, 2017

Status Verified

January 1, 2017

Enrollment Period

3.4 years

First QC Date

January 13, 2017

Last Update Submit

February 7, 2017

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • SCORAD Evolution over 9 months of treatment

    9 months

  • Area of eczema involvement

    9 months

  • Amount of corticosteroids used

    9 months

Other Outcomes (1)

  • Incidence of treatment emergent adverse events

    9 months

Study Arms (2)

Broncho-Vaxom

EXPERIMENTAL

1 capsule (3.5 mg) per day, administered over 9 months

Drug: Broncho-Vaxom

Placebo

PLACEBO COMPARATOR

Matching placebo capsule

Drug: Placebo - Cap

Interventions

Broncho-VaxomDRUG

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)

Also known as: Imocur, Broncho-Munal, Ommunal, Paxoral, Vaxoral
Broncho-Vaxom
Placebo - CapDRUG

Matching Placebo capsule administered

Placebo

Eligibility Criteria

Age6 Months - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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%
  • ≤ SCORAD ≤ 70
  • Written informed consent obtained from the parents/legal Guardian (and the child if applicable)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 7918015BACKGROUND

  • 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.

    PMID: 10494710BACKGROUND

  • 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.

    PMID: 8435513BACKGROUND

  • Hanifin JM, Rajka G. Acta Derm Venereol Suppl (Stockh) 1980; 92:44-7

    BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Broncho-Vaxom

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Yves De Prost, MD

    Hopital Necker-Enfants Malades

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2017

First Posted

February 9, 2017

Study Start

July 1, 2003

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

February 9, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share