A Randomised, Double-Blind, Placebo-controlled, 32-week, Phase IIa Trial to Investigate the Efficacy of OM-85 Versus Matched Placebo in Reducing Disease Severity Children Aged 3 to 24 Months With Early Clinical Diagnosis of Moderate Atopic Dermatitis
Who is this study for? Children aged 3 to 24 months with early clinical diagnosis of moderate atopic dermatitis
What treatments are being studied? Broncho-Vaxom
Status: Terminated
Location: See all (28) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
Clinical data suggest that treatment with OM-85, by inducing an early contact with bacterial extracts, could modulate the immunity of children with Atopic Dermatitis, and thus play an active role in the treatment of Atopic Dermatitis. The present trial will investigate the influence of administration of OM-85 in the paediatric population younger than 24 months with moderate atopic dermatitis. The efficacy and safety of OM-85 will be evaluated in children aged 3 to 24 months old with moderate Atopic Dermatitis who may benefit from treatment with OM-85. The placebo treatment period will serve as a reference and has been added to establish efficacy and safety.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 3 months
Maximum Age: 2
Healthy Volunteers: f
View:
• Children of either gender, aged 3 to 24 months
• Patients with a clinically confirmed diagnosis of AD (according to Hanifin and Rajka) of moderate severity (EASI 7.1 - 21.0) and lesions covering up to 30% of the body either assessed by Investigator at the Screening/Baseline visit or recently (\<4 weeks prior to Screening/Baseline visit) documented by Investigator and pre-treated with TCS (within last 4 weeks prior to Screening/Baseline visit).
• Atopic Dermatitis onset no longer than 12 months before Screening
• Legally acceptable representatives (i.e. parent(s) or guardians) of subject according to local regulations have provided the appropriate written informed consent. Written informed consent must be provided before any study specific procedures are performed including Screening procedures.
Locations
Other Locations
France
Centre d'investigation clinique GHE
Bron
CHU de Cote de Nacre, Centre de Recherche Clinique Pediatric
Caen
Hopital Hotel Dieu
Nantes
CHU de Nice
Nice
CHU de Poitiers, L'unité de Dermatologie
Poitiers
Mediopole Hopital Mutualiste
Villeurbanne
Germany
ISA - Interdisciplinary Study Association GmbH
Berlin
Universitätsklinikum Bonn
Bonn
Elbe Klinikum Buxtehude
Buxtehude
Universitätsklinikum Dresden
Dresden
Universitätsklinikum Freiburg
Freiburg Im Breisgau
MENSINGDERMA research GmbH
Hamburg
Kinderhautarztpraxis Dr. Marc Pleimes
Heidelberg
Kinderarztpraxis Wirth
Krefeld
Studienzentrum Dr. Beate Schwarz
Langenau
Dermatologische Praxis Dr. Quist
Mainz
Universitätsmedizin Mainz, Zentrum für Kinder- und Jugendmedizin
Mainz
Praxis Dr. Panzer
Mannheim
Hautarztpraxis Burgstrasse
München
Klinikum der Universität München
München
Kinderpneumologische Praxis Dr. Funck
Neuss
Kinderärztliche Gemeinschaftspraxis Bedikian und Bouikidis
Oberhausen
Kinderarztpraxis Dres. Med. Sören Westerholt & Jan Matyas
Wolfsburg
Netherlands
Erasmus MC University Department of Dermatology
Rotterdam
St. Franciscus Gasthuis & Vlietland Kindergeneeskunde
Rotterdam
Poland
Dermoklinika Centrum Medyczne
Lodz
Dermedic Jacek Zdybski
Ostrowiec Świętokrzyski
Kliniczny Szpital Woiewodzki
Rzeszów
Time Frame
Start Date:2021-12-20
Completion Date:2023-07-13
Participants
Target number of participants:63
Treatments
Experimental: OM-85
Daily administration of OM-85 (Broncho-Vaxom) 3.5 mg capsules