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

Status Completed

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03047954
Study type	Interventional
Source	Vifor Inc.
Contact
Status	Completed
Phase	Phase 3
Start date	July 2003
Completion date	December 2006

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05018806` - Proof of Concept Study of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis	Phase 2
Terminated	`NCT03847389` - Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis	Phase 1/Phase 2
Completed	`NCT04090229` - A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneously Delivered ASLAN004 in Adults With Moderate-Severe Atopic Dermatitis	Phase 1
Active, not recruiting	`NCT05388760` - Tralokinumab Monotherapy for Children With Moderate-to-severe Atopic Dermatitis - TRAPEDS 1 (TRAlokinumab PEDiatric Trial no. 1)	Phase 2
Completed	`NCT05530707` - Evaluation of Acceptability, Skin Barrier Restoration and Balance of Atopic Skin Using Moisturizer	N/A
Completed	`NCT02595073` - Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone (DSXS) With Atopic Dermatitis	Phase 3
Recruiting	`NCT05509023` - Evaluating Safety and Efficacy of ADX-914 in Patients With Moderate to Severe Atopic Dermatitis (SIGNAL-AD)	Phase 2
Recruiting	`NCT05048056` - Phase 2 Study of Efficacy and Safety of AK120, in Subjects With Moderate-to-Severe Atopic Dermatitis	Phase 2
Completed	`NCT04598269` - Study of ATI-1777 in Adult Patients With Moderate or Severe Atopic Dermatitis	Phase 2
Recruiting	`NCT03936335` - An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)
Withdrawn	`NCT03089476` - Evaluating Skin Barrier Dysfunction in Infants at High Risk of Atopy	N/A
Recruiting	`NCT05029895` - A Study to Evaluate Adverse Events and Change in Disease State of Oral Upadacitinib in Adolescent Participants Ages 12 to <18 Years Old Diagnosed With Atopic Dermatitis (AD)
Terminated	`NCT03654755` - Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis	Phase 2
Completed	`NCT04556461` - Effects of Tralokinumab Treatment of Atopic Dermatitis on Skin Barrier Function	Phase 2
Recruiting	`NCT04818138` - BROadband vs Narrowband photoTherapy for Eczema Trial Nested in the CACTI Cohort	N/A
Completed	`NCT03719742` - A Clinical Study to Evaluate the Safety and Efficacy of a Baby Cleanser and a Moisturizer	N/A
Completed	`NCT05375955` - A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis.	Phase 2
Completed	`NCT03441568` - In-home Use Test of the New Modified Diprobase Formulation to Assess the Safety and Tolerability in Infants and Children Under Physician's Control	N/A
Recruiting	`NCT06366932` - Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Predictive Models	Phase 4
Completed	`NCT03304470` - A Study to Evaluate the Safety and Efficacy of ATx201 in Subjects With Moderate Atopic Dermatitis	Phase 2