Efficacy and Tolerability of a Probiotic Ointment

This study evaluates the tolerability and efficacy of a probiotic ointment compared with a comparator lotion in children with atopic dermatitis.

Study Overview

• Status: Not yet recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Other: Probiotic Ointment; Other: Comparator product

• Study Type: Interventional
• Enrollment (Estimated): 92
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sofia Nordh, PhD; Phone Number: +46 (0)8 555 293 00; Email: son@biogaianewsciences.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria Male and female pediatric patients aged 0.5 years to 15 years with Atopic Dermatitis.

SCORAD Index at D0 = 15 to 50, inclusive. In goodgeneral health as reported by the parent(s)/legal representative(s). Available for the full duration of the study and willing to comply with procedures.

Subjects whose parents or legal representative are willing to sign the informed consent.

Exclusion Criteria Use of phototherapy for atopic dermatitis. Use of systemic corticosteroids within 2 weeks prior to the study. Use of Immunosuppressive or cytostatic drugs within 1 months prior to the study.

Use of antibiotics (topical and systemic) within 15 days prior to the start of the study.

Subjects who are treated with vitamin A-derived compounds or other topical medications for acne in the experimental area during the 30 days prior to the start of the study.

History of sensitivity to the study products, or its components. History or evidence of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis).

Subjects with active infection in atopic dermatitis areas requiring antibiotics, antifungals, or antiviral agents within 7 days before baseline participation in any study that would interfere with the current study.

Fever (temperature> 37.5 °C axillary or equivalent) during 48 hours prior the start of the study.

Pathologies associated with immunodeficiency or cancer processes. Any concurrent dermatologic or medical conditions that may interfere with the investigators ability to assess the subject's response to the study drug or require the continued use of topical corticosteroids.

Subjects who have received the schedule MMR vaccination during the study period or have received the last dose within three weeks prior the start of the study.

Subjects who participates in any study that would interfere with the current study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic Ointment; Probiotic Ointment 2x day	Other: Probiotic Ointment; Probiotic ointment
Experimental: Comparator Product; Comparator product 2x day	Other: Comparator product; Basic lotion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Endpoint	To evaluate the change in SCORAD from baseline to Day 28.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Endpoint	To evaluate the change in SCORAD from baseline to Day 14	14 days
Secondary Endpoint	To evaluate the change in local SCORAD from baseline to Day 14 and Day 28	14 and 28 days
Secondary Endpoint	To evaluate the change in skin barrier function (TEWL) from baseline to Day 14 and Day 28	14 and 28 days
Secondary Endpoint	To evaluate the change in POEM score from baseline to Day 14 and Day 28	14 and 28 days
Secondary endpoint	To evaluate the change in itch NRS from baseline to Day 14 and Day 28	14 and 28 days
Secondary Endpoint	To evaluate the use of topical corticosteroids during the study period	28 days
Secondary Endpoint	To explore changes in skin microbiota between baseline and Day 28	28 Days
Secondary Endpoint	To evaluate patient-reported tolerability and reported adverse events during the study period	28 days

Collaborators and Investigators

• Sponsor: BioGaia AB

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: July 8, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Microbiome; Probiotic; Atopic Dermatitis; Ointment
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic
• Other Study ID Numbers: BNS_RD_004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No