Efficacy and Tolerability of a Probiotic Ointment
1 other identifier
interventional
92
0 countries
N/A
Brief Summary
This study evaluates the tolerability and efficacy of a probiotic ointment compared with a comparator lotion in children with atopic dermatitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2026
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2026
CompletedFirst Posted
Study publicly available on registry
July 14, 2026
CompletedStudy Start
First participant enrolled
August 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2028
July 15, 2026
July 1, 2026
2.3 years
July 8, 2026
July 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary Endpoint
To evaluate the change in SCORAD from baseline to Day 28.
28 days
Secondary Outcomes (8)
Secondary Endpoint
14 days
Secondary Endpoint
14 and 28 days
Secondary Endpoint
14 and 28 days
Secondary Endpoint
14 and 28 days
Secondary endpoint
14 and 28 days
- +3 more secondary outcomes
Study Arms (2)
Probiotic Ointment
EXPERIMENTALProbiotic Ointment 2x day
Comparator Product
EXPERIMENTALComparator product 2x day
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BioGaia ABlead
- Zurko Researchcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2026
First Posted
July 14, 2026
Study Start
August 1, 2026
Primary Completion (Estimated)
November 1, 2028
Study Completion (Estimated)
November 1, 2028
Last Updated
July 15, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share