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NCT Number: NCT07701447

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotic Ointment

Other

Probiotic ointment

Comparator product

Other

Basic lotion

Primary outcomes

  1. Primary Endpoint

    Time frame: 28 days

    To evaluate the change in SCORAD from baseline to Day 28.

Secondary outcomes

  1. Secondary Endpoint

    Time frame: 14 days

    To evaluate the change in SCORAD from baseline to Day 14

  2. Secondary Endpoint

    Time frame: 14 and 28 days

    To evaluate the change in local SCORAD from baseline to Day 14 and Day 28

  3. Secondary Endpoint

    Time frame: 14 and 28 days

    To evaluate the change in skin barrier function (TEWL) from baseline to Day 14 and Day 28

  4. Secondary Endpoint

    Time frame: 14 and 28 days

    To evaluate the change in POEM score from baseline to Day 14 and Day 28

  5. Secondary endpoint

    Time frame: 14 and 28 days

    To evaluate the change in itch NRS from baseline to Day 14 and Day 28

  6. Secondary Endpoint

    Time frame: 28 days

    To evaluate the use of topical corticosteroids during the study period

  7. Secondary Endpoint

    Time frame: 28 Days

    To explore changes in skin microbiota between baseline and Day 28

  8. Secondary Endpoint

    Time frame: 28 days

    To evaluate patient-reported tolerability and reported adverse events during the study period

Study contacts

Contact information is provided by the study sponsor or research team.

Sofia Nordh, PhD

CONTACT

[email protected]

+46 (0)8 555 293 00

Sponsors and collaborators

Lead sponsor

BioGaia AB

Industry

Collaborators

  • Zurko Research

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 14, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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