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NCT Number: NCT07713303

An Open-label, Single-arm Interventional Study to Evaluate the Safety and Efficacy of a Probiotic-containing Cream in Children With Dry Skin

The DermaKIDS study is an open-label, single-arm interventional study designed to evaluate the safety and efficacy of a probiotic-containing cream in children with dry skin. Approximately 40 children aged from newborn to 7 years will be enrolled at two study sites in Portugal. Participants will apply the study cream twice daily for a period of four weeks under normal home-use conditions. The primary efficacy endpoint is the change in Overall Dry Skin Score (ODS) from baseline to the end of the study. Safety and efficacy will be assessed through investigator evaluations combined with weekly parent-reported diaries and standardized photographs.

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Key information

Conditions

Dry Skin

Age range

0 month–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Luciadas

Lisbon, Portugal

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Newborn - 7 years.
  • ODS ≥ 2 in the target area.
  • Parent/guardian able to comply with weekly diaries/photos and visits.
  • Signed ICF by parent/legal guardian; assent as required.

Exclusion criteria

  • Topical medicated treatments on target area within 2 weeks.
  • Active skin infection or severe eczema flare at target site.
  • Known allergy to product components.
  • Participation in another study within 30 days.
  • Any condition judged by investigator to preclude participation.

Treatment and study plan

Probiotic Ointment

Other

Probiotic Ointment

Primary outcomes

  1. Primary objective

    Time frame: From Baseline to Week 4

    Evaluate change in Overall Dry Skin Score (ODS) from baseline to Week 4 after regular application (twice daily, every day) of Probiotic skin ointment (Study Product) versus baseline.

Secondary outcomes

  1. Secondary objective

    Time frame: From baseline to week 4

    Evaluate change in Specified Symptom Sum Score (SRRC) from baseline to Week 4.

Other outcomes

  1. Exploratory Objectives

    Time frame: From baseline to week 4

    Document tolerability and local reactions by measuring the number and percentage of participants with adverse events and local skin reactions, number of events, severity, and relationship to the study product.

  2. Exploratory objective

    Time frame: From baseline to week 4

    Evaluate weekly parent-reported assessments using a weekly questionnaire.

  3. Exploratory objective

    Time frame: Parent/legal guardian acceptability and satisfaction results summarized descriptively, during the study period

    To evaluate parent/legal guardian acceptability and satisfaction.

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

  • W4research

Registry information

Acronym: DERMA KIDS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 20, 2026
Registry last updated
Jul 20, 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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