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An Open-label, Single-arm Interventional Study to Evaluate the Safety and Efficacy of a Probiotic-containing Cream in Children With Dry Skin
Sponsor: BioGaia AB
Summary
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.
Key Details
Gender
All
Age Range
0 Months - 7 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-09-01
Completion Date
2027-02-01
Last Updated
2026-07-20
Healthy Volunteers
No
Conditions
Interventions
Probiotic Ointment
Probiotic Ointment
Locations (1)
Luciadas
Lisbon, Portugal