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

Starting soon · Not applicable

Conditions studied: Dry Skin

In brief

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 facts

Study ID

NCT07713303

Run by

BioGaia AB

People needed

40

Starts

2026-09-01

Expected to finish

2027-02-01

Last updated by the study team

2026-07-20

Who can join

Age: any, up to 7. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Luciadas — Lisbon, Portugal

Full record on ClinicalTrials.gov

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