An Open-label, Single-arm Interventional Study to Evaluate the Safety and Efficacy of a Probiotic-containing Cream in Children With Dry Skin
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- BioGaia AB
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Primary objective
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 0 Months to 7 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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
- Secondary objective(From baseline to week 4)