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.
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.
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.
Single group
Probiotic Ointment
Other interventionProbiotic Ointment
Primary objective
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 objective
Evaluate change in Specified Symptom Sum Score (SRRC) from baseline to Week 4.
Exploratory Objectives
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.
Exploratory objective
Evaluate weekly parent-reported assessments using a weekly questionnaire.
Exploratory objective
To evaluate parent/legal guardian acceptability and satisfaction.
Click on the lead sponsor to view all of their trials.
BioGaia AB
Lead sponsor
W4research
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
