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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

Study acronym: DERMA KIDS
StatusNot Yet Recruiting
PhaseNot applicable
SponsorBioGaia AB
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
BioGaia AB
8 trials monitored
See 1 trial at risk
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.
Trial Details
NCT Number NCT07713303
Lead Sponsor BioGaia AB
Collaborators: W4research
Conditions
(from sponsor)		 Dry Skin
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov