An Open-label, Single-arm Interventional Study to Evaluate the Safety and Efficacy of a Probiotic-containing Cream in Children With Dry Skin | NCT07713303

NCT07713303

Overview

NCT ID: NCT07713303
Lead Sponsor: BioGaia ABINDUSTRY
Official Title: An Open-label, Single-arm Interventional Study to Evaluate the Safety and Efficacy of a Probiotic-containing Cream in Children With Dry Skin
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.
Conditions: Dry Skin

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.

Central Contacts: Sofia Nordh, PhDContact
son@biogaianewsciences.com+46 (0)8 555 293 00