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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07713303

Acronym

DERMA KIDS

Enrollment

Registered

2026-07-20

Start date

2026-09-01

Completion date

2027-02-01

Last updated

2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Skin

Keywords

dry skin, probiotic, pediatric, ODS, ointment

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.

Interventions

OTHERProbiotic Ointment

Probiotic Ointment

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

0 Months to 7 Years

Healthy volunteers

Inclusion criteria

1. Newborn - 7 years. 2. ODS ≥ 2 in the target area. 3. Parent/guardian able to comply with weekly diaries/photos and visits. 4. Signed ICF by parent/legal guardian; assent as required.

Exclusion criteria

1. Topical medicated treatments on target area within 2 weeks. 2. Active skin infection or severe eczema flare at target site. 3. Known allergy to product components. 4. Participation in another study within 30 days. 5. Any condition judged by investigator to preclude participation.

Design outcomes

Primary

Measure	Time frame	Description
Primary objective	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

Measure	Time frame	Description
Secondary objective	From baseline to week 4	Evaluate change in Specified Symptom Sum Score (SRRC) from baseline to Week 4.

Countries

Portugal

Contacts

CONTACTSofia Nordh, PhD

son@biogaianewsciences.com+46 (0)8 555 293 00

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 21, 2026