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Not yet recruitingNCT07713303DERMA KIDSUpdated Nov 9, 2026

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

An interventional study of Probiotic Ointment in Dry Skin, sponsored by BioGaia AB. Not yet recruiting at 1 site in Portugal. Open to participants aged 0 Months to 7 Years. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by BioGaia AB · Not applicable, Interventional, and Treatment

Updated Nov 9, 2026Start date movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
0 Months to 7 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Dry Skin

Keywords

  • dry skin
  • probiotic
  • pediatric
  • ODS
  • ointment
03

In context

Lead sponsor

BioGaia AB is the lead sponsor of 20 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Months to 7 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Active

    Probiotic Ointment

    Other: Probiotic Ointment

Interventions

  • OtherProbiotic Ointment

    Probiotic Ointment

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From Baseline to Week 4

Secondary outcomes

  1. Secondary objective

    Evaluate change in Specified Symptom Sum Score (SRRC) from baseline to Week 4.

    Time frame: From baseline to week 4

Other outcomes

  1. 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.

    Time frame: From baseline to week 4

  2. Exploratory objective

    Evaluate weekly parent-reported assessments using a weekly questionnaire.

    Time frame: From baseline to week 4

  3. Exploratory objective

    To evaluate parent/legal guardian acceptability and satisfaction.

    Time frame: Parent/legal guardian acceptability and satisfaction results summarized descriptively, during the study period

07

Study locations

1 site
  • Luciadas
    Lisbon, Portugal
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Start is estimated for Dec 2026; primary completion for Feb 2027, 2 months later.

Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Dec 2026, on Nov 9, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jul 8, 2026
First posted
Jul 20, 2026
StartEst.
Dec 1, 2026was Sep 2026
Primary completionEst.
Feb 1, 2027
CompletionEst.
Feb 1, 2027
Last update
Nov 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Sep 1, 2026→Dec 1, 2026
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    Start date Sep 1, 2026→Dec 1, 2026

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07713303
Lead sponsor
BioGaia AB
Collaborators
W4research
Responsible party
Sponsor
First posted
Jul 20, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Feb 1, 2027 (estimated)
Completion
Feb 1, 2027 (estimated)
Last update
Nov 9, 2026

Study contacts

Sofia Nordh, PhD
Contact
son@biogaianewsciences.com
+46 (0)8 555 293 00

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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BioGaia AB

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