Dry SkinDERMA KIDSNCT07713303
An Open-label, Single-arm Interventional Study to Evaluate the Safety and Efficacy of a Probiotic-containing Cream in Children With Dry Skin
A study testing Probiotic Ointment in people with Dry Skin, run by BioGaia AB at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 months to 7 years
- Conditions the study is for
- Dry Skin
- What is being tested?
- Probiotic Ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Sep 2026to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 months to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- Probiotic Ointment
- Keywords
- dry skin, probiotic, pediatric, ODS, ointment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic OintmentOther
Probiotic Ointment
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Probiotic Ointment Receives: Other: Probiotic Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Baseline to Week 4
Secondary outcomes (1)
Secondary objective
Evaluate change in Specified Symptom Sum Score (SRRC) from baseline to Week 4.
Measured: From baseline to week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioGaia AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- W4research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713303
- Sponsor's protocol ID
- DERMA KIDS
- Acronym
- DERMA KIDS
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07713303
- Acronym / sponsor ID
- DERMA KIDS / DERMA KIDS
- Conditions
- Dry Skin
- Keywords
- dry skin, probiotic, pediatric, ODS, ointment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- BioGaia ABIndustry (pharma, biotech, devices)
- Collaborators
- W4research
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Other: Probiotic OintmentProbiotic Ointment |
Who may qualify
- Ages
- 0 months to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic OintmentProbiotic Ointment | Other | Active |
Primary outcome
Primary objective
Time frame: 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.
1 secondary outcome
Secondary objective
Time frame: From baseline to week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic Ointment in people with Dry Skin, run by BioGaia AB at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sofia Nordh, PhD (+46 (0)8 555 293 00, son@biogaianewsciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary objective (time frame: From Baseline to Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.