Atopic DermatitisNCT06474728
Effects of an Emollient Containing Postbiotic Saccharomyces and Lactobacillus on Pediatric Atopic Dermatitis
A study testing Treatment with an Emollient Containing Postbiotic Saccharomyces and Lactobacillus in people with Atopic Dermatitis and Eczema, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
The goal of this study is to investigate whether the use of emollients containing postbiotic Saccharomyces and Lactobacillus can significantly reduce the risk of atopic dermatitis (AD) recurrence in pediatric patients aged 0-6 years during the remission phase, compared to the routine maintenance treatment with… Read more about this study
- Who is it for?
- Ages 1 month to 6 years
- Conditions the study is for
- Atopic Dermatitis, Eczema, Emollient
- What is being tested?
- Treatment with an Emollient Containing Postbiotic Saccharomyces and Lactobacillus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2024to 6 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 1 month to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants must meet the diagnostic criteria established by Williams.
- Moderate atopic dermatitis is defined by an Eczema Area and Severity Index (EASI) score of 7.1 to 21.0, and an Investigator's Global Assessment (IGA) score of 3.
- Age range is 0 to 6 years, with no gender restrictions.
- Guardians of the participants must be willing to apply the test product to the participants as directed by the physician throughout the study period.
- Participants should not have received topical medication within 14 days prior to enrollment, including calcineurin inhibitors (e.g., topical tacrolimus or pimecrolimus), corticosteroid formulations, or topical antihistamines.
- Within 4 weeks prior to enrollment, participants should not have received non-steroidal immunosuppressants (e.g., cyclosporine, methotrexate) or phototherapy, nor should they have used systemic corticosteroids or systemic antihistamines.
- Participants are not allowed to use other similar products during the entire study period.
- Prior to the commencement of any study-specific examination or procedural step, participants must sign an informed consent form. For infants and young children aged 0 to 6 years, the guardians must sign an informed consent waiver on behalf of the child and also sign a parental version of the informed consent form.
Who cannot join
- Do not meet the diagnostic criteria established by Williams.
- Children with acute exacerbation characterized by erosion, exudation, or secondary infection.
- Presence of open skin infections (bacterial, viral, or fungal) at the application site.
- Children currently participating in other clinical studies or having participated within the last 3 months.
- Children who have received topical medication within 14 days prior to enrollment, including calcineurin inhibitors (e.g., topical tacrolimus or pimecrolimus), corticosteroid formulations, or topical antihistamines.
- Children who have received non-steroidal immunosuppressants (e.g., cyclosporine, methotrexate) or phototherapy, systemic corticosteroids, or systemic antihistamines within 4 weeks prior to enrollment.
Show all 12Show fewer
- Children with severe immune system disorders (such as lymphoma, AIDS, Wiskott-Aldrich syndrome) or a history of malignant tumors.
- Children with severe heart, liver, or kidney diseases.
- Children with other skin diseases in the treatment area besides atopic dermatitis.
- Known allergy to hydrocortisone butyrate cream or the test product.
- Poor compliance of the subject, known inability to attend visits on time, or unwillingness to comply with the study protocol during the study period.
- Any condition or previous/concurrent treatment that makes the subject ineligible for this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Dermatology,Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
About this study
Official title: A Randomised Trial of an Emollient Containing Postbiotic Saccharomyces and Lactobacillus for Improving Clinical Symptoms of Atopic Dermatitis Aged 0-6 Years in Remission
The goal of this study is to investigate whether the use of emollients containing postbiotic Saccharomyces and Lactobacillus can significantly reduce the risk of atopic dermatitis (AD) recurrence in pediatric patients aged 0-6 years during the remission phase, compared to the routine maintenance treatment with conventional emollients.
Read the detailed description
A single-center, randomized, parallel-controlled study was conducted to evaluate the efficacy of an emollient containing postbiotic Saccharomyces and Lactobacillus in 98 children aged 0 to 6 years with moderate AD. Participants were randomly assigned to the experimental group (49 cases) and the control group (49 cases).
During the screening phase, hydrocortisone butyrate cream or desoximetasone cream was topically applied twice daily to the affected areas, along with the emollient twice daily for 2 to 4 weeks until the Investigator's Global Assessment (IGA) score was ≤1, indicating entry into the intervention phase. In the intervention phase, the experimental group discontinued the corticosteroid creams and continued with the emollient twice daily, while the control group discontinued both medication and emollient.
The recurrence of AD, Eczema Area and Severity Index (EASI), Infant/Child Dermatology Quality of Life Index (IDQOL/CDQOL), and adverse events were assessed at weeks 4, 8, and 12 of the intervention phase. Additionally, non-invasive measurements of skin barrier function were conducted, including:
Transepidermal water loss (TEWL) to assess water loss from the skin. Skin electrical capacitance to measure water retention in the stratum corneum. Skin pH to determine the skin's acidity level.
- Conditions
- Atopic Dermatitis, Eczema, Emollient
- Being tested
- Treatment with an Emollient Containing Postbiotic Saccharomyces and Lactobacillus
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with an Emollient Containing Postbiotic Saccharomyces and LactobacillusOther
Treatment with an Emollient Containing Postbiotic Saccharomyces and Lactobacillus, with the dose of 100g per week,lasting for 12weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with an Emollient Containing Postbiotic Saccharomyces and Lactobacillus | Experimental | Not described Receives: Other: Treatment with an Emollient Containing Postbiotic Saccharomyces and Lactobacillus |
| Treatment without an Emollient Containing Postbiotic Saccharomyces and Lactobacillus | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate during the intervention phase
During the intervention phase, when the patient's Investigator's Gobal Assessment (lGA) score reaches 2 or higher, the investigators defined it as recurrence.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start9 Oct 2024
- Primary completion6 Jan 2026
- Study completion6 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474728
- Sponsor's protocol ID
- ADskincare2024
- Status last verified
- Apr 2026
- First submitted
- 20 Jun 2024
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang S, Wang L, Li P, Shu H, Shen C, Wu Y, Luo Z, Miao L, Wang H, Jiao L, Tian J, Peng X, Zhao M, Liu Y, Nie X, He L, Ma L. The improvement of infantile atopic dermatitis during the maintenance period: A multicenter, randomized, parallel controlled clinical study of emollients in Prinsepia utilis Royle. Dermatol Ther. 2020 Mar;33(2):e13153. doi: 10.1111/dth.13153. Epub 2019 Nov 22.
PubMed 31705602
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Trial of an Emollient Containing Postbiotic Saccharomyces and Lactobacillus for Improving Clinical Symptoms of Atopic Dermatitis Aged 0-6 Years in Remission
- ClinicalTrials.gov ID
- NCT06474728
- Acronym / sponsor ID
- ADskincare2024
- Conditions
- Atopic Dermatitis, Eczema, Emollient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 6 Jan 2026 (actual)
- Study completion
- 6 Jan 2026 (actual)
- First posted
- 26 Jun 2024 (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 goal of this study is to investigate whether the use of emollients containing postbiotic Saccharomyces and Lactobacillus can significantly reduce the risk of atopic dermatitis (AD) recurrence in pediatric patients aged 0-6 years during the remission phase, compared to the routine maintenance treatment with conventional emollients.
Detailed description
A single-center, randomized, parallel-controlled study was conducted to evaluate the efficacy of an emollient containing postbiotic Saccharomyces and Lactobacillus in 98 children aged 0 to 6 years with moderate AD. Participants were randomly assigned to the experimental group (49 cases) and the control group (49 cases).
During the screening phase, hydrocortisone butyrate cream or desoximetasone cream was topically applied twice daily to the affected areas, along with the emollient twice daily for 2 to 4 weeks until the Investigator's Global Assessment (IGA) score was ≤1, indicating entry into the intervention phase. In the intervention phase, the experimental group discontinued the corticosteroid creams and continued with the emollient twice daily, while the control group discontinued both medication and emollient.
The recurrence of AD, Eczema Area and Severity Index (EASI), Infant/Child Dermatology Quality of Life Index (IDQOL/CDQOL), and adverse events were assessed at weeks 4, 8, and 12 of the intervention phase. Additionally, non-invasive measurements of skin barrier function were conducted, including:
Transepidermal water loss (TEWL) to assess water loss from the skin. Skin electrical capacitance to measure water retention in the stratum corneum. Skin pH to determine the skin's acidity level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with an Emollient Containing Postbiotic Saccharomyces and Lactobacillus | Experimental | Other: Treatment with an Emollient Containing Postbiotic Saccharomyces and Lactobacillus |
| Treatment without an Emollient Containing Postbiotic Saccharomyces and Lactobacillus | No intervention | – |
Who may qualify
- Ages
- 1 month to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Participants must meet the diagnostic criteria established by Williams.
- Moderate atopic dermatitis is defined by an Eczema Area and Severity Index (EASI) score of 7.1 to 21.0, and an Investigator's Global Assessment (IGA) score of 3.
- Age range is 0 to 6 years, with no gender restrictions.
- Guardians of the participants must be willing to apply the test product to the participants as directed by the physician throughout the study period.
- Participants should not have received topical medication within 14 days prior to enrollment, including calcineurin inhibitors (e.g., topical tacrolimus or pimecrolimus), corticosteroid formulations, or topical antihistamines.
Key exclusion criteria (12 listed)
- Do not meet the diagnostic criteria established by Williams.
- Children with acute exacerbation characterized by erosion, exudation, or secondary infection.
- Presence of open skin infections (bacterial, viral, or fungal) at the application site.
- Children currently participating in other clinical studies or having participated within the last 3 months.
- Children who have received topical medication within 14 days prior to enrollment, including calcineurin inhibitors (e.g., topical tacrolimus or pimecrolimus), corticosteroid formulations, or topical antihistamines.
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 |
|---|---|---|
| Treatment with an Emollient Containing Postbiotic Saccharomyces and LactobacillusTreatment with an Emollient Containing Postbiotic Saccharomyces and Lactobacillus, with the dose of 100g per week,lasting for 12weeks. | Other | Treatment with an Emollient Containing Postbiotic Saccharomyces and Lactobacillus |
Primary outcome
Recurrence rate during the intervention phase
Time frame: 12 weeks
During the intervention phase, when the patient's Investigator's Gobal Assessment (lGA) score reaches 2 or higher, the investigators defined it as recurrence.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Background: PubMed 31705602Wang S, Wang L, Li P, Shu H, Shen C, Wu Y, Luo Z, Miao L, Wang H, Jiao L, Tian J, Peng X, Zhao M, Liu Y, Nie X, He L, Ma L. The improvement of infantile atopic dermatitis during the maintenance period: A multicenter, randomized, parallel controlled clinical study of emollients in Prinsepia utilis Royle. Dermatol Ther. 2020 Mar;33(2):e13153. doi: 10.1111/dth.13153. Epub 2019 Nov 22.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Atopic Dermatitis
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with an Emollient Containing Postbiotic Saccharomyces and Lactobacillus in people with Atopic Dermatitis and Eczema, run by Children's Hospital of Fudan University at 1 site in China.
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 8 inclusion and 12 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: finished, as of the sponsor's last update on 8 Apr 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate during the intervention phase (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06474728, which also lists 1 linked publication.
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 8 Apr 2026.