Using a special emollient to reduce atopic dermatitis in young children

A Randomised Trial of an Emollient Containing Postbiotic Saccharomyces and Lactobacillus for Improving Clinical Symptoms of Atopic Dermatitis Aged 0-6 Years in Remission

This study is testing if a special lotion with good bacteria can help young children with atopic dermatitis keep their skin clear and healthy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 98 (estimated)
• Ages: 1 Month to 6 Years
• Sex: All
• Sponsor: Children's Hospital of Fudan University (Academic / other)
• Drugs / interventions: methotrexate
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT06474728 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of an emollient containing postbiotic Saccharomyces and Lactobacillus in preventing the recurrence of atopic dermatitis in pediatric patients aged 0-6 years. A total of 98 children with moderate atopic dermatitis were randomly assigned to either the experimental group, which received the special emollient, or the control group, which received standard care. The study measures various outcomes, including the recurrence of atopic dermatitis, skin barrier function, and quality of life assessments over a 12-week intervention period.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 0-6 years with moderate atopic dermatitis who have not used topical medications recently.

Not a fit: Patients with severe atopic dermatitis or those currently using topical medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the recurrence of atopic dermatitis in young children, improving their skin health and quality of life.

How similar studies have performed: While similar approaches have been explored, this specific combination of postbiotics in emollients is relatively novel and has not been extensively tested in this context.

Eligibility criteria

Inclusion Criteria:

1. Participants must meet the diagnostic criteria established by Williams.
2. 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 between 2 and 3.
3. Age range is 0 to 6 years, with no gender restrictions.
4. Guardians of the participants must be willing to apply the test product to the participants as directed by the physician throughout the study period.
5. 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.
6. 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.
7. Participants are not allowed to use other similar products during the entire study period.
8. 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.

Exclusion Criteria:

1. Do not meet the diagnostic criteria established by Williams.
2. Children with acute exacerbation characterized by erosion, exudation, or secondary infection.
3. Presence of open skin infections (bacterial, viral, or fungal) at the application site.
4. Children currently participating in other clinical studies or having participated within the last 3 months.
5. 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.
6. Children who have received non-steroidal immunosuppressants (e.g., cyclosporine, methotrexate) or phototherapy, systemic corticosteroids, or systemic antihistamines within 4 weeks prior to enrollment.
7. Children with severe immune system disorders (such as lymphoma, AIDS, Wiskott-Aldrich syndrome) or a history of malignant tumors.
8. Children with severe heart, liver, or kidney diseases.
9. Children with other skin diseases in the treatment area besides atopic dermatitis.
10. Known allergy to hydrocortisone butyrate cream or the test product.
11. Poor compliance of the subject, known inability to attend visits on time, or unwillingness to comply with the study protocol during the study period.
12. Any condition or previous/concurrent treatment that makes the subject ineligible for this study.

Where this trial is running

Shanghai, Shanghai

• Department of Dermatology,Children's Hospital of Fudan University — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Ming Li, MD

Conditions Atopic Dermatitis; Eczema; Emollient