Effects of an Emollient Containing Postbiotic Saccharomyces and Lactobacillus on Pediatric Atopic Dermatitis

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.

Study Overview

• Status: Completed
• Conditions: Eczema; Atopic Dermatitis; Emollient
• Intervention / Treatment: Other: Treatment with an Emollient Containing Postbiotic Saccharomyces and Lactobacillus

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 Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 201102
      • Department of Dermatology,Children's Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 of 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment with an Emollient Containing Postbiotic Saccharomyces and Lactobacillus	Other: Treatment with an Emollient Containing Postbiotic Saccharomyces and Lactobacillus; Treatment with an Emollient Containing Postbiotic Saccharomyces and Lactobacillus, with the dose of 100g per week,lasting for 12weeks.
No Intervention: Treatment without an Emollient Containing Postbiotic Saccharomyces and Lactobacillus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University

Publications and helpful links

General 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2024
• Primary Completion (Actual): January 6, 2026
• Study Completion (Actual): January 6, 2026

Study Registration Dates

• First Submitted: June 20, 2024
• First Submitted That Met QC Criteria: June 20, 2024
• First Posted (Actual): June 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic; Eczema; Dermatologic Agents; Therapeutics; Lacteol
• Other Study ID Numbers: ADskincare2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No