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

NCT06474728 | Completed

• 1 other identifier: ADskincare2024
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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 conventional emollients.

Conditions

Atopic Dermatitis; Eczema; Emollient

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Interventions

Treatment with an Emollient Containing Postbiotic Saccharomyces and Lactobacillus OTHER

Treatment with an Emollient Containing Postbiotic Saccharomyces and Lactobacillus, with the dose of 100g per week,lasting for 12weeks.

Treatment with an Emollient Containing Postbiotic Saccharomyces and Lactobacillus

Eligibility Criteria

• Age: 1 Month - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Department of Dermatology,Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

Related Publications (1)

• 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.

  PMID: 31705602 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

Therapeutics; Lacteol

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: June 26, 2024
• Study Start: October 9, 2024
• Primary Completion: January 6, 2026
• Study Completion: January 6, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)