Effects of an Emollient Containing Postbiotic Saccharomyces and Lactobacillus on Pediatric Atopic Dermatitis
NCT ID: NCT06474728
Last Updated: 2025-02-14
Study Results
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Basic Information
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RECRUITING
NA
98 participants
INTERVENTIONAL
2024-10-09
2025-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment with an Emollient Containing Postbiotic Saccharomyces and Lactobacillus
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.
Treatment without an Emollient Containing Postbiotic Saccharomyces and Lactobacillus
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
1 Month
6 Years
ALL
No
Sponsors
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Children's Hospital of Fudan University
OTHER
Responsible Party
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Locations
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Department of Dermatology,Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Role: primary
References
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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.
Related Links
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Related Info
Other Identifiers
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ADskincare2024
Identifier Type: -
Identifier Source: org_study_id
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