Ignite Creation Date:
2024-07-17 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474728
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-20
Brief Title:
Effects of an Emollient Containing Postbiotic Saccharomyces and Lactobacillus on Pediatric Atopic Dermatitis
Sponsor:
Childrens Hospital of Fudan University
Organization:
Childrens Hospital of Fudan University
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Investigators 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 InfantChild Dermatology Quality of Life Index IDQOLCDQOL 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 skins acidity level
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 Investigators 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 InfantChild Dermatology Quality of Life Index IDQOLCDQOL 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 skins acidity level
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None