Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:01 PM
Study NCT ID:
NCT05755256
Status:
COMPLETED
Last Update Posted:
2024-09-20
First Post:
2023-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of Probiotics on Skin Hydration in Youth with Mild Acne
Sponsor:
Lallemand Health Solutions
Organization:
Study Overview
Official Title:
Randomized, Double-blind, Placebo-controlled Trial to Assess the Impact of Probiotics on Skin Hydration in Adolescents and Young Adults with Mild Acne Vulgaris.
Status:
COMPLETED
Status Verified Date:
2024-07
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:
YSH
Brief Summary:
The goal of this clinical trials is to test the impact of probiotics on skin hydration in adolescents and young adults with mild acne. The hypothesis of this study is that the probiotic formulation is superior to placebo in improving the skin hydration in adolescents and young adults with minimal acne after 12 weeks of consumption.
Detailed Description:
This pilot study is a monocentric, randomized, double-blind, placebo-controlled, parallel-arm study. The product allocation will be performed using a dynamic randomization algorithm designed to minimize imbalance between the 2 arms, within the strata defined by 3 factors: age, Global Acne Evaluation (GEA) score and sex.
60 participants (adolescents and adults) with mild acne vulgaris will be recruited for this study, according to the following inclusion and exclusion criteria.
There will be a total of 3 study visits: V1 (screening and randomization), V2 (mid-study follow-up), and V3 (end-of-study). The study will last a total of 12 weeks.
60 participants (adolescents and adults) with mild acne vulgaris will be recruited for this study, according to the following inclusion and exclusion criteria.
There will be a total of 3 study visits: V1 (screening and randomization), V2 (mid-study follow-up), and V3 (end-of-study). The study will last a total of 12 weeks.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: