Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-01-01 @ 7:20 AM
Study NCT ID:
NCT04216160
Status:
COMPLETED
Last Update Posted:
2021-05-17
First Post:
2019-12-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Skin Acceptance and Efficacy Assessment of a Topical Product in Acne Treatment When Compared to a Placebo.
Sponsor:
YUN NV
Organization:
Study Overview
Official Title:
Skin Acceptance and Efficacy Assessment of a Topical Product in Acne Treatment When Compared to a Placebo, Under Normal Use Conditions.
Status:
COMPLETED
Status Verified Date:
2021-05
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:
In this study the topical use of cream with live probiotic bacteria was evaluated for its efficacy in reducing acne symptoms and its effect on the skin microbiota on patients with acne vulgaris. Patients with mild to moderate acne used the probiotic cream for 8 weeks and clinical evaluation and microbiological sampling was done at start, 2, 4, 8 and 12 weeks (after 4 weeks without use of the product). Next-Generation Sequencing is used to analyze the skin microbiota of the patients.
Detailed Description:
Probiotics are live micro-organisms which when administered in adequate amounts can exert a health benefit on the host. This health-promoting effects have been extensively studied in the gastrointestinal niche but it becomes more and more clear that other niches are also interesting for the potential of probiotics. Recent breakthroughs in 'next generation sequencing' (NGS) technologies are making it now possible to map the microbiota after DNA extraction, which is very interesting for bacteria that are not or difficult to cultivate. The research into the microbiota of the skin with such new NGS technologies shows that there is also an equilibrium in the skin composition of the microbiota and that there is a disturbance of the skin microbiota in acne. Acne vulgaris is known as a multifactorial condition, both hormonal triggers and environmental factors play a role. However, it is also known that Cutibacterium acnes and Staphylococcus spp. play an important role in the inflammation of the sebaceous gland follicles. Therefore, probiotic strains with antipathogenic activity against these bacteria and suitable for application to the skin are potentially able to restore the balance of the skin microbiota and reduce acne symptoms. The main objective of this study was to verify the skin acceptance and efficacy of the cream with live probiotic bacteria for acne treatment in comparison with a placebo. More specifically to evaluate the effect of the 'live' Lactobacillus species as 'active ingredient' in relation to acne symptoms and skin microbiome modulation.
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?:
None
Is an FDA AA801 Violation?: