NCT05755256

The Impact of Probiotics on Skin Hydration in Youth with Mild Acne

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Lallemand Health Solutions · Industry
• Sex: All
• Age: 15 Months – 26 Years
• Healthy volunteers: Accepted

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.

Conditions

• Acne Vulgaris
• Hydration Acne

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	After randomization, participants will consume the probiotic for 12 weeks.
DIETARY_SUPPLEMENT	Placebo	After randomization, participants will consume the placebo for 12 weeks.

Timeline

• Start date: 2023-09-04
• Primary completion: 2024-09-18
• Completion: 2024-09-18
• First posted: 2023-03-06
• Last updated: 2024-09-20

Locations

1 site across 1 country: France