NCT04216160

Skin Acceptance and Efficacy Assessment of a Topical Product in Acne Treatment When Compared to a Placebo.

Skin Acceptance and Efficacy Assessment of a Topical Product in Acne Treatment When Compared to a Placebo, Under Normal Use Conditions.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: YUN NV · Industry
• Sex: All
• Age: 12 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
OTHER	ACN cream (YUN)	Application of the facial cream ACN (YUN) twice a day, for 8 weeks +/- 2 days. Assessment before product use (T0), after 2, 4 and 8 weeks +/- 2 days of product use (T2w, T4w and T8w, respectively) and after 4 weeks +/- 2 days without product use (T12w).
OTHER	Placebo cream (YUN)	Application of the facial placebo cream twice a day, for 8 weeks +/- 2 days. Assessment before product use (T0), after 2, 4 and 8 weeks +/- 2 days of product use (T2w, T4w and T8w, respectively) and after 4 weeks +/- 2 days without product use (T12w).

Timeline

• Start date: 2019-05-05
• Primary completion: 2019-11-28
• Completion: 2020-02-11
• First posted: 2020-01-02
• Last updated: 2021-05-17

Locations

1 site across 1 country: Brazil