Skin Acceptance and Efficacy Assessment of a Topical Product in Acne Treatment When Compared to a Placebo.
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional

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.
    

Intervention name(s): ACN cream (YUN); Placebo cream (YUN)
Intervention type(s): Other; Other
Intervention description(s): 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).; 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).
Other intervention name(s): Topical cream with live probiotic bacteria
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment