Robust clinical assessment of skin microbiome or microbiota for cosmetics or personal care products, including participant recruitment, study design and clinical investigations

With increasing consumer and industry awareness of skin microbiome and the role it plays in maintaining skin health, innovation and exploration of the effect of cosmetics or personal care products on cutaneous microbiota have become a growing focus area. The application of topical products to the skin or scalp can have a positive or negative effect on the ecosystem of the cutaneous microflora and so it is important to better understand the impact of cosmetics, personal care products or other healthcare products such as medical devices.

By improving understanding through robust clinical studies, the resulting insight can help you to develop products that either avoid unbalancing the skin microbiome or, conversely, to rebalance a state of dysbiosis (also called dysbacteriosis) which is a microbial imbalance that can potentially lead to unwanted skin conditions (acne, atopy, dandruff).

Our Skin Microbiome Clinical Study Expertise

The Intertek Clinical Research team have unique experience in skin microbiome studies. Our dermatology experts have designed and conducted many studies on healthy volunteers or with volunteers suffering from a skin pathology. These studies have allowed our clients to understand the potential impact of their innovative new products on skin microbiota.

We offer 3 levels of investigation depending on the aim of the study:

1. Does the product modify / not modify the ratio of the majority species of bacteria? 
Technique used: Quantitative PCR to quantify 5 species of bacteria (known and targeted according to the sampling area)

2. Does the product have an impact / has no impact on the semi-quantitative composition and microbial diversity?  Technique used: Metagenomics - 16S rDNA sequencing of bacteria

3. Does the product have an effect / has no effect on certain functions and metabolic pathways of the microbiota and skin? Is there a possibility of correlating phenomena at the microbiota and skin level simultaneously? Technique used: High-resolution proteomics

Intertek performs the sampling for these studies according to good sampling practices already tested by a recognized expert partner in the field who will then take care of the analysis and interpretation of the results.

The Intertek Advantage

Our clinical studies are conducted to GCP standards and generate robust evidence-based insight to evaluate the safety and cosmetic aesthetic performance. Located in Paris, France, our location is well suited to volunteer recruitment and maintain one of Europe’s largest characterised databases of over pre-qualified volunteers to facilitate prompt recruitment.

Our clinical study project managers, clinical research assistants and clinical technicians have more than 20 years of experience. Our study design and methodology are always assessed by ethical panel approval and performed in accordance with the governing principles of the Helsinki Declaration and the relevant local regulations. 

We are experts in study design and our approach allows us to optimise robust and relevant data-driven insight for our clients through efficient protocol design, precise study implementation and efficient participant recruitment. 

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Cosmetics and Personal Care Clinical Testing

We regularly work with brand leaders within the cosmetics and personal care industry providing data for claim support and marketing across oral care, skin care, hair and scalp care. Our team can provide a full service including protocol development and ethics submissions, project management, data management, statistical analyses and report writing.