The offer in our phase 1 study center in Hamburg refers in particular to studies to prove an antimicrobial effect of products that are applied to the uninjured skin or mucous membrane as well as to studies on the skin microbiome and its change through the application of products. Endpoints can be the total microbial count or the change in previously artificially applied organisms through to microbiome research. Are your products “microbiome friendly”? If not, perhaps it's time.

We have been carrying out tests for over 20 years, particularly on the efficacy of hand disinfectants and skin antiseptics in accordance with standard norms. With Ralf Freese, we have now brought an investigator and Dr. Saskia Borregaard, a GCP expert for the regulatory framework, into the team. Both have over 15 years of experience in planning, conducting and evaluating clinical trials.

This enables us to offer everything from a single source for medical device and drug studies at GCP (Good Clinical Practice) level with an up-to-date SOP system, from the idea, study design with meaningful, helpful and realistic microbiological endpoints by our expert Dr. Florian H. H. Brill, writing the study protocol, submission to the ethics committee, recruitment and education of subjects, conducting the study, sampling of subjects, microbiological evaluation and reporting.

If you are interested in participating in the studies as a volunteer, please contact us HERE.

We are also open to partial steps in which our clinical-microbiological experience is helpful for you. We are available for consultation in the context of study design or as a microbiology laboratory to take over the evaluation of samples in the context of clinical trials at other study centers and, for example, to provide sampling kits. We are of course also available as a study center including a microbiology laboratory if you can and want to map the regulatory part differently.

On request, we can take over the complete organization from the idea, through the design and submission to the ethics committee, the execution of the study to the evaluation and interpretation of the data. Of course, we are also happy to offer microbiological services in the context of clinical studies at other study centers.

We look forward to receiving your inquiries, which will be dealt with personally by Dr. Florian H. H. Brill and his team.

The microbiome is a representation of all microorganisms in a system under consideration. Gain insight into the species richness and population structure of a sample. Identify marker organisms or complex networks indicative of a typical state of the microbiome. We perform microbiome analyses including bioinformatic evaluation for bacteria and archaea based on the 16S rRNA gene. By means of quantitative PCR  the relative abundances can also be related to the total cell number.

The skin microbiome is central to maintaining healthy and resilient skin. Environmental influences and diseases can lead to significant changes in the microbiome. Pro- or prebiotic cosmetics and pharmaceuticals can be used to target changes in the skin microbiome. 

Changes in the microbiome can be tracked at high resolution using the next-generation sequencing (NGS) techniques. In this way, the influence of cosmetic applications on the microbiome can be shown over time and or in a dose-dependent manner.