Consent & Agreement
Before our study starts we guarantee complete transparency and full written informed consent on our participants. This step is closely surveilled by the Ethics Committee
Study Steps
Our study participants usually are followed through several steps:
Complete Check-up
During screening procedure all of our participants receive a careful medical examination including clinical laboratory
Medication (double-blind)
We apply the medication to be tested in usually 3 groups, either oral, topic or intravenous. Often single-dose applications are done within 3 to 5 possible groups: placebo, 3-dosages and reference medication
EEG & Laser-stimulation
During this condition our aim is to objectively and quantitatively measure the pain perception centrally by EEG. The perceived pain induced by a CO2 Laser is comparable to a pin prick
Electrocardiography (ECG)
A possible additional medical examination could contain ECG application
Analog scaling
During trial the participants are asked to fill in visual analogue scales (100mm) to obtain additional subjective data on the perceived pain after the laser sessions
Data Collection
While undergoing the several study conditions we will gather all data highly secured and according to the data protection regulations
"Wash-out" Phase
Between medication periods there is usually a week without medication application to “wash out” the compound from the body.
End of study check-up
To make sure you are going to leave the study in good health condition we will conduct a final complete medical check-up by the end of study
Data analysis
For our contracting clients we are delivering data top line analysis about only 2 weeks after termination of the experimental trial part of course under strict confidentiality
We care about you
In case of any incidents, questions or help is needed you can count on us. Even after the trial we will take care of any possible trial related events concerning your health
