Without exception, the new pharmaceutical drugs must first demonstrate their safety with healthy volunteers (Phase I). These first have to sign an informed consent document with information about the research. Moreover, for the safety trials, they are required not to have any toxic habits nor show any clinically significant alterations and undergo complete analyses, electrocardiograms, physical check-ups, etc.

At each of the mentioned hospitals (Pamplona and Madrid) 18 volunteers are to take part, divided into 3 groups of 6. The first group will receive a topical treatment with P144 and the others with a placebo (without active treatment). After a week of daily application without any relevant side effects, the 2nd group will be treated with a higher dose. Likewise, after assessing the state of the skin, the third group will receive treatment. In each group two people will receive the placebo and four the active treatment. In this manner, the research avoids exposing all the volunteers to the product until its safety has been assured step by step. The two hospitals will set up multidisciplinary teams of experts to supervise the trials: dermatologists, doctors in other specialities, nurses and pharmacologists, amongst others.

The treatment consists of the daily application of P144 or of the placebo in the upper back zone. Over a period of 21 consecutive days the volunteers attend hospital for check-ups, answering some simple questions and receiving application of the cream again. In order to ensure their health, they must visit the centre after a month from the end of the treatment. As a legal obligation, there is an insurance policy covering possible risks.

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