A Prospective Randomized Double-Blinded Placebo Controlled, Explorative Phase I Trial to Investigate the Safety and Tolerability of Two Different Doses of Topically Administered APOSEC™ in Healthy Male Subjects With Artificial Dermal Wounds

"On day 0, a blinded and randomized test treatment with Verum and Placebo is performed on intact skin. If the subject does not reveal any adverse events, the actual treatment phase is initiated 24h later.~Following baseline evaluation on day 1, two punch biopsies (4mm) on the inner upper side of the non-dominant arm are set under local anesthesia. One wound on the upper arm (proximal or distal) will be treated with placebo and the second wound will be treated with the allocated concentration of Verum according to previous randomization scheme set for test treatment. Approximately 1ml of Verum vs. placebo will be applied on the artificial wounds.~From day 2 to 6, artificial wounds will be cleaned with 0.9 % NaCl and then allocated treatment will be administered. Wound dressing will be done daily and will cover the whole area of application.~On day 7 the treatment is terminated and the wound is evaluated with respect the extension of wound closure."