Clinical Evaluation of Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis
Status:
Completed
Trial end date:
2020-09-22
Target enrollment:
Participant gender:
Summary
The efficacy and safety of Solver Pen (prototype number X92001704) is evaluated in this
randomized, open label, controlled, investigator-blinded, comparative clinical trial in 76
patients. Subjects are treated with either the test medical device (Solver Pen) or the
comparator (Loceryl, 5% amorolfine), respectively, for a period of 90 days. The primary
objective of the investigation is the increase of percentage of healthy surface on the great
toenail at study end versus baseline, as evaluated by a blinded investigator. Patients are
followed up for a period of 90 days, with visits at D0 (baseline), D30, D60 and D90,
respectively.