A Safety Study to Investigate the Skin Sensitization Potential of MFC51123
Status:
Completed
Trial end date:
2014-07-15
Target enrollment:
Participant gender:
Summary
This research study is being carried out to determine the possibility that a new medication
causes allergic reactions. This new medication contains two active ingredients (diclofenac
and menthol) together in a gel and is being developed to treat mild to moderate pain and
inflammation, such as acute sport injuries, and sprains and strains. Approximately 240
participants will have the medication (gel) applied to the skin on a small area of the upper
back for approximately 48-hour or 72-hour periods over the course of six weeks. Participation
in this research study is voluntary, requiring participants to visit the study clinic on 17
occasions for about 45 minutes each visit. During the visits, doctors or trained staff
members will examine the amount of redness, swelling, and other signs of irritation (if any)
of the skin where the medication (gel) was applied.