A Safety Study to Investigate the Skin Irritancy Potential of Diclofenac-Menthol Gel

A Cumulative Skin Irritation Study Investigating the Skin Irritancy Potential of MFC51123 Diclofenac-Menthol Gel

This research study is being conducted to investigate the skin irritancy potential of a new medication which contains two active ingredients (diclofenac and menthol) together in a gel formulation and is being developed to treat mild to moderate pain and inflammation, such as acute sport injuries, sprains and strains.

Approximately 36 healthy subject volunteers will be exposed to seven test products (study treatment gel and six control products) simultaneously for 21 consecutive days. The seven test products will be applied using a 7-channel patch assembly that will be affixed to the infrascapular areas of the back of each subject for approximately 24 hours daily.

The subject will return to the clinic to undergo a skin irritation assessment at approximately 24 hours after the time the patch assembly was initially affixed.

During the visits, doctors or trained staff members will examine the signs of irritation (if any) of the skin where the test products are applied. The skin irritation assessment will primarily characterize the test products individually in terms of symptomatology using a 7-point categorical scale ranging from 1 (glazing and/or wrinkling) to 7 (erosion and/or vesiculation).

Inclusion Criteria:

• Male/female volunteer ≥18 years
• No systemic/dermatologic disorder

Exclusion Criteria:

• Visible skin disease at the site of application that might interfere with skin assessments
• Allergy or hypersensitivity to NSAIDs or menthol or any of the excipients in the test product
• History of physical or psychiatric illness, or medical disorder
• Recent history of alcohol or drug abuse
• Pregnant or lactating females