A Safety Study to Investigate the Skin Sensitization Potential of MFC51123
Status: | Completed |
---|---|
Conditions: | Chronic Pain |
Therapuetic Areas: | Musculoskeletal |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 6/29/2017 |
Start Date: | April 1, 2014 |
End Date: | July 15, 2014 |
Safety Study to Investigate the Skin Sensitization Potential of MFC51123
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.
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.
Inclusion Criteria:
- Healthy men or women participants with 18 years of age or older.
Exclusion Criteria:
- Participants with a history of hypersensitivity, allergy with the use of NSAIDs or
menthol or currently receiving systemic or topical NSAIDs within 3 days of visit 1.
- Participants having psoriasis and/or active atopic dermatitis/eczema, and skin
infected.
- Lesions, burn or wound in the application site.
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