A Safety Study to Investigate the Skin Sensitization Potential of MFC51123

• Status: Completed
• Trial end date: 2014-07-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Diclofenac; Menthol

Criteria

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.