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

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Diclofenac; Menthol

Criteria

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