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

Completed · Phase 1 · Has a placebo group

Conditions studied: Pain

In brief

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.

Key facts

Study ID

NCT02169154

Run by

GlaxoSmithKline

People needed

36

Starts

2014-06-01

Expected to finish

2014-07-01

Last updated by the study team

2017-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• TKL Research Inc — Paramus, New Jersey, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.