A single center trial to evaluate the efficacy, tolerance, and acceptability of Oxygenated Glycerol Triesters (OGT) mentholated cream on acute musculoskeletal pain in normal healthy adult volunteers suffering from a recent inflammation of muscles and joints. Patient who met eligibility requirements were instructed to identify one area on their body where they were experiencing the most acute musculoskeletal pain/discomfort. Patients were provided with visual analog scales in order to quantify their pain. Patients either received mentholated cream with or without OGT and instructed to rub on the identified site 3 times a day for 7 days. Pain and other observations were written in a diary for each day.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
71
A topical cream containing menthol without the addition of the oxygenated glycerol triesters.
A Topical Cream that contained both menthol and oxygenated glycerol triesters.
Severity of Pain
Patients were instructed to identify one area on their body where they were experiencing the most acute musculoskeletal pain/discomfort.
Limitation of Activity
How limited patient activities were due to the pain associated with the area of interest.
Evaluation of the mobility of the painful joint/muscle
Patient assessed how mobile their joints/muscles were within the area of interest.
Skin Toxicity
Tolerability was assessed from Redness and Dryness VAS recorded by the clinical evaluator. No formal safety testing was performed in this study; however anecdotal information (stinging, burning, itching, etc.) was captured on the subjects' diaries.
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