Mentholated Cream
OtherA topical cream containing menthol without the addition of the oxygenated glycerol triesters.
NCT Number: NCT01387750
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.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 1 / Phase 2
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A topical cream containing menthol without the addition of the oxygenated glycerol triesters.
A Topical Cream that contained both menthol and oxygenated glycerol triesters.
Patients were instructed to identify one area on their body where they were experiencing the most acute musculoskeletal pain/discomfort.
How limited patient activities were due to the pain associated with the area of interest.
Patient assessed how mobile their joints/muscles were within the area of interest.
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.
NEMA Research, Inc.
Industry
Evaluating the Efficacy, Tolerance and Acceptability of a Mentholated Cream Containing Oxygenated Glycerol Triesters (OGT) on Acute Pain in Subjects Suffering From a Recent Inflammation of the Muscles and/or Joints
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