Mentholated Cream Containing Oxygenated Glycerol Triesters on Acute Pain of the Muscles and Joints
Mentholated Cream Containing Oxygenated Glycerol Triesters on Acute Pain of the Muscles and Joints
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.
Inclusion Criteria:

 1. Were males and females between the ages of 18 and 75, in good general health (no
 physical required but subjects did fill out a medical history questionnaire)

 2. Were individuals free of any systemic or dermatological disorder including a known
 history of allergies or other medical conditions which, in the opinion of the
 investigator, might have interfered with the conduct of the study, interpretation of
 results or increased the risk of adverse reactions;

 3. Were individuals that had recently (< three months) started to suffer from acute
 musculoskeletal pain (i.e. arthritis, simple back pain, muscle strains);

 4. Agreed to stop any anti-inflammatory or analgesic medications two days prior to
 starting the study;

 5. Had the ability to complete the course of the study and to comply with instructions;

 6. Agreed not to use or introduce any new personal care products (including cosmetics,
 skin care, hand care, body care, hair care, personal hygiene, etc.) into their normal
 regimen during the course of the study;

 7. Agreed to avoid sun exposure during the course of the study;

 8. Were females that were surgically sterile, post-menopausal or using an acceptable
 method of birth control; and

 9. Were able to read, understand and provide written informed consent.

 Exclusion Criteria:

 1. Were individuals with any visible skin disease or skin condition (e.g., eczema), which
 might have interfered with the evaluations;

 2. Were individuals with excessive dryness or redness at the sites of application;

 3. Were individuals who suffered from chronic and/or severe musculoskeletal pain;

 4. Were individuals with a known hypersensitivity to topical analgesics or other pain
 relieving products;

 5. Were females who were pregnant, planning a pregnancy or nursing a child;

 6. Were individuals who were participating, or had participated, on a clinical study
 involving the body (exclusive of the face) within 28 days prior to study initiation;

 7. Were individuals who had psoriasis;

 8. Were individuals currently under treatment for asthma or diabetes (insulin-dependent
 only);

 9. Were individuals with active atopic dermatitis/eczema at the test sites;

 10. Were individuals taking prescription or over-the-counter anti-inflammatory
 medications, non- steroidal anti-inflammatory drugs and topical, oral and systemic
 steroids; and

 11. Were individuals with known allergies to any of the components of the test articles.