Mentholated Cream Containing Oxygenated Glycerol Triesters on Acute Pain of the Muscles and Joints

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

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 Overview

• Status: Completed
• Conditions: Pain; Analgesics
• Intervention / Treatment: Other: Mentholated Cream; Other: Mentholated Cream with OGT

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Mentholated Cream	Other: Mentholated Cream; A topical cream containing menthol without the addition of the oxygenated glycerol triesters.
Active Comparator: Mentholated Cream with OGT	Other: Mentholated Cream with OGT; A Topical Cream that contained both menthol and oxygenated glycerol triesters.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description
Severity of Pain	Patients were instructed to identify one area on their body where they were experiencing the most acute musculoskeletal pain/discomfort.

Secondary Outcome Measures

Outcome Measure	Measure Description
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.

Collaborators and Investigators

• Sponsor: NEMA Research, Inc.
• Collaborators: Laboratories Carilene
• Investigators: Principal Investigator: Barry T Reece, MS, MBA, RCTS, Inc.; Study Director: Jessica Williams, BS, RCTS, Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): June 1, 2007
• Study Completion (Actual): June 1, 2007

Study Registration Dates

• First Submitted: June 30, 2011
• First Submitted That Met QC Criteria: July 5, 2011
• First Posted (Estimate): July 6, 2011

Study Record Updates

• Last Update Posted (Estimate): July 6, 2011
• Last Update Submitted That Met QC Criteria: July 5, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Musculoskeletal Pain; Acute Pain; Topical Analgesic
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: RCTS2223