Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:15 PM
Ignite Modification Date:
2025-12-24 @ 5:15 PM
NCT ID:
NCT01387750
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01387750
Study Brief:
Protocol Section:
NCT01387750