Assessment of the Safety and Efficacy of 3VM1001 Cream for Treatment of Chronic Pain Caused by Knee Osteoarthritis.

Inclusion Criteria: * Osteoarthritis of the knee according to American College of Rheumatology clinical radiological criteria; * OA of knee ≥ 6 months prior to screening; * age 40 years or older; * subjects of childbearing potential and their partners must use effective contraception; * women of childbearing age must have a negative pregnancy test or screening or be using an acceptable form of birth control; * moderate to severe chronic OA pain defined as POM score between 40 mm and 90 mm; * baseline WOMAC pain subscale score ≥ 9; * no change in physical activity and/or therapy for the past 3 months;- all concurrent medications taken for any reason stable for 14 days; * ability to follow protocol with reference to cognitive and situational factors (eg. stable housing, ability to attend visits; * ability to read and write English; * ability to apply cream without assistance; * able to provide written informed consent. Exclusion Criteria: * Presence of significant medical disorder that would compromise the participant's safety to take part in the trial (e.g. cancer, immunosuppressed) or evidence of alcohol or substance abuse; * Wilson's disease or other disorder of copper metabolism * BMI \>35 * Known hypersensitivity or allergy to any component of the product, or to acetaminophen * Pregnant and breastfeeding women * Transcutaneous electrical nerve stimulation and use of crutches, walkers, or wheel chairs should be excluded prior to and during treatment * Active conditions over the area to be treated such as eczema or psoriasis, compromised integrity of the intact, superficial skin layer over the area to be treated. * Pain in any joint other than the index joint that could interfere with the patient's assessment of pain in the index joint * Recent injury (traumatic or sports related) to either knee causing pain and interference with daily activities (e.g. walking) * Recent surgery/procedure to either knee causing pain that could interfere with study assessments of pain, function, and QoL. * Extreme pain in the target knee characterized by POM score of \>90 mm * Mild pain in the target knee, characterized by POM score of \< 40 mm * Open surgery of the target knee within the last year * Arthroscopic surgery of the target knee within the last 3 months * Use of prohibited concomitant medications/therapies during the 30-day treatment period including: 1. devices or therapeutic treatments for knee pain or ambulation 2. analgesics other than acetaminophen 3. System…