Effects of Topical Cream for Pain Relief

Document Magnitude and Timing for Pain Relief of Topical Cream

To perform a clinical proof-of-concept study on a novel topical formula for pain relief.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Other: Topical cream

Detailed Description

An open-label study where each participant will be involved in the study for 4 weeks. During the study participants will use the topical cream 1-2 times daily on the anatomical area(s) causing the most pain.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Klamath Falls, Oregon, United States, 97601-5904
      • Gitte Jensen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• BMI between 18.5 and 34.9 kg/m2 (inclusive)
• Chronic joint/muscle related pain for at least past 6 months
• Experiencing chronic pain in at least one specific anatomical area for more than 6 months.

Exclusion Criteria:

• Cancer during past 12 months
• Chemotherapy during past 12 months
• Currently taking prescription pain medications
• Getting regular joint injections (such as cortisone shots);
• Immunization during last month
• Participation in another clinical trial study during this trial, involving an investigational product or lifestyle change
• Regularly experiencing headaches, including migraines
• Serious active illness within past 6 months
• Significant active uncontrolled illness (such as lymphoma, liver disease, kidney failure, heart failure).
• Skin allergies related to ingredients in test product.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Topical cream, 1 - 2 times daily; Application of a pea-sized amount of cream applied to skin over the area with chronic pain	Other: Topical cream; Topical cream applied to painful joint or muscle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in degree of pain	Pain questionnaire - yes/no, score 0-24 hours	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activity level	Activities of daily living questionnaire	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wellness	Wellness questionnaire - Score 0-10 [0 being strongly disagree, 10 being strongly agree]	4 weeks

Collaborators and Investigators

• Sponsor: Natural Immune Systems Inc

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): February 1, 2022
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: August 31, 2021
• First Submitted That Met QC Criteria: January 16, 2022
• First Posted (Actual): January 28, 2022

Study Record Updates

• Last Update Posted (Actual): June 9, 2022
• Last Update Submitted That Met QC Criteria: June 7, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 173-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No