Effects of Topical Cream for Pain Relief

Not Applicable

Completed

• Conditions: Chronic Pain
• Interventions: Other: Topical cream

• Registration Number: NCT05213052
• Lead Sponsor: Natural Immune Systems Inc

Brief Summary

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

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 Timeline

• Study Start: 2021-08-01
• Study First Submitted: 2021-08-31
• Study First Submitted QC: 2022-01-16
• Study First Posted: 2022-01-28
• Primary Completion: 2022-02-01
• Status Verified: 2022-05
• Study Completion: 2022-05-01
• Last Update Submitted: 2022-06-07
• Last Update Posted: 2022-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Topical cream, 1 - 2 times daily	Topical cream	Application of a pea-sized amount of cream applied to skin over the area with chronic pain

Primary Outcome Measures

Name	Time	Method
Change in degree of pain	4 weeks	Pain questionnaire - yes/no, score 0-24 hours

Secondary Outcome Measures

Name	Time	Method
Activity level	4 weeks	Activities of daily living questionnaire

Trial Locations

Locations (1)

Gitte Jensen; 🇺🇸 Klamath Falls, Oregon, United States