Effects of Topical Cream for Pain Relief

NCT05213052 | Completed

• 1 other identifier: 173-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Change in degree of pain

  Pain questionnaire - yes/no, score 0-24 hours

  4 weeks

Secondary Outcomes (1)

• Activity level

  4 weeks

Other Outcomes (1)

• Wellness

  4 weeks

Study Arms (1)

Topical cream, 1 - 2 times daily

EXPERIMENTAL

Application of a pea-sized amount of cream applied to skin over the area with chronic pain

Other: Topical cream

Interventions

Topical cream OTHER

Topical cream applied to painful joint or muscle

Topical cream, 1 - 2 times daily

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Natural Immune Systems Inc: lead

Study Sites (1)

Gitte Jensen

Klamath Falls, Oregon, 97601-5904, United States

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Floderm topical cream

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: An open-label study design where all study participants will receive the active test product and no placebo is used.

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: January 28, 2022
• Study Start: August 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: May 1, 2022
• Last Updated: June 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)