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Effects of Topical Cream for Pain Relief

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Topical cream
Sponsored by
Natural Immune Systems Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Pain

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Gitte Jensen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Topical cream, 1 - 2 times daily

Arm Description

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

Outcomes

Primary Outcome Measures

Change in degree of pain
Pain questionnaire - yes/no, score 0-24 hours

Secondary Outcome Measures

Activity level
Activities of daily living questionnaire

Full Information

First Posted
August 31, 2021
Last Updated
June 7, 2022
Sponsor
Natural Immune Systems Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05213052
Brief Title
Effects of Topical Cream for Pain Relief
Official Title
Document Magnitude and Timing for Pain Relief of Topical Cream
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Natural Immune Systems Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
An open-label study design where all study participants will receive the active test product and no placebo is used.
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Topical cream, 1 - 2 times daily
Arm Type
Experimental
Arm Description
Application of a pea-sized amount of cream applied to skin over the area with chronic pain
Intervention Type
Other
Intervention Name(s)
Topical cream
Intervention Description
Topical cream applied to painful joint or muscle
Primary Outcome Measure Information:
Title
Change in degree of pain
Description
Pain questionnaire - yes/no, score 0-24 hours
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Activity level
Description
Activities of daily living questionnaire
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Wellness
Description
Wellness questionnaire - Score 0-10 [0 being strongly disagree, 10 being strongly agree]
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Gitte Jensen
City
Klamath Falls
State/Province
Oregon
ZIP/Postal Code
97601-5904
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Topical Cream for Pain Relief

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