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CompletedNCT05213052Updated Jun 9, 2022

Effects of Topical Cream for Pain Relief

An interventional study of Topical cream in Chronic Pain, sponsored by Natural Immune Systems Inc. Completed at 1 site in United States. Open to participants aged 21 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-09.

Sponsored by Natural Immune Systems Inc · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
21 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Chronic Pain

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03

In context

Chronic Pain

2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.

This study's enrollment of 12 is below the median of 60 across 2,161 interventional studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

Natural Immune Systems Inc is the lead sponsor of 25 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • 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

Interventions

  • OtherTopical cream

    Topical cream applied to painful joint or muscle

06

What researchers measure

Primary outcomes

  1. Change in degree of pain

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

    Time frame: 4 weeks

Secondary outcomes

  1. Activity level

    Activities of daily living questionnaire

    Time frame: 4 weeks

Other outcomes

  1. Wellness

    Wellness questionnaire - Score 0-10 \[0 being strongly disagree, 10 being strongly agree\]

    Time frame: 4 weeks

07

Study locations

1 site
  • Gitte Jensen
    Klamath Falls, Oregon 97601-5904, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05213052
Lead sponsor
Natural Immune Systems Inc
Responsible party
Sponsor
First posted
Jan 28, 2022
Start date
Aug 1, 2021
Primary completion
Feb 1, 2022
Completion
May 1, 2022
Last update
Jun 9, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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