Chronic PainNCT05213052
Effects of Topical Cream for Pain Relief
A study testing Topical cream in people with Chronic Pain, run by Natural Immune Systems Inc at 1 site in United States.
Trial summary
To perform a clinical proof-of-concept study on a novel topical formula for pain relief. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Topical cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Chronic Pain
- Being tested
- Topical cream
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical creamOther
Topical cream applied to painful joint or muscle
| Study group | Role | What they receive |
|---|---|---|
| Topical cream, 1 - 2 times daily | Experimental | Application of a pea-sized amount of cream applied to skin over the area with chronic pain Receives: Other: Topical cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in degree of pain
Pain questionnaire - yes/no, score 0-24 hours
Measured: 4 weeks
Secondary outcomes (1)
Activity level
Activities of daily living questionnaire
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start1 Aug 2021
- Primary completion1 Feb 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Natural Immune Systems Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213052
- Sponsor's protocol ID
- 173-001
- Status last verified
- May 2022
- First submitted
- 31 Aug 2021
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Document Magnitude and Timing for Pain Relief of Topical Cream
- ClinicalTrials.gov ID
- NCT05213052
- Acronym / sponsor ID
- 173-001
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Natural Immune Systems IncUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- An open-label study design where all study participants will receive the active test product and no placebo is used.
| Arm | Type | Receives |
|---|---|---|
| Topical cream, 1 - 2 times daily | Experimental | Other: Topical creamApplication of a pea-sized amount of cream applied to skin over the area with chronic pain |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical creamTopical cream applied to painful joint or muscle | Other | Topical cream, 1 - 2 times daily |
Primary outcome
Change in degree of pain
Time frame: 4 weeks
Pain questionnaire - yes/no, score 0-24 hours
1 secondary outcome
Activity level
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Chronic Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical cream in people with Chronic Pain, run by Natural Immune Systems Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in degree of pain (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.