Effects of Topical Cream for Pain Relief | NCT05213052

Studies
Effects of Topical Cream for Pain Relief

NCT05213052

Sponsor

Natural Immune Systems Inc

Status

Completed

Last Update Posted

Jun 9, 2022Actual

Enrollment

12Actual

Phase

Not Applicable

Conditions

Chronic Pain

Interventions

Topical cream

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2021Actual

Primary Completion Date

Feb 1, 2022Actual

Completion Date

May 1, 2022Actual

First Submitted Date

Aug 31, 2021

First Submission Date that Met QC Criteria

Jan 16, 2022

First Posted Date

Jan 28, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 7, 2022

Last Update Posted Date

Jun 9, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Topical cream	Other	Topical cream applied to painful joint or muscle	Topical cream, 1 - 2 times daily

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in degree of pain	Pain questionnaire - yes/no, score 0-24 hours	4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Activity level	Activities of daily living questionnaire	4 weeks

Other Outcomes

Measure	Description	Time Frame
Wellness	Wellness questionnaire - Score 0-10 [0 being strongly disagree, 10 being strongly agree]	4 weeks

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gitte Jensen		Klamath Falls	Oregon	97601-5904	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D059350	Chronic Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C585595	Floderm topical cream

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided