Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT07260656
Eligibility Criteria:
Inclusion Criteria:
* At least 3 toes per foot
* Have otherwise intact feet.
* Absence of any eczema, hyperkeratosis, scleroderma, or other dermatological conditions afflicting the area of Test Article administration that may interfere with absorption, particularly hyperhidrosis.
* Must agree to apply the Test Article to painful areas of feet as directed by research personnel.
* Must agree to apply the Test Article to feet as instructed 2x per day.
* Must wait 60 minutes after each application of Test Article before filling out NRS forms.
* Unless burning is encountered soon after application, the participant must wait at least 60 minutes before washing feet after application of Test Article.
* All participants must be willing to use Test Articles blinded.
Exclusion Criteria:
* Younger than 25 and older than 75 years of age
* Any dermatological condition(s) with the potential to disrupt skin integrity or alter sensory function of the feet.
* Any open wounds, skin ulceration, infection, skin irritation (e.g., poison oak), history of eczema, trauma or burn (including sunburn) affecting the feet within 30 days.
* Any recent medical history of surgery affecting the feet.
* Unless part of a stable continuum of substance use prior to start of study, the use of any topical medication products on feet, including holistic formulations, patch or herbal products, cannabinoid products, prescription or over the-counter (OTC) analgesic creams/lotions/patches/gels, nonsteroidal anti-inflammatory drugs, acetaminophen, counterirritants, local anesthetics, or steroids is prohibited.
* Current substance abuse.
* History of hypersensitivity or allergy to chili peppers, coconut oil, Shea butter, or sunflower seed oil.
* Except for interventions for mobility, (e.g., physical therapy, exercise, grounding) no concurrent foot therapy for pain that may interfere with NRS evaluations is permitted (e.g., massage, electrophoresis, red light, etc.).
* No concurrent enrollment in another clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
75 Years
Study:
NCT07260656
Study Brief:
Protocol Section:
NCT07260656