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:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2025-12-25 @ 1:15 AM
NCT ID:
NCT03811093
Eligibility Criteria:
Inclusion Criteria:
Any healthy individual.
Exclusion Criteria:
* If you are pregnant, trying to get pregnant or nursing laser light therapy should be received only after the end of these conditions. There is no evidence of harm to a an unborn baby however there have been no safety tests either, so for medical legal reasons we recommend never treating areas directly over a developing child.
* Individuals with hypertension, light sensitive epilepsy, cancer, heart disease, infectious skin disease, and severe varicose veins should not use this device.
* People suffering from infectious and acute disease such as a fever should not use this device.
* People who have hemorrhagic disease, vascular ruptures, skin inflammation, or any disease of the skin should not use this device.
* People who have immune system dysfunction such as Leukemia, Hemophilia, etc., and light sensitive persons should not use this device.
* Individuals with a history of melanoma, raised moles, suspicious lesions, keloid scar formation, or healing problems should not undergo laser light therapy.
* Individuals with active infections, open lesions, hives, herpetic lesions, cold sores, or tattoos and permanent make-up in the area of treatment should not undergo laser light therapy.
* People who have used isotretinoin (commonly known as Accutane), tetracycline, St. John's Wort, or any photo sensitizing drugs in the last year should not undergo laser light therapy.
* Individuals with autoimmune diseases such as Lupus, Scleroderma, or Vitiligo should not undergo laser light therapy.
* Individuals who have pacemakers or other electro-stimulation devices surgically implanted should not undergo laser light therapy.
* Any insulin dependent individual should consult their physician before undergoing laser light therapy.
* All individuals considered "vulnerable" such as children, pregnant women, nursing home residents or other institutionalized persons, students, employees, fetuses, prisoners, and persons with decisional incapacity.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03811093
Study Brief:
Protocol Section:
NCT03811093