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 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 1:12 AM
NCT ID:
NCT04219293
Eligibility Criteria:
Inclusion Criteria:
* Healthy males and females ages 30-60 years old.
* No previous minimally invasive or invasive skin resurfacing within the prior 12 months (i.e. fractionated laser, ablated laser, chemical peels, microneedling, etc…
* VisiaTM Scan showing aging including skin texture, wrinkles, brown spots, and pores.
* Patient willing to sign informed consent.
Exclusion Criteria:
* Keloid scars;
* History of eczema in treatment area; psoriasis and any other chronic skin conditions the Investigator determines disqualifies the patient for participation in treatment area;
* History of actinic (solar) keratosis in treatment area;
* History of hemophilia;
* History of diabetes;
* The presence of raised moles, warts on the targeted area.
* Absolute contraindications include; scleroderma, collagen vascular diseases or cardiac abnormalities; blood clotting problems; active bacterial or fungal infection; facial melanosis; malignant tumors, immunosuppression; use of blood thinners or prednisone; pregnant or nursing women; corticosteroids within two weeks of the procedure, chronic liver disease, porphyria or other skin diseases.
* Patient not willing to sign informed consent.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
60 Years
Study:
NCT04219293
Study Brief:
Protocol Section:
NCT04219293