Evaluation of Efficacy and Safety of the Skinstylus Sterilock Microneedling System for the Treatment of Facial Wrinkles

Exclusion Criteria

• •Volunteers have used a topical anti-aging product containing active ingredients within 4 weeks of commencing the study.
• •Volunteers suffer from Hemophilia or other clotting/bleeding disorders.
• •Volunteers taking anticoagulant therapy, e.g., warfarin, heparin.
• •Volunteers who have used aspirin continuously in the last 2 weeks.
• •Volunteers with active acne vulgaris of the face.
• •Volunteers who have stopped taking birth control pills within the last 3 months.
• •Volunteers suffer from uncontrolled diabetes mellitus.
• •Volunteers with known malignancy and/or undergoing chemotherapy, radiotherapy, or high doses of corticosteroids.
• •Volunteers suffer from keloid scars, Human Papilloma virus (HPV) or birth marks in the treatment area.
• •Volunteers have a tendency for keloid scar formation.
• •Volunteers suffer from eczema or skin rashes in the treatment area.
• •Volunteers suffer from systemic infections such as hepatitis.
• •Volunteers have known allergy to topical/local anesthetics.
• •Volunteers have continuously used high dose NSAIDs for the last 2 weeks.
• •Volunteers have undergone plastic surgery in the treatment area within the last 6 months.
• •Volunteers have undergone filler injections in the treatment area within the last 6 months.
• •Volunteers have received Botox or other neuromodulators injections in the treatment area within the last 6 months.
• •Females who are pregnant, breast-feeding or who wish to become pregnant during the study period.
• •Enrolled in another clinical trial during the same study period.
• •Volunteer has a planned hospital admission and/or surgical procedure for an illness or disease which existed before enrolment into the clinical trial, and which may interfere with the course or outcome of the study.
• •Volunteering has medical or psychological condition(s) associated with a risk of poor protocol compliance (e.g., alcoholism or drug abuse).
• •Volunteer is undergoing or is likely to undergo other treatments.