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

Inclusion Criteria:

• Healthy male & females; 35 to 75 years of age with signs of facial aging.

• Fitzpatrick I-VI phototype skin types.

• Volunteers with wrinkle grading of 1 to 4 according to Lemperle (2001) wrinklegrading scale.

• Volunteers with a laxity grading of 1-3.5 according to Alexiandes Armenakas (2010)grading scale.

• Written informed consent is given.

• Females of childbearing potential (FOCBP) and females who are premenses must bewilling to practice effective contraception for the duration of the study. (Effective contraception is defined as stabilized on oral contraceptive for at least 3 months, intrauterine device, condom with spermicide, diaphragm with spermicide,implant, NuvaRing, injection, transdermal patch or abstinence.)

• Females on birth control pills must have taken the same type of pill for at least 3months prior to entering the study and must not change type during the study.

• Those who have used birth control pills in the past must have discontinued usage atleast 3 months prior to the start of the study.

• Volunteers agree NOT to use any topical agents containing active ingredients such asretinol, glycolic acid in the treatment area, during the study period.

• Volunteers agree NOT to undergo any aesthetic treatments (such as Botox, fillers,microdermabrasion, laser surfacing etc.) in the treatment area, during the studyperiod.

Exclusion Criteria:

• Volunteers have used a topical anti-aging product containing active ingredientswithin 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, orhigh doses of corticosteroids.

• Volunteers suffer from keloid scars, Human Papilloma virus (HPV) or birth marks inthe 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 6months.

• Volunteers have undergone filler injections in the treatment area within the last 6months.

• Volunteers have received Botox or other neuromodulators injections in the treatmentarea within the last 6 months.

• Females who are pregnant, breast-feeding or who wish to become pregnant during thestudy period.

• Enrolled in another clinical trial during the same study period.

• Volunteer has a planned hospital admission and/or surgical procedure for an illnessor disease which existed before enrolment into the clinical trial, and which mayinterfere with the course or outcome of the study.

• Volunteering has medical or psychological condition(s) associated with a risk ofpoor protocol compliance (e.g., alcoholism or drug abuse).

• Volunteer is undergoing or is likely to undergo other treatments.