Efficacy and Tolerability of SkinPen on Male and Female Subjects' Fine Lines and Wrinkles of the Face and Neck

Inclusion Criteria:

- At least 20% of subjects will have Fitzpatrick skin types IV-VI

- Individuals who grade a 4 or higher on the Fitzpatrick Wrinkle Scale

- Individuals that desire correction of their fine lines and wrinkles

- Individuals willing to withhold aesthetic therapies to the areas of the face and neck
being treated or judged to potentially impact results by the Investigator.

- Women of child bearing potential agree to take a urine pregnancy test at the Baseline
visit and 6-months post-treatment or when deemed by Investigator and/or Sponsor. This
may be changed to one month pregnancy test at the Sponsor's discretion. Women who are
of childbearing potential must have a negative urine pregnancy test result and must
not be lactating at the baseline visit. Women must be willing and able to use an
acceptable method of birth control (e.g. barrier methods used with a spermicidal
agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study.
Women will not be considered of childbearing potential if one of the following
conditions is documented on the medical history:

- Postmenopausal for at least 12 months prior to study;

- Without a uterus and/or both ovaries;

- Bilateral tubal ligation at least 6 months prior to study enrollment.

- Women of child bearing potential agree to take a urine pregnancy test at the Baseline
visit and 6-months post-treatment or when deemed by Investigator and/or Sponsor. This
may be changed to one month pregnancy test at the Sponsor's discretion. Women who are
of childbearing potential must have a negative urine pregnancy test result and must
not be lactating at the baseline visit. Women must be willing and able to use an
acceptable method of birth control (e.g. barrier methods used with a spermicidal
agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study.
Women will not be considered of childbearing potential if one of the following
conditions is documented on the medical history:

- Postmenopausal for at least 12 months prior to study;

- Without a uterus and/or both ovaries;

- Bilateral tubal ligation at least 6 months prior to study enrollment.

- Individuals of child baring potential who use an acceptable method of contraception
throughout the study. Acceptable methods of birth control include:

1. Established use of hormonal methods of contraception (oral, injected, implanted,
patch or vaginal ring).

2. Barrier methods of contraception with spermicide: condom or occlusive cap
(diaphragm or cervical/vault caps) with spermicidal
foam/gel/film/cream/suppository.

3. Intrauterine device (IUD) or intrauterine system (IUS)

4. Surgical sterilization (e.g., vasectomy that has been confirmed effective by
sperm count check, tubal occlusion, hysterectomy, bilateral
salpingectomy/oophorectomy)

5. Abstinence from heterosexual intercourse, when this is in line with the preferred
and usual lifestyle of the subject. Periodic abstinence (e.g., calendar,
ovulation, symptothermal, post-ovulation methods) and withdrawal are not
acceptable methods of contraception.

- Individuals that are willing to provide written informed consent and are able to read,
speak, write, and understand English.

- Individuals willing to sign a photography release.

- Willingness to cooperate and participate by following study requirements (including
those outlined in section 5.5) for the duration of the study and to report any changes
in health status or medications, adverse event symptoms, or reactions immediately.

Exclusion Criteria:

- Individuals diagnosed with known allergies to facial or general skin care products.

- Individuals who have presence of an active systemic or local skin disease that may
affect wound healing.

- Individuals who have severe solar elastosis.

- Individuals with sensitivity to topical lidocaine.

- Individuals who have physical or psychological conditions unacceptable to the
Investigator.

- Individuals who have a recent history of significant trauma to the areas to be treated
(< 6 months).

- Individuals who have significant scarring, other than acne scars, in the area(s) to be
treated.

- Individuals who have severe or cystic active and clinically significant acne on the
area(s) to be treated. Clinically significant acne is defined as a subject whom has >
5 active inflammatory acne lesions (including acne conglobate, nodules, or cysts) in
either the right or left treatment area.

- Individuals who have a recent or current history of inflammatory skin disease,
infection, cancerous/pre-cancerous lesion, unhealed wound or clinically significant
acne in the proposed treatment areas. Individuals who have a history of systemic
granulomatous diseases, active or inactive, (e.g. Sarcoid, Wegeners, TB, etc.) or
connective tissue diseases (e.g. lupus, dermatomyositis, etc.).

- Individuals who currently have or have a history of hypertrophic scars, or keloid
scars.

- Individuals who currently have cancerous or pre-cancerous lesions in the areas to be
treated and/or with a history of skin cancer.

- Individuals who have the inability to understand instructions or to give informed
consent.

- Individuals who have had microdermabrasion or glycolic acid treatment to the treatment
area(s) within 1 month prior to study participation or who will have this treatment
during the study.

- Individuals who have a history of chronic drug or alcohol abuse.

- Individuals undergoing concurrent therapy that, in the Investigator's opinion, would
interfere with the evaluation of the safety or efficacy of the study device.

- Individuals who, in the Investigator's opinion, have a history of poor cooperation,
noncompliance with medical treatment, or unreliability.

- Individuals who are current smokers or have smoked in the last 5 years.

- Individuals who have a history of the following cosmetic treatments in the area(s) to
be treated:

- Skin tightening procedure within the past year;

- Injectable filler of any type within the past:

- 12 months for Hyaluronic acid fillers (e.g. Restylane)

- 12 months for Ca Hydroxyapatite fillers (e.g. Radiesse)

- 24 months for Poly-L-Lactic acid fillers (e.g. Sculptra)

- Ever for permanent fillers (e.g. Silicone, ArteFill)

- Neurotoxins within the past 3 months;

- Ablative resurfacing laser treatment;

- Non-ablative, rejuvenative laser or light treatment within the past 6 months;

- Surgical dermabrasion or deep facial peels;

- Had a chemical peel, dermabrasion, non-ablative laser or fractional laser
resurfacing of the face and neck within 4 weeks

- Individuals with a history of using the following prescription medications:

- Accutane or other systemic retinoids within the past 6 months;

- Topical Retinoids within the past 2 weeks;

- Prescription strength skin lightening devices (e.g. hydroquinone, tretinoin, AHA,
BHA and polyhydroxy acids, 4-hydroxyanisole alone or in combination with
tretinoin, etc.) within 4 months;

- Any anti-wrinkle, skin lightening devices, or any other device or topical or
systemic medication known to affect skin aging or dyschromia (devices containing
alpha/beta/poly-hydroxy acids, vitamin C, soy, Q-10, hydroquinone; systemic or
licorice extract (topically), Tego® Cosmo C250, gigawhite, lemon juice extract
(topically), emblica extract, etc.) within 2 weeks;

- Antiplatelet agents/Anticoagulants (Coumadin, Heparin, Plavix, chronic NSAID
use); and/or

- Psychiatric drugs that in the Investigator's opinion would impair the subject
from understanding the protocol requirements or understanding and signing the
informed consent.

- Individuals who are nursing, pregnant, or planning to become pregnant during the study
according to subject self-report.

- Individuals having a health condition and/or pre-existing or dormant dermatologic
disease on the face or body (e.g., psoriasis, rosacea, eczema, seborrheic dermatitis,
vitiligo, hyper or hypo-skin pigmentation conditions such as post inflammatory
hyperpigmentation) that the Investigator or designee deems inappropriate for
participation or could interfere with the outcome of the study.

- Individuals with a history of immunosuppression/immune deficiency disorders (including
HIV infection or AIDS) or currently using immunosuppressive medications (e.g.,
azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate
mofetil, methotrexate, prednisone, Remicade, Stelara.) and/or radiation as determined
by study documentation.

- Individuals with an uncontrolled disease such as asthma, diabetes, hyperthyroidism,
medically significant hypertension or hypothyroidism. Individuals having multiple
health conditions may be excluded from participation even if the conditions are
controlled by diet, medication, etc.

- Individuals with any planned surgeries, overnight hospitalization, and/or invasive
medical procedures during the course of the study.

- Individuals who are currently participating in any other study involving the use of
investigational devices or drugs or have participated in any clinical trial at UT
Southwestern or at another research facility or doctor's office within 4 weeks prior
to inclusion into the study.

- Individuals who have observable suntan, nevi, excessive hair, etc. or other dermal
conditions on the face and neck that might influence the test results in the opinion
of the Investigator or designee.

- Individuals who have any condition, which in the opinion of the Investigator makes the
patient unable to complete the study per protocol (e.g. patients not likely to avoid
other facial cosmetic treatments; patients not likely to stay in the study for its
duration because of other commitments, concomitant conditions, or past history;
patients anticipated to be unreliable, or patients who have a concomitant condition
that may develop symptoms that might confuse or confound study treatments or
assessments).

- Individuals who started hormone replacement therapies (HRT) or hormones for birth
control less than 3 months prior to study entry or who plan on starting, stopping, or
changing doses of HRT or hormones for birth control during the study.