Efficacy and Tolerability of SkinPen on Male and Female Subjects' Wrinkles of the 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 wrinkles Individuals willing to withhold aesthetic therapies to the areas of the neck being treated or judged to potentially impact results by the Investigator.

Women of childbearing 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 monthly 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 the 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 the study;
• Without a uterus and/or both ovaries;
• Bilateral tubal ligation at least 6 months prior to study enrollment.

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

• Established use of hormonal methods of contraception (oral, injected, implanted, patch, or vaginal ring).
• Barrier methods of contraception with spermicide: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
• Intrauterine device (IUD) or intrauterine system (IUS)
• Surgical sterilization (e.g., vasectomy that has been confirmed effective by sperm count check, tubal occlusion, hysterectomy, bilateral salpingectomy/oophorectomy)
• 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 skincare products.
• Individuals who have the 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 ( 5 ac