SkinPen Efficacy on Acne Scars on the Face and/or Back

A Single-Center Trial to Evaluate the Efficacy and Tolerability of SkinPen on Male and Female Subjects' Acne Scars on the Face and/or Back

This single-center, clinical trial will take place over a 90 day course followed by 1-month and 6-month post treatment visits to assess the efficacy and tolerability of the SkinPen device when used on both men and women on the face and/or back.

At least 20 subjects of varying Fitzpatrick skin types will be admitted to the trial for treatment on their moderate to severe acne scars on the face and/or back. Implementation of needle depths ranging from 0.25 mm to 2.0 mm will depend on severity of scars and their location. Each subject will undergo 3 treatments in 30 day increments and will take pre-treatment images as well as 1-month and 6-months post treatment images. Assessment will be based on the Goodman and Baron's grading system, the Clinician's Global Aesthetic Improvement Scale, as well as a self-assessment.

Inclusion Criteria:

• Men and women 18 to 60 years of age.
• Subjects in good health.
• Approximately 5 to 10 atrophic acne scars of mixed types (boxcar and/or rolling scars with some icepick scars allowed) on face and/or back that are moderate to severe.
• Desire correction of his/her acne scarring.
• Subjects of child bearing potential must take a urine pregnancy test and must test negative.
• Subjects willing to sign a photography release.
• Willingness to cooperate and participate by following study requirements.

Exclusion Criteria:

• Allergies to facial or general skin care products
• Presence of an active systemic or local skin disease.
• Severe solar elastosis.
• Sensitivity to topical lidocaine.
• Recent history of significant trauma to the face (< 6 months).
• Significant scarring other than acne scars in treated area(s).
• Severe of cystic active and clinically significant acne on the area(s) to be treated.
• History of systemic granulomatous diseases.
• History of hypertrophic or keloid scars.
• Current cancerous or pre-cancerous lesions in area(s) to be treated.
• Had microdermabrasion or glycolic acid treatment to treatment area(s) within 1 month prior to study participation.
• History of chronic drug or alcohol abuse.
• Current smokers or have smoked in the last 5 years.
• History of cosmetic treatments: Skin tightening within last year, injectable filler of any type within the last year, neurotoxins within the last 3 months, ablative resurfacing laser treatments, non-ablative, rejuvanative laser treatments in last 6 months, chemical peel, dermabrasion, non-ablative laser or fractional laser resurfacing of face and neck within the last 4 weeks.
• History of certain prescription medications (accutane or other retinoids, topical retinoids, prescription strength skin lightening devices, anti-wrinkle, skin lightening devices, antiplatelet agents/Anticoagulants, and/or psychiatric drugs).
• Nursing, pregnant, or planning to become pregnant during study.
• Current or pre-existing dermatologic diseases on the face or body (psoriasis, rosacea, eczema, etc.)
• History of immunosupression/immune deficiency disorders.
• Current or history of uncontrolled disease such as asthma, diabetes, hyperthyroidism, etc.