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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Clinician's Global Aesthetic Improvement Assessment (CGAIS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Clinician's Global Aesthetic Improvement Assessment (CGAIS)
时间窗: 1 month post treatment, and 6 months post treatment
Clinician's Global Aesthetic Improvement Assessment: minimal score is 1- Very much improved and, maximum score is 5 -Worse: The appearance is worse than the original condition
Severity of Acne Scars
时间窗: Baseline, 1 month post treatment, and 6 months post treatment
Goodman and Baron's Qualitative grading system. Possible scores range from 1 = mild to 4 = severe.
次要结局
- Subject Self-Assessment Using SASIS(One Month Post Treatment, 6 Month Post Treatment)
- Photo Grading of Acne Scar Assessment(Day 1 (Baseline), Day 30, Day 60, 1-Month post treatment and 6 Month post treatment)
- Subject Self-Assessment Using Global Aesthetic Improvement Scale (SGAIS)(1-Month Post Treatment and 6- Month Post Treatment)