Comparison of Fractionated 1,540nm Nonablative Laser and Microneedling in the Treatment of Atrophic Acne Scarring in Skin of Color: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in the Goodman and Baron score
研究概览
简要总结
Atrophic acne scars are a common and important sequelae of acne that affect up to 43-55% of patients with acne. Scarring impacts quality of life with reports of diminished self-esteem and frustration/sadness; additionally, some individuals report that their appearance even interferes with their professional lives. Though many treatments for acne scarring exist including ablative and nonablative lasers, subcision, and peels, none is without risk of adverse effects of pain, post-procedure redness or pigmentary changes. There have been no randomized studies directly comparing the effectiveness and safety profiles of microneedling (Dermapen) to 1,540nm nonablative fractional lasers (Palomar StarLux) in the treatment of atrophic acne scarring in skin of color. This clinical trial aims to determine which treatment modality -- microneedling or nonablative fractional laser -- is safer and more efficacious in the treatment of acne scarring in patients with skin of color.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients referred to dermatology clinic for any reason, or resident or attending dermatologists at Boston University.
- •Individuals (men and women) aged 18 and older
- •Patients must have atrophic facial acne scarring on the face and desire treatment to improve appearance of acne scarring
- •Patients must have Fitzpatrick skin type III-VI
- •Patients must be willing to receive five acne scarring treatments at monthly intervals with one follow-up visit to assess for efficacy and adverse effects
- •Subjects must speak either English, Chinese, or Spanish.
排除标准
- •Subjects who are unable or unwilling to give informed consent.
- •Personal history of photosensitivity or photosensitive diseases.
- •Pregnancy or breast-feeding.
- •Facial surgical or laser treatment in the last 3 months.
- •Patients with any active skin infection in the treatment area.
- •Coagulopathies or anticoagulant therapy.
- •Personal history or presence of hypertrophic scars or keloids.
结局指标
主要结局
Change in the Goodman and Baron score
时间窗: Before treatment starts and 3 months after the last/5th treatment
The Goodman and Baron score considers type of scar, number of scars, and severity of scarring and assigns a grade 1-4 with grade 1 representing mild, macular disease and grade 4 representing severe scarring that is obviously visible at social distances of 50cm, is not easily covered by makeup, and is not able to be flattened by manual stretching of the skin. Lower scores are favorable.
次要结局
- Treatment satisfaction(3 months after the last/5th treatment)
- Impact of skin disease on the quality of life(3 months after the last/5th treatment)