Laser Treatment for the Clinical Improvement of Acne Vulgaris: A Self-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Changes in Physician's Global Assessment (PGA) of Acne Severity
研究概览
简要总结
The goal of this clinical trial is to learn if fractional ablative laser can treat active acne vulgaris in adults 18 to 40 years old with moderate to severe acne vulgaris.
The main questions it aims to answer are:
Does ablative fractional carbon dioxide treatment effectively treat moderate to severe active nodular acne vulgaris?
Does ablative fractional carbon dioxide treatment effectively treat moderate to severe active nodular acne vulgaris over a short time frame?
Is non-selective laser useful in treating inflammatory skin disease?
How does the microbiome change after laser treatment?
Participants will...
- Receive up to 3 laser treatments
- Attend a baseline visit and follow-up visits post-treatment where participants will receive a clinical assessment, facial swab, and facial-imaging
详细描述
This study is designed to evaluate the efficacy of ablative fractional laser treatment for the clinical improvement or treatment of active acne vulgaris. We will be performing a self-controlled study, where each eligible subject will serve as their own control. Each subject will receive an ablative fractional 10,600 nm carbon dioxide laser treatment (Lumenis® Ultrapulse® C02 laser with DeepFX™ Yokneam, Israel).
There is another arm in the study. 22 subjects with acne will be selected to do the same laser treatment on a localized part of the face (1-3 inflammatory lesions and up to 5 mm adjacent area).
We plan to have 22 subjects complete the study on the first arm and 22 on the second arm. Both arms will be treated with the same device and the same energy and density will be used. The first arm will be submitted to 3 laser treatments, with a one-month interval between each treatment appointment and their full face will be treated. The second arm will have only one treatment and only 1-3 lesions will be submitted to the laser treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be able and willing to provide written informed consent and comply with the requirements of the study protocol;
- •In good general health, based on answers provided during the screening visit;
- •Subject must be able to read and understand English;
- •Any gender and any Fitzpatrick skin type;
- •Ages 18 through 40;
- •Subjects must have moderate to severe nodular active facial acne vulgaris (PGA 3 or 4)
- •Willing to sun protect treated area for the duration of enrollment in the study and 1 year after treatment;
- •Subjects must be ineligible for or have declined standard of care treatments (e.g. oral isotretinoin therapy).
排除标准
- •Participation in another investigational drug or device clinical trial in the past 30 days;
- •Currently undergoing or wish to begin or continue topical treatments;
- •Are pregnant or lactating;
- •History of allergic reaction to topical anesthesia;
- •Subjects may not have undergone oral isotretinoin therapy within the past 12 months;
- •Currently take oral antibiotic or oral therapy for acne;
- •History of keloidal or hypertrophic scarring;
- •Laser treatment in past six months;
- •History of poor wound healing;
- •Clinically significant abnormal findings or conditions which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
结局指标
主要结局
Changes in Physician's Global Assessment (PGA) of Acne Severity
时间窗: Change in PGA score between baseline visit and post procedural visit
The physician will score the acne vulgaris based on the Physician's Global Assessment (PGA) scale. A score of 0 indicates that residual hyperpigmentation and erythema may be present; a score of 1 indicates that there are a few scattered comedones and a few small papules; a score of 3 indicates that more than half of the face is involved, that there are many comedones, papules, and pustules, and that one nodule may be present; a score of 4 indicates that the entire face is involved, covered with comedones, numerous papules and pustules, and a few nodules and cysts. The change in PGA score will be recorded at each of the 4 study visits, for up to
次要结局
未报告次要终点
研究者
Dieter Manstein, MD
Principal Investigator
Massachusetts General Hospital