The Effects of Fractional CO2 Laser on Poikiloderma of Civatte
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in Overall Improvement of Poikiloderma of Civatte (POC) From Baseline at 12 Weeks
研究概览
简要总结
This study will assess the safety and efficacy of fractional CO2 laser treatment for Poikiloderma of Civatte (POC).POC is a chronic vascular and pigmentary disorder typically involving the lateral and inferior neck region, as well as the chest area. Clinically, poikiloderma appears as a combination of telangiectasia, irregular pigmentation, and atrophic changes.Little data exist regarding the use of fractional CO2 laser for management of POC. This study hopes to fulfill this purpose. The primary outcome will be a blinded assessment by dermatologists in the improvement in POC using the Physician's Global Aesthetic Improvement Scale following therapy. The secondary outcomes include subject satisfaction post-treatment and assessment of all procedure-related adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Male and female subjects, English and non-English speakers, and subjects more than 18 years old
- •Clinical diagnosis of poikiloderma of Civatte affecting the neck and chest
- •Agree to not undergo any other procedures on the neck and chest area during the study
- •Agree to refrain from tanning for 6 months post-procedure
- •Willing and able to read, understand, and sign the consent form
- •Willing and able to adhere to the treatment and follow-up schedule as well as post-treatment care
排除标准
- •Patients under 18 years old
- •Active skin infection, dermatitis, or a rash on the treatment area
- •Pregnant or lactating patients
- •Patients on immunosuppressive medications
- •Any laser procedures or chemical peel procedures on the neck or chest area within the past 6 months
- •Patients with multiple comorbidities such as diabetes mellitus, cardiovascular diseases, neurologic disorders, internal malignancies
- •Personal history or family history of forming keloids or hypertrophic scars, or abnormal wound healing
- •Patients with known bleeding disorders or taking more than one anticoagulation medications
- •Undergoing any surgery in the treatment area within the past 12 months
- •History of radiation to the head, neck, and chest area
- •Systemic use of isotretinoin within 6 months
- •Any use of gold therapy
- •Current smoker or history of smoking within 12 months of study
- •Any physical or mental condition in which the investigators deem unsafe for the subject to participate in the study.
- •History of recurrent herpes simplex on the neck or chest.
结局指标
主要结局
Change in Overall Improvement of Poikiloderma of Civatte (POC) From Baseline at 12 Weeks
时间窗: Baseline, 12 weeks
Improvement of Poikiloderma of Civatte (POC) at 12 weeks post treatment is assessed by the Physician's Global Aesthetic Improvement Scale which is a 10-point scale. Each dermatologist from an independent panel (blinded to treatment parameters and the treatment laterality at each photograph time point) will be asked to identify the baseline and post-treatment images from randomized, paired images for all subjects. Reviewers will rate improvement of POC in 10% increments on a 10-point scale (0% no improvement to 100% or complete clearance).
Change in Overall Improvement of Poikiloderma of Civatte (POC) From Baseline at 24 Weeks
时间窗: Baseline, 24 weeks post-treatment
Improvement of Poikiloderma of Civatte (POC) at 24 weeks post treatment is assessed by the Physician's Global Aesthetic Improvement Scale which is a 10-point scale. Each dermatologist from an independent panel (blinded to treatment parameters and the treatment laterality at each photograph time point) will be asked to identify the baseline and post-treatment images from randomized, paired images for all subjects. Reviewers will rate improvement of POC in 10% increments on a 10-point scale (0% no improvement to 100% or complete clearance)
次要结局
- Patient Satisfaction Assessment Scores at 24 Weeks Post Treatment(24 weeks post-treatment)
- Number of at Least One Procedure-related Adverse Events(24 weeks post-laser treatment)
- Patient Satisfaction Assessment Scores at 12 Weeks Post Treatment(12 weeks post-treatment)
研究者
Heather Woodworth Goff
Primary Investigator
University of Texas Southwestern Medical Center