Ablative Fractional Laser Treatment for the Improvement of Hypertrophic Scars and Scleroderma: a Prospective Cohort Study
概览
- 阶段
- 不适用
- 干预措施
- Laser Treatment
- 疾病 / 适应症
- Scars
- 发起方
- Massachusetts General Hospital
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Change in Vancouver Scar Scale Score Post-Treatment
- 状态
- 终止
- 最后更新
- 29天前
概览
简要总结
In this study, the investigators seek to evaluate the effects of a laser treatment on the redistribution/regeneration of collagen on the clinical, microscopic, and molecular profiles of hypertrophic scars and scleroderma.
详细描述
This study is designed to evaluate the efficacy of laser treatment for the improvement of the clinical appearance of disorders of collagen metabolism, including hypertrophic scars and scleroderma. The investigators will be performing a prospective cohort study. The entire lesion will receive laser treatment only. The investigators plan to have 20 patients (10 patients with hypertrophic scars and 10 patients with scleroderma) complete the study. Subjects must be equal to greater than 18 years old, but may be any gender or Fitzpatrick skin type. They must have one of the following: at least one extragenital hypertrophic scar, or at least one extragenital area of scleroderma . Subjects must not have received any prescription or in-clinic medications or treatments, such as intralesional corticosteroids or excision, on the eligible scars/scleroderma in the previous 3 months. Those on anti-inflammatory or immunosuppressive medications will also be excluded.
研究者
Dieter Manstein, MD
Principal Investigator
Massachusetts General Hospital
入排标准
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;
- •Age equal to or greater than 18 years old;
- •Subjects in the hypertrophic scar branch must have at least one extragenital hypertrophic scar (defined as abnormal proliferation of scar tissue that forms at the site of cutaneous injury and does not regress and grows beyond the original margins of the scar) large enough to treat for both the control and experimental arm (at least 4cm in length for spit scar treatment) or two similar hypertrophic scars (at least 4cm2 for each);
- •Subjects in the scleroderma branch must have eligible extragenital lesions; large enough to treat for both the control and experimental arm or two similar scleroderma areas (at least 4cm2 area for each);
排除标准
- •Participation in another investigational drug or device clinical trial in the past 30 days;
- •Are pregnant or lactating;
- •Use of any prescription or in-clinic medications or treatments, such as intralesional corticosteroids or excision, on the eligible scars/scleroderma in the previous 3 months;
- •History of allergic reaction to topical or local anesthesia;
- •Regular intake of high doses of anti-inflammatory drugs (aspirin \>81 mg/day, ibuprofen, corticosteroids, etc.) or immunosuppressive drugs;
- •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.
研究组 & 干预措施
Scars
The entire hypertrophic scar will receive laser treatment only.
干预措施: Laser Treatment
Scleroderma
The entire lesion will receive laser treatment.
干预措施: Laser Treatment
结局指标
主要结局
Change in Vancouver Scar Scale Score Post-Treatment
时间窗: 4 months
The Vancouver Scar Scale (VSS) is a clinical assessment tool used by healthcare professionals to evaluate the severity and characteristics of scars. It helps clinicians measure how abnormal a scar is compared with normal skin and track changes over time or with treatment. The total score range is 0-13 where a score of 0 indicates normal skin (no abnormal scarring), and a higher score indicates more severe scar features. Therefore, a negative change in Vancouver Score Scale (VCC) post-treatment indicates that the scar improved.
Physician's Global Assessment Scale
时间窗: Up to 1 year after baseline
A score of 0 denotes "No evidence of disease, 100% improvement" and "Completely clear." A score of 1 denotes "Very significant clearance (≥90% to 100%); only traces of disease remain" and "Almost Clear." A score of 2 denotes "Significant improvement(≥75% to \< 90%); some evidence of disease remains" and "Marked Improvement." A score of 3 denotes "Intermediate between slight and marked improvement (≥50% to \<75%)" and "Moderate Improvement." A score of 4 denotes "Some improvement (≥25% to \<50%); significant evidence of disease remains" and "Slight Improvement ." A score of 5 denotes "Disease has not changed from baseline (+ or - \<25%)" and "No Change." A score of 6 denotes "Disease is worse than at baseline by ≥25% or more" and "Worse."
次要结局
- Mouth Handicap in Systemic Sclerosis scale(Compare baseline to post-procedural)
- Range of Motion Evaluation(Compare baseline to post-procedural)
- Vancouver Scar Scale(Compare baseline to post-procedural)