Short-pulse and Ultra-Short Pulse ND: YAG 1064 Lasers for Stasis Dermatitis Secondary to Chronic Venous Hypertension Treatment: the SUPERSTAR Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Colorimetry
研究概览
简要总结
This study tests two types of lasers (ND YAG 1064 short and ultra-short pulses) to treat hyperchromic skin lesions secondary to venous hypertension (stasis dermatitis)
详细描述
Background: Stasis dermatitis with hyperpigmented skin lesions is a serious health problem for patients with chronic venous hypertension. Although no randomized studies have evaluated lasers for this treatment, lasers can be an attractive option.
Methods: This prospective, randomized, 3-arm, open-label, vehicle-controlled study will enroll patients scheduled to undergo treatment for stasis dermatitis with hyperpigmented skin lesions. Patients will be allocated to either Nd: YAG 1064 nm short pulse laser-nanoseconds (group 1), or Nd: YAG 1064 nm ultra-short-pulse laser-picoseconds (group 2), or cold cream vehicle control (group 3). All treatments are scheduled for 6 visits with pre-defined dates, with a final follow-up visit at intervals of 28 to 35 days. Primary outcomes include colorimetry analysis, secondary outcomes pre- and post-photographic analysis, and DLQI quality-of-life assessment.
Conclusions: The results of this trial will provide high-quality evidence to guide clinical practice on optimal management of hyperpigmented skin lesions secondary to stasis dermatitis.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women or men aged 18 to 89 years with stasis dermatitis secondary to venous hypertension
- •Agreement with the terms of the survey and signing of the informed consent form
- •Availability to make the necessary appointments for treatment and follow-up
- •Provide consent to avoid pregnancy during treatment
- •Have primary venous hypertension already treated (treatment of varicose veins of the lower limbs) by any of the available techniques
排除标准
- •Men and women with CEAP 2 to 6, low mobility, no stasis dermatitis.
- •Peripheral arterial disease.
- •History of known allergy to the drugs used in this study
- •Presence of other types of dermatitis in the lower extremities, such as allergic stasis eczema.
- •Presence of comorbidities (such as diabetes mellitus, heart failure, respiratory failure, hypertension, hypothyroidism, or hyperthyroidism), pregnancy, breastfeeding, pulmonary hypertension, deep vein thrombosis (DVT), family history of DVT, known hypercoagulable states or thrombophilia, asthma, and migraine.
- •Anyone who does not agree with any of the search terms.
研究组 & 干预措施
Arm 3
Control vehicle (cold cream)
干预措施: cold cream (Drug)
结局指标
主要结局
Colorimetry
时间窗: 6 months
The skin tone dissimilarity (expressed as ΔE) at treated and adjacent areas measured with digital calorimetry. The ΔE value derives from the differences in the International Commission on Illumination L\*a\*b\* (CIELAB) color space. It is a structured approach to quantifying color differences, with specific intervals indicating varying levels of perceptibility with different intensities of pigmentation: * 0 \< ∆E \< 1 - the difference is unnoticeable * 1 \< ∆E\< 2 - the difference is only noticed by an experienced observer (mild), * 2 \< ∆E \< 3.5 - the difference is also noticed by an inexperienced observer (light), * 3.5 \< ∆E \< 5 - the difference is noticeable (moderate), * 5 \< ∆E - gives the impression that these are two different colors (intense) In all sessions, patients will be submitted to colorimetric analysis. The ∆E is the skin color difference between the treated and adjacent areas.
次要结局
- Photographic analysis(6 months)
- Number of participants with treatment-related adverse events as assessed by clinical evaluation.(6 months)
研究者
Eduardo Ramacciotti
Senior investigator
Science Valley Research Institute