Within-subject, Investigator Initiated, Single-blind, Single-centre, Randomized Clinical Trial Investigating the Efficacy of Fractional Er:YAG Laser in Lupus Erythematosus Scars
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Average reduction of POSAS scar severity measure.
研究概览
简要总结
Cutaneous Lupus erythematosus (CLE) is a chronic autoimmune connective tissue disease with a prevalence of 14.6 - 73.2/100,000, predominantly in women in mid adulthood. Cutaneous lesions occur in about 75-80% of patients with systemic lupus erythematodes.These lesions unfortunately and invariably lead to significant scarring and postinflammatory hypo- and hyperpigmentation.
Several studies have reported that laser treatments in patients with CLE have a positive effect and safety. However, only few case reports exist about the effect of ablative lasers such as Carbon Dioxide (CO2) and Erbium-doped Yttrium Aluminum Garnet (Er:YAG) lasers in CLE scarring.
Although no study shows a flare-up of CLE after laser treatment of the scars, many physicians are afraid of treating these often stigmatizing scars. Considering the huge psychological impact of facial scaring on quality of life, it is essential to explore and assess the value of already well-established treatment options for the management of scars also in patients with cutaneous lupus erythematodes.
Hereby the study seeks the subjective and objective improvement of the CLE-scars after treatment with fractional Er:YAG laser compared to control (untreated) areas.
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
- •Informed consent
- •Skin type I-IV
- •Presence of >1 scar due to CLE at one localisation
- •Stable disease (without or with permanent therapy >3months)
排除标准
- •History of adverse events related to ablative fractional laser therapy
- •Ablative resurfacing within the last 6 months on the scar
- •Pregnant or breast feeding women
- •Intake of isotretinoin in the last 6 month
- •Intention to become pregnant during the course of the study
- •Any scar treatment in the last 3 month before inclusion
结局指标
主要结局
Average reduction of POSAS scar severity measure.
时间窗: 24 weeks
Average reduction from baseline of Patient and Observer Scar Assessment Scale (POSAS), ranging from 12 to 120 with higher score indicating a worst condition.
次要结局
- Overall average reduction of POSAS scar severity measure.(16 and 24 weeks)
- Cumulative incidence of localized disease flare-up.(4, 8, 12, 16 and 24 weeks)
- Overall average scar improvement according to physician global assessment.(4, 8, 12, 16 and 24 weeks)
- Average patient's satisfaction.(16 and 24 weeks)