Fractional Laser Abrasion in Combination With UVB Therapy in Vitiligo Patients: a Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Repigmentation % with sheets
研究概览
简要总结
Rationale: Vitiligo is a common skin disorder that can impair a patient's quality of life. Many depigmented lesions in vitiligo patients remain therapy resistant for medical treatment. Therefore new therapeutic options in these patients are necessary. Currently, dermabrasion by conventional or fractional laser therapy in combination with NB-UVB therapy and steroids appears to be effective in therapy resistant areas. However, little literature on this combination is available.
Objectives: To assess the efficacy and patient safety of (1)fractional CO2-laser treatment in combination with NB- UVB,(2) fractional CO2-laser treatment in combination with NB- UVB and topical corticosteroids versus NB-UVB treatment alone(3) Study design: Prospective observer blinded randomised intra-patient controlled study.
Study population: 23 patients ≥ 18 years with non segmental vitiligo who receive NB-UVB treatment at the Netherlands Institute for Pigment Disorders (SNIP) at the Academic Medical Centre University of Amsterdam. We will include patients with 3 depigmented lesions that are resistant to NB- UVB treatment after 3 to 6 months.
Methods: Three NB-UVB resistant depigmented regions on the trunk or extremities will be randomly allocated to;(1) NB-UVB treatment in combination with fractional CO2 laser abrasion, or (2) NB-UVB treatment in combination with fractional CO2 laser abrasion and topical steroids, or (3) NB-UVB treatment alone. NB-UVB treatment and topical steroids will be given according to the standard treatment protocol of the SNIP and continued for at least 6 months. Two and 6 months after the laser treatment, the percentage of repigmentation of the lesions will be assessed.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Laser+fluticason+UVB
The treatment site will be superficially abraded using an ablative fractional laser (10,600nm CO2 laser). 5 days after laser therapy topical steroids (fluticasone cream) 4 times a week will be applied on the treatment site until the end of the study.
干预措施: Fractional CO2 laser (Device)
Laser+fluticason+UVB
The treatment site will be superficially abraded using an ablative fractional laser (10,600nm CO2 laser). 5 days after laser therapy topical steroids (fluticasone cream) 4 times a week will be applied on the treatment site until the end of the study.
干预措施: NB-UVB therapy (Other)
Laser+fluticason+UVB
The treatment site will be superficially abraded using an ablative fractional laser (10,600nm CO2 laser). 5 days after laser therapy topical steroids (fluticasone cream) 4 times a week will be applied on the treatment site until the end of the study.
干预措施: Fluticasone Propionate Cream 0.05% (Drug)
Laser+UVB
In one session the treatment site will be superficially abraded using an ablative fractional laser (10,600nm CO2 laser).
干预措施: Fractional CO2 laser (Device)
Laser+UVB
In one session the treatment site will be superficially abraded using an ablative fractional laser (10,600nm CO2 laser).
干预措施: NB-UVB therapy (Other)
UVB
As control site, 1 similar depigmented lesion will be used. This site will receive the same NB-UVB treatment as sites 1 and 2.
干预措施: NB-UVB therapy (Other)
结局指标
主要结局
Repigmentation % with sheets
时间窗: 6 mo after treatment
% of repigmentation
次要结局
- Global assessment physician(6 months after treatment)
- Global assessment patient(6 months after treatment)
- Visual assessment of hyperpigmentation/hypopigmentation/scar formation(6 months after treatment)
- Global assessment of repigmentation physician(6months after treatment)
研究者
JELommerts
MSc MD
Netherlands Institute for Pigment Disorders