1540nm Non Ablative Fractional Laser Treatment of Scars : a Prospective Single Blinded Within Patient Controlled Randomized Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Evaluation of the adverse effect of 1540nm fractional laser versus untreated control site
研究概览
简要总结
Scars are a frequent reason of consultation in a dermatological clinic. Their cosmetic aspect can play a key role in patient satisfaction and self-image.
Non ablative fractional infra-red laser treatment is a new concept in the laser field using arrays of microscopic thermal damage patterns to stimulate a wound healing response. There are different reports on the positive effect of these type of laser treatment in the treatment of acne scarring, striae, rythides, hypopigmented and hypertrophic scars.
The low morbidity of the treatment and the lack of satisfying treatment regimes for different types of scars makes it attractive to investigate the efficacy and safety of 4 treatment with the 1540nm non ablative fractional laser in the treatment of scars.
Objectives:
- To evaluate the efficacy of 4 laser treatments with Starlux 300 Lux 1540nm Fractional laser handpiece ( Palomar Medical Technologies ) 1 and 3 month after the last laser treatment for 3 different "scar" patient groups :
- Patients with hypopigmented scars
- Patients with hypertrophic scars
- Patients with scars due to grafts and reconstructions in the head and neck region.
- To evaluate the treatment related pain. on a categorical scale from 0-10
- To evaluate the adverse effect of 1540nm fractional laser versus untreated control in the 3 patient groups.
The study design is a prospective single blinded randomised within-patient controlled study The study involves 6 visits.
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 (Investigator)
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
- •The patients needs to have a scar fulfilling the inclusion and
排除标准
- •of one of the 3 patient groups:
- •Patient group 1: patients with hypopigmented scars :
- •Inclusion criteria:
- •Patients with a hypopigmented scar allowing 2 side by side test areas of similar sizes and appearance within the same anatomical region.
- •Skin type 1-4
- •Age at least 18 years old
- •Willingness and ability to give written informed consent and to comply with the requirements of the protocol
- •Exclusion criteria:
- •Pregnancy and lactation
- •Oral retinoid drugs within the past 6 months
- •Patientgroup 2: patients with hypertrophic scars :
- •Inclusion criteria:
- •Patients with a hypertrophic scar allowing 2 side by site test areas of similar sizes and appearance within the same anatomical region.
- •Skin type 1-4
- •Male / Female
- •Age at least 18 years old
- •Willingness and ability to give written informed consent and to comply with the requirements of the protocol
- •Exclusion criteria:
- •Pregnancy and lactation
- •Oral retinoid drugs within the past 6 months
- •Patient group 3: Patients with scars due to grafts and reconstructions in the head and neck region.
- •Inclusion criteria:
- •Patients with a graft or reconstruction with 2 site by site test areas of similar sizes and appearance within the same anatomical region (head and neck region).
- •Skin type 1-4
- •Age at least 18 years old
- •Willingness and ability to give written informed consent and to comply with the requirements of the protocol
- •Exclusion criteria:
- •Pregnancy and lactation
- •Oral retinoid drugs within the past 6 months
研究组 & 干预措施
hypertrophic scars not treated with laser
干预措施: treatment without laser (Procedure)
hypopigmented scars treated with laser
patients with hypopigmented scars treated with Starlux 300 Lux 1540nm Fractional laser hand piece
干预措施: laser treatment (Procedure)
hypopigmented scars treated without laser
patients with hypopigmented scars treated without laser
干预措施: treatment without laser (Procedure)
hypertrophic scars treated with laser
干预措施: laser treatment (Procedure)
scars due to grafts and reconstructions treated with laser
scars due to grafts and reconstructions in the head and neck region
干预措施: laser treatment (Procedure)
grafts and reconstructions scars not treated with laser
scars due to grafts and reconstructions in the head and neck region
干预措施: treatment without laser (Procedure)
结局指标
主要结局
Evaluation of the adverse effect of 1540nm fractional laser versus untreated control site
时间窗: at 1 and 3 months
efficacy of 4 laser treatments with Starlux 300 Lux 1540nm Fractional handpiece (Palomar Medical Technologies) 1 and 3 months after the last laser treatment in 3 different "scar" patient groups
时间窗: at 1 and 3 months
Evaluation of the treatment related pain
时间窗: at 1 and 3 months
次要结局
- Compare different clinical scar assessment tools that can be used in the evaluation of clinical efficacy of the laser treatment(at 1 and 3 months after treatment)
- Physician assessment for the treated and control region (PhGA)(at 1 and 3 months after treatment)
- patient assessment for the treated and control region(at 1 and 3 months after treatment)
- Evaluation of skin redness and pigmentation(at 1 and 3 months after treatment)
- Evaluation of histological difference in treated an non treated parts of the scar(at 3 months after treatment)
- Photografic documentation of scar improvement(at 1 and 3 months after treatment)