Ablative Fractional Laser Therapy as Treatment for Becker's Nevus; a Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 主要终点
- Physician's global assessment
研究概览
简要总结
The purpose of this study is to determine whether the use of ablative fractional laser is effective in the treatment of Becker's nevus.
详细描述
Becker's nevus (BN) is an uncommon pigment disorder of the epidermis characterized by increased pigmentation, a slightly elevated, verrucous surface of the affected skin and sometimes hyperpigmentation. No effective treatment is available. Several laser modalities have been applied in the treatment of Becker's nevus in uncontrolled studies with varying results. Recently, fractional laser therapy was suggested as treatment option for Becker's nevus. In fractional laser therapy, microscopic columns of skin are coagulated or ablated, leaving the surrounding tissue intact, which enhances healing of the treated skin. In this study, the efficacy and safety of ablative fractional laser therapy was assessed in the treatment of Becker's nevus.
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
- •Becker nevus
- •Subjects attending the outpatient department of the Netherlands Institute for Pigment Disorders
- •Age at least 18 years
- •Subject is willing and able to give written informed consent
排除标准
- •use of bleaching creams during the past six weeks
- •history of keloid
- •active eczema
- •suspected hypersensitivity to lidocaine or triple therapy
- •use of isotretinoin in the past six months
- •high exposure of the lesion to sunlight or UV light (UVA or UVB).
结局指标
主要结局
Physician's global assessment
时间窗: T0, 3 and 6 months follow-up
Improvement of hyperpigmentation was assessed by an independent blinded dermatologist. The results were scored on a scale from zero to six (0: total clearance (100% improvement), 1: almost total clearance (90-99% improvement), 2: distinct clearance (75-89% improvement) 3: moderate clearance (50-74% improvement) 4: mild clearance (25-49% improvement) 5: no change, 6: worsening of hyperpigmentation).
次要结局
- L-value(T0, 3 and six months follow-up)
- Melanin index(T0, 3 and 6 months follow-up)
- Patient's global assessment(3 and 6 months follow-up)
- Patient's satisfaction(3 and 6 months follow-up)
- Histopathologic assessment(3 months follow-up)