Non-ablative 1,550 nm Fractional Laser Therapy Versus Triple Topical Therapy for the Treatment of Melasma: a Randomized Controlled Split-face Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 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 non-ablative fractional laser is safe and effective in the treatment of melasma.
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
- •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).
研究组 & 干预措施
Non-ablative fractional laser
In each patient, one side of the face was treated with non-ablative fractional laser in four-five sessions.
Note: this study had a split-face design. In each patient, each side of the face was randomized to receive either non-ablative fractional laser therapy or triple topical therapy.
干预措施: Fraxel Restore, Solta Medical Inc. (Non-ablative fractional laser) (Device)
Triple topical therapy
In each patient, one side of the face was treated with triple topical therapy (Hydroquinone 5%, tretinoin 0.05%, triamcinolone acetonide 0.1%) during 15 weeks.
Note: this study had a split-face design. In each patient, each side of the face was randomized to receive either non-ablative fractional laser therapy or triple topical therapy.
干预措施: Modified Kligman's formula (Triple topical therapy) (Drug)
结局指标
主要结局
Physician's global assessment
时间窗: T0, 3 weeks, and 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 weeks and 3 and 6 months follow-up)
- Melanin index(T0, 3 weeks and 3, and 6 months follow-up)
- Patient's global assessment(3 weeks, 3 and 6 months follow-up)
- Patient's satisfaction(3 weeks, 3 and 6 months follow-up)