A Randomized Split-face Study of a Precision Cryotherapy Via Boosting Mode Combined With Tranexamic Acid Versus Normal Saline in the Treatment of Melasma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- The change of Melasma Area and Severity Index score
研究概览
简要总结
This study aimed to evaluate the effectiveness of a precision cryotherapy via boosting mode combined with tranexamic acid versus normal saline in the treatment of melasma. Eighteen patients aged 25 to 60 years diagnosed with epidermal-typed melasma sized equal to or more than 2 cm on both cheeks were included. The patients were treated with a precision cryotherapy via boosting mode combined with tranexamic acid and normal saline on each side of cheek for 4 times every 1 week. Then, they were follow up at 1 and 3 months after the last treatment. Subjective assessment of physician and patient improvement were evaluated. Moreover, Melasma Area and Severity Index (MASI), melanin and erythema index using Mexameter were also recorded.
详细描述
TargetCool via boosting mode combined with tranexamic acid versus normal saline were studied in patients diagnosed with epidermal-typed 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patients diagnosed with epidermal-type melasma sized equal to or more than 2 cm on both sides of cheeks
- •Fitzpatrick skin type II-IV
排除标准
- •Pregnant or lactation
- •Subjects who have been treated with any kind of energy-based device 6 months prior to the inclusion
- •Subjects who have been treated with topical or oral treatment for melasma 6 months prior to the inclusion
- •Subjects who allergy to cryotherapy such as cryoglobulinemia, cold urticaria, and abnormal cold tolerance
- •Subjects with abnormal sensation such as diabetes mellitus
- •Active skin infections
- •History of hypertrophic scars or keloids History of hypertrophic scars or keloids
研究组 & 干预措施
cryotherapy with tranexamic acid
precision cryotherapy via boosting mode combined with tranexamic acid
干预措施: TargetCool (Device)
cryotherapy with normal saline
precision cryotherapy via boosting mode combined with normal saline
干预措施: TargetCool (Device)
结局指标
主要结局
The change of Melasma Area and Severity Index score
时间窗: Baseline, 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment
Two blind dermatologists evaluated Melasma Area and Severity Index score on each side of cheek in every visits (0-48; best to worse)
次要结局
- Physician improvement score(1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment)
- the changes in erythema index(Baseline, 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment)
- the changes in melanin index(Baseline, 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment)
- Side effects(Baseline, 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment)
- Overall improvement by patients(1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment)
研究者
Woraphong Manuskiatti, M.D.
Prof. Dr.
Mahidol University