NCT02492373已完成不适用
Effect of Topical Corticosteroids on the Incidence of Postinflammatory Hyperpigmentation Following Q-switched Nd:YAG 532 nm Laser for Treatment of Facial Lentigines - A Pilot Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- The incidence of post inflammatory hyperpigmentation
研究概览
简要总结
To investigate the benefit of the application of topical high potency steroid on the incidence of post inflammatory hyperpigmentation after laser treatment.
详细描述
- The incidence of post inflammatory hyperpigmentation (PIH) after treating lentigines with Q-switched Nd:YAG laser was 78.3%.
- It has been found that the incidence of PIH decreased to 40% after applied topical high potency steroid 2 days after the laser treatment.
- By these anti-inflammatory and anti-PIH effects of the high potency steroid, the investigators aimed that the application of steroid 2 days before and 2 days after the laser treatment would be better reduction in the incidence of PIH after Q-switched Nd:YAG laser.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Having multiple lentigines on both sides of the face
- •Fitzpatrick skin phototype 3-5
排除标准
- •Patients with lesions with any clinical suspicion of being pre-cancerous or skin malignancies of any kind
- •Patients who have photosensitive dermatoses
- •Pregnancy and lactation woman
- •Patients with wound infections (herpes, other) on the day of treatment
- •Patients with moderate and severe inflammatory acne, Immunosuppressed patients, history of vitiligo
- •Patients with unrealistic concerns/expectations and inability to do the appropriate post-operative care
研究组 & 干预措施
laser+steroid 2 days before and after laser
Active Comparator
Before lentigines' treatment with Qs Nd:YAG 532 nm laser, topical 0.05% Clobetasol propionate ointment was applied 2 days on the lesion. Then applied 2 days after the treatment.
干预措施: topical 0.05% Clobetasol propionate ointment (Drug)
laser+steroid 2 days after laser
Other
Controlled side. Applied topical 0.05% Clobetasol propionate ointment only 2 days after the laser treatment
干预措施: topical 0.05% Clobetasol propionate ointment (Drug)
结局指标
主要结局
The incidence of post inflammatory hyperpigmentation
时间窗: 2 weeks
By investigator's observation.
次要结局
- Side effects of topical steroid(Follow-up 2, 3, 4, 8, 12 and 24 weeks after the last treatment)
- The patients satisfaction(Follow-up 4, 8, 12 and 24 weeks after the last treatment)
研究者
Woraphong Manuskiatti, M.D.
Professor
Mahidol University
研究点 (1)
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