Efficacy and Safety of Topical Cysteamine for Postinflammatory Hyperpigmentation: A Randomized Control, Double Blinded-trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from Baseline Pigmentation at 4 Weeks
研究概览
简要总结
Post-inflammatory hyperpigmentation is a common pigmentary skin disorder that is refractory to treatment. The treatment for postinflammatory hyperpigmentation is limited. Recent studies have shown that the topical skin care product cysteamine cream has a significant decrease in melanin index without obvious side effects in other dark spots such as melasma. The goal of this study is to determine the safety and efficacy of topical cysteamine in the treatment of post-inflammatory hyperpigmentation.
详细描述
Post-inflammatory hyperpigmentation is a common pigmentary skin disorder that is refractory to treatment and troublesome for darker skin individuals. The current treatment with conventional bleaching cream may result in skin irritation and ochronosis that is irreversible. Recent studies have shown that the topical cysteamine cream is safe and effective for dark spots such as melasma and lentigo with no significant side effects.
The primary aim of this study is to evaluate the safety and efficacy of topical cysteamine for postinflammatory hyperpigmentation. We conduct a randomized control, double-blinded trial to include 40 patients with postinflammatory hyperpigmentation. Clinical photography with VISIA skin imaging system,mexameter, transepidermal water loss, optical coherence tomography were used to evaluate the efficacy of treatment on a monthly basis for four months period. The patient was evaluated by two blinded investigator using the investigator global assessment. Patient global assessment was also recorded monthly.
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
- Double (Participant, Investigator)
盲法说明
The packaging and labeling of the topical product were the same in both group. The subjects were randomized in by an interactive web response system that provided study kit number from the randomization list at the time of inclusion into the study. The randomization list was kept strictly confidential throughout the study and was not available to the investigator and patient or any other personnel who may influence the study data.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Over 20 years old
- •Patients with postinflammatory hyperpigmentation for more than 3 months.
排除标准
- •Patients with topical hydroquinone, oral tranexamic acid and/or other skin whitening agents.
- •Patients that receive or planning to receive laser treatment for spot removal during the study period.
- •Individuals with allergic history to cysteamine or vehicle ingredients.
- •Pregnant patients or patients planning to become pregnant during the time of the study.
研究组 & 干预措施
20 participants with topical cysteamine cream
Participants with post-inflammatory hyperpigmentation will apply topical cysteamine cream for a 16 weeks period.
干预措施: Topical Cysteamine (Drug)
20 participants with topical vehicle control cream
Participants with post-inflammatory hyperpigmentation will apply topical vehicle-control cream for a 16 weeks period.
干预措施: Topical Vehicle Control (Drug)
结局指标
主要结局
Change from Baseline Pigmentation at 4 Weeks
时间窗: 4 weeks
Patients will have their lesion pigmentation scored with the hyperpigmentation index after 4 weeks
Change from Baseline Pigmentation at 8 Weeks
时间窗: 8 weeks
Patients will have their lesion pigmentation scored with the hyperpigmentation index after 8 weeks
Change from Baseline Pigmentation at 12 Weeks
时间窗: 12 weeks
Patients will have their lesion pigmentation scored with the hyperpigmentation index after 12 weeks
Change from Baseline Pigmentation at 16 Weeks
时间窗: 16 weeks
Patients will have their lesion pigmentation scored with the hyperpigmentation index after 16 weeks
次要结局
未报告次要终点