Efficacy and Safety of the Fractionated 1927-nm Non Ablative Thulium Laser in Treating Post Inflammatory Hyperpigmentation in Skin Phototypes IV-VI
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Degree of Pigmentation in all 5 subjects
研究概览
简要总结
To study the effect of fractionated 1927-nm non ablative thulium laser in reduction of post inflammatory hyperpigmentation (PIH) using a validated and reproducible model for studying PIH.
- Determine if there is aa reduction in PIH in patients treated with three (3) monthly sessions of fractionated 1927-nm non ablative thulium laser
- Determine if there is efficacy of post-procedure clobetasol propionate 0.05% ointment in the management of PIH
- Determine the histological and molecular changes that occur with laser and laser plus topical steroid treatment compared to untreated skin
详细描述
The design of the study consists of a total of six visits including one initial screening visit within 107-127 days depending on the scheduling of your screening and subsequent visits. Assessments such as visual examination, photography, Investigatory Global Assessment (IGA) of pigmentation and erythema; Colorimetry; and Diffuse Reflectance Spectroscopy of the intended treatment area will be conducted at Visits 1-5. Optional biopsies will be taken at various time points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient age 18 and older
- •Patient with skin phototypes IV-VI
- •Patient able to understand requirements of the study and risks involved
- •Patient able to sign a consent form
- •Patient to have discontinued all oral medications used to treat pigmentary abnormalities and all topical medications, except for sunscreen, used to treat pigmentary abnormalities on the buttocks one month prior to treatment
排除标准
- •A patient who has skin dyspigmentation, birth marks, tattoos, or other skin findings at baseline on either buttock that may obscure study results
- •A patient who is lactating, pregnant, or planning to become pregnant
研究组 & 干预措施
Fractional laser patients treated with laser
Laser with topical steroid and laser with vehicle.
干预措施: Patients treated with laser (Device)
结局指标
主要结局
Degree of Pigmentation in all 5 subjects
时间窗: Visit 1 (Day 0) through Visit 5 (Day 112 ±5)
Measured clinical with IGA objectively with colometry
次要结局
- Immunohistochemical changes in pigmentation in all 5 subjects(Visit 2 (Day 28±5) and Visit 5 (Day 112 ±5))
- Immunohistochemical changes in inflammation in all 5 subjects(Visit 2 (Day 28±5) and Visit 5 (Day 112 ±5))
研究者
Tasneem Mohammad
Staff Physician, Department of Dermatology
Henry Ford Health System