Clinical and Dermoscopic Evaluation of Long-pulsed 1064 nm Nd-YAG Laser Versus Trichloroacetic Acid 20% in Treatment of Keratosis Pilaris
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change of clinical and dermoscopic scores of KP with Nd-YAG laser
研究概览
简要总结
Keratosis pilaris (KP) is a common disorder of keratinization. There are different treatment modalities for KP with variable results. Nd:YAG laser and chemical peels are among these treatment modalities, however, there is no enough evidence in the literature regarding their efficacy. The aim of this study is to assess and compare the efficacy of long pulsed Nd:YAG laser and trichloreacetic acid 20% in treatment of keratosis pilaris.
详细描述
Keratosis pilaris (KP) is a genetic disorder of keratinization of hair follicles of skin. It's a very common benign condition that manifests as small, rough folliculocentric keratotic papules, often described as chicken bumps, chicken skin or goose-bumps, in characteristic areas of body, particularly the outer upper arms and thighs.
Trichloreacetic acid (TCA) is a type of chemical peels that is derived from acetic acid by the chlorination of 3 hydrogen ions. It can induce coagulative necrosis of proteins and cells. The depth of action depends on various factors e.g the number of layers applied and its combination with substances that potentiate its action.
Nd: YAG laser is a type of hair removing devices that operates at wave length of 1064nm. This wave length allows for less absorption at the epidermis. It is less absorbed by melanin, which leads to lower side effect and better tolerance but less efficacy in dark skinned patients.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients above 18 years with KP.
- •Patients with KP affecting back of the trunk, arms, thighs, forearms, legs and buttocks.
排除标准
- •Pregnant or lactating females.
- •Patients who had performed any laser treatment for KP within 6 months prior to the study.
- •Patients with history of oral retinoids within 3 months prior to the study.
- •Patients with history of hypertrophic scars or keloids.
- •Patients who used any topical treatment one month prior to the session.
- •Patients with acne affecting the same sites of keratosis pilaris.
- •Patients with active skin diseases affecting the area involved with KP e.g. folliculitis and eczema.
研究组 & 干预措施
Nd-YAG laser
laser hair removal
干预措施: Nd-YAG laser (Device)
TCA 20%
chemical peel
干预措施: TCA 20% (Drug)
结局指标
主要结局
Change of clinical and dermoscopic scores of KP with Nd-YAG laser
时间窗: 4 months
the change in roughness and color of KP by clinical score after 4 sessions of Nd-YAG laser. the score ranges from 0-4. where 0 is no change and 4 is excellent improvement
Change of clinical and dermoscopic scores of KP with TCA 20%
时间窗: 4 months
the change in roughness and color of KP by clinical score after 4 sessions of TCA 20% peel. the score ranges from 0-4. where 0 is no change and 4 is excellent improvement
次要结局
- safety and tolerability of Nd-YAG laser and TCA 20% in treatment of KP: adverse events(4 months)
研究者
Dina Saadi
principal investigator
Cairo University