A Randomized Split-Face Controlled Trial Comparing Efficacy of 2940 Nanometer Er:YAG Laser to 2.5% BP Gel for the Treatment of Inflammatory Acne
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- percentage change from baseline of inflammatory acne lesion count at 6 week after 1st 2940nm Er:YAG laser treatment
研究概览
简要总结
Acne is one of the most common conditions that patients seek for help in dermatological clinic. Nowadays, conventional treatment including topical agents(retinoids, antibiotics ,antiseptics and keratolytic agents) and systemic agents( antibiotics and retinoids) give a satisfying result but not to every patient. Some patients are not well respond to conventional therapy while some patients are unable to tolerate side effects of the treatments. Therefore, interventions to reduce acne are vigorously experimented . Lights and lasers including intense pulsed light, pulsed dye laser with or without photosensitizer and infrared lasers have been found to be useful in treating active inflammatory acne. Although,pain ,downtime and poor response of comedonal acne are limitations of those lights and lasers therapy. 2940 nm Erbium:YAG laser which has both resurfacing and photothermal effects is our laser of interest to seek for its efficacy in the treatment of inflammatory acne.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 year-old to 45 year-old
- •Mild to moderate severity of acne vulgaris with at least 5 active inflammatory acne lesions on each side of the face and less than 25% difference in lesion count between each side of face
- •Fitzpatrick skin phototype I-IV
排除标准
- •History or clinical presentation of hypertrophic scar or keloid
- •Photoaggravated skin diseases i.e. systemic lupus erythematosus, polymorphous light eruption, solar urticaria
- •Oral isotretinoin taken within the last 6 months prior to enrollment
- •Topical retinoid within 4 weeks prior to enrollment
- •Systemic acne therapies (oral antibiotics) within 4 week prior to enrollment
研究组 & 干预措施
BP gel
干预措施: Benzoyl Peroxide gel (Drug)
结局指标
主要结局
percentage change from baseline of inflammatory acne lesion count at 6 week after 1st 2940nm Er:YAG laser treatment
时间窗: 6 week
% change from baseline = (NV- NB)/NB x 100% NV = number of lesion at each visit NB = number of lesion at baseline
次要结局
- Safety(week0,2,4)
- Photographic clinical improvement(week 2,4,6 and 10)
- Patient satisfaction(week 6)
研究者
Nattaporn Rojarayanont, M.D.
Faculty of Medicine, Department of Medicine, Dermatological unit
Chulalongkorn University