Comparison of the Efficacy of Potassium-titanyl Phosphate (KTP) Laser vs KTP Laser Combined With Ivermectin 1% Cream for Facial Rosacea: a Randomized Split-face Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Efficacy of laser and cream vs laser alone in reducing erythema as assessed by NEI
研究概览
简要总结
Rosacea is a frequent chronic inflammatory disease affecting mainly the face but also eyes and scalp. Rosacea is classified into 3 types: erythemato-teleangiectatica, papulopustulosa and phymatosa. Treatments depend on the type and include topical and systemic antibiotics, azelaic acid, topical ivermectin, topical brimonidine, systemic isotretinoin as well as intense pulsed light (IPL) and laser therapies.
For treatment of telangiectasia and redness, laser and IPL therapies are the first choice. Vascular lasers, such as pulsed dye lasers (PDL) and potassium-titanyl phosphate (KTP) lasers as well as IPL, have demonstrated good efficacy in reduction of erythema and telangiectasias in patients with rosacea. However, these treatments are expensive and mostly not covered by the health insurance. Therefore, for patients it is important to receive the maximal effect and improvement after each single laser session.
Ivermectin is a semi-synthetic derivative of avermectin and has an anti-inflammatory effect as well as an antiparasitic effect on demodex mite. The latter is playing an important pathogenetic role in rosacea.
This randomized controlled study aims to compare the effect of KTP laser in combination with ivermectin 1% cream vs KTP laser alone in patients with facial rosacea.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fitzpatrick skin type I-IV
- •Presence of facial erythematous rosacea or mild papulopustular rosacea with permanent erythema
- •Informed consent signed
排除标准
- •History of adverse events related to KTP laser therapy
- •Pregnant or breastfeeding women
- •Intention to become pregnant during the course of the study
- •History of intolerance or allergic reaction to ivermectin 1% cream or one of the ingredients
- •Ongoing treatment for skin cancer
- •Ongoing treatment with strong inhibitors of P-glycoprotein (P-gp) and CYP3A4 (e.g., itraconazole, voriconazole, posaconazole, clarithromycin, cobicistat)
- •Ongoing treatment with substances with a narrow therapeutic range whose excretion depends substantially on P-gp (e.g. digoxin, ciclosporin)
- •Inability to understand the study content
研究组 & 干预措施
Laser and cream
干预措施: KTP laser (Device)
Laser and cream
干预措施: Ivermectin 1% cream (Drug)
Laser alone
干预措施: KTP laser (Device)
结局指标
主要结局
Efficacy of laser and cream vs laser alone in reducing erythema as assessed by NEI
时间窗: 16 weeks
Any relative decrease of erythema on the side treated with KTP laser and ivermectin 1% cream vs laser alone as assessed by Normalized Erythema Index (NEI), ranging from 0 to 80, with higher values indicating a worst erythema.
次要结局
- Efficacy of laser and cream vs laser alone in the clinical improvement of skin lesions as assessed by PGA(4, 8, 12, 16 weeks)
- Patient's satisfaction related to laser and cream vs laser alone in the improvement of skin lesions as assessed by VAS(4, 8, 12, 16 weeks)
- Efficacy of laser and cream vs laser alone in reducing papules and papulopustules(4, 8, 12, 16 weeks)
- Efficacy of laser and cream vs laser alone in reducing face purpura as assessed by the patient(4, 8, 12, 16 weeks)
- Efficacy of laser and cream vs laser alone in reducing face swelling as assessed by the patient(4, 8, 12, 16 weeks)
- Efficacy of laser and cream vs laser alone in reducing erythema as assessed by SRI(16 weeks)
- Efficacy of laser and cream vs laser alone in reducing telangiectasia severity as assessed by TGS(4, 8, 12, 16 weeks)
- Efficacy of laser and cream vs laser alone in reducing face redness as assessed by the patient(4, 8, 12, 16 weeks)
- Efficacy of laser and cream vs laser alone in reducing erythema as assessed by CEA(4, 8, 12, 16 weeks)