Effects of Botulinum Toxin Type a Treatment on Clinical and Biophysical Parameters in Patients With Erythematotelangiectatic Rosacea: A Prospective, Randomized, Placebo-controlled, Double-masked Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Evaluation of erythema using mexameter
研究概览
简要总结
Investigation of the effectiveness of intradermal botulinum toxin A treatment in the treatment of erythematotelangiectatic rosacea (ETR) using clinical, biophysical, dermatoscopic and videocapillaroscopy.
详细描述
There is no gold standard treatment for erythematotelangiectatic rosacea (ETR). In recent years, some studies have been conducted to demonstrate the efficacy of intradermal botulinum toxin A (BoNT-A) treatment in ETR and facial erythema. Studies including objective and quantitative measurements are limited.
This study aims to investigate the efficacy and safety of intradermal BoNT-A treatment in ETR patients.
This randomised, double-blind, split-face study included 30 participants with erythematotelangiectatic rosacea (ETR). They were randomly randomised to intradermal BoNT-A on one side of the face and placebo on the other side. Clinician's erythema assessment (CEA) score, patient self-assessment (PSA) score, erythema index (EI), melanin index (MI), dermatoscopic and capillaroscopic analyses of background erythema and vascular structure were assessed at baseline and one month after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Botulinum toxin will be injected into one randomly selected half of the face, and placebo will be injected into the other half of the face. The patient will not know which half of the face was treated. An independent, blinded dermatologist will evaluate the results of the treatment.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-60 years old
- •Erythematotelangiectatic rosacea subtype
- •Willingness to participate in the research and providing informed consent
排除标准
- •Patients under 18 years of age, over 60 years of age
- •A rosacea subtype other than ETR
- •History of using topical or systemic medications within the past two weeks due to rosacea or other dermatoses
- •Known history of autoimmune disease
- •History of neuromuscular disease
- •History of facial botulinum toxin injection within the last six months
- •Reporting allergy to the active ingredient
- •Pregnant or breastfeeding patients
- •Patients who do not accept treatment and follow-up
研究组 & 干预措施
Botulinum toxin A
30 points were marked on a randomly selected face half at 0.5 cm intervals. 0.5 U BoNT-A was injected into each point, making a total of 15 U BoNT-A.
干预措施: Botulinum toxin A (Drug)
Placebo
30 points were marked on a randomly selected face half at 0.5 cm intervals. 1.5 ml isotonic NaCl was injected intradermally into 30 points.
干预措施: Placebo (Drug)
结局指标
主要结局
Evaluation of erythema using mexameter
时间窗: One month
Evaluation of the effect of intradermal BoNT-A treatment on the objective erythema value measured by mexameter.
Assessment of erythema with Clinician's Erythema Assessment scale
时间窗: One month
The effect of intradermal BoNT-A treatment on facial erythema was evaluated using the Clinician's Erythema Assessment scale.
Evaluation of erythema by dermatoscopy
时间窗: One month
Evaluation of the effect of intradermal BoNT-A treatment on dermatoscopic background erythema.
次要结局
- Evaluation of the change in vascular structure using videocapillaroscopy(One month)
研究者
Buğra Burç Dağtaş
Principal Investigator
Istanbul Training and Research Hospital