Split-Face Comparison of 532nm Potassium Titanyl Phosphate (KTP) Laser Treatment Versus Radiofrequency Microneedling in Combination With 532 KTP Laser for Erythematotelangiectatic or Papulopustular Rosacea
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Rosacea severity measured by the Clinician's Erythema Assessment (CEA)
研究概览
简要总结
There are 3 main objectives of this proposal as follows: (1) to assess the efficacy of radiofrequency microneedling in the treatment of erythematotelangiectatic and or papulopustular rosacea, (2) to determine the potential for combination treatment of radiofrequency microneedling with the 532 nm KTP laser, and (3) identify potential novel therapeutic strategies for the treatment of rosacea.
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
- 否
入选标准
- •Male or female adult (>18yo) subjects in general good health
- •Clinical and/or histologic diagnosis of erythematotelangiectatic or papulopustular rosacea.
- •Subject is able to understand and sign informed consent
- •Subject is able to complete the study and comply with study procedures
排除标准
- •Patients currently utilizing oxymetazoline or brimonidine.
- •Presence of dermatoses that might interfere with diagnosis as determined by a study investigator
- •Presence of extreme light sensitivity, or conditions pre-disposing to light sensitivity such as but not limited to xeroderma pigmentosum
- •Any significant medical condition that may prevent the patient from participating in the study according to the investigator's assessment
- •History of poor wound healing or blood-clotting abnormality
- •History of keloid formation or hypertrophic scarring
- •Hypersensitivity or contraindication to local anesthetics as determined by the principal investigator or other medical professional.
研究组 & 干预措施
Potassium titanyl phosphate (KTP) Laser Therapy with unilateral Radiofrequency Microneedling
Participants will be in this group for up to 36 weeks
干预措施: KTP Laser Therapy (Device)
Potassium titanyl phosphate (KTP) Laser Therapy with unilateral Radiofrequency Microneedling
Participants will be in this group for up to 36 weeks
干预措施: Radiofrequency microneedling (Device)
结局指标
主要结局
Change in Rosacea severity measured by the Clinician's Erythema Assessment (CEA)
时间窗: Baseline, up to 16 weeks after the last treatment
Score range from 0 (clear skin) to 4 (severe erythema). Lower scores indicate less rosacea severity as assessed by the CEA scale.
次要结局
- Change in Patient reported impact on quality of life (QOL) measured by DLQI(Baseline, up to 16 weeks after the last treatment)
- Change in patient satisfaction with treatment outcomes measured by Patient Self-Assessment (PSA)(Baseline, up to 16 weeks after the last treatment)
- Change in Global Aesthetic Improvement scale (GAIS)(Baseline, up to 16 weeks after the last treatment)
- Proportion of blinded photo assessment(Baseline, up to 16 weeks after the last treatment)
研究者
Ariel Eva Eber
Assistant Professor
University of Miami