A Pilot, Split-Face Randomized, Evaluator Blinded Study on the Effectiveness of a Bipolar Fractional Radiofrequency System Versus 1550-nm Fractional Photothermolysis for the Treatment of Acne Scars.
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change in best overall cosmetic appearance (right side or left side better)rated by a blinded dermatologist from baseline to week 16
研究概览
简要总结
The purpose of this study is to compare the effectiveness of the ePrime fractional radiofrequency system to the 1550-nm fractional photothermolysis system (Fraxel) in the ability to improve acne scar appearance.
详细描述
Participants in this study will be patients at the dermatology clinic with icepick and boxcar acne scars on at least one 2 x 2 cm area on each side of face. Subjects will be randomly assigned to receive fractional radiofrequency treatment to either the right or left side of the face and the contralateral side will receive 1550-nm fractional photothermolysis. Subjects will receive treatments at baseline, week 4, and week 8 for a total of three treatments. Follow up visits will take place at week 16, two months following the last treatment visit. This study is a pilot study designed to determine feasibility of these procedures.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects age 18 years and older.
- •Subjects with bilateral 2x2 cm areas of ice pick and/or boxcar acne scars on their face.
- •Subjects are in good health.
- •Subjects have the willingness and the ability to understand and provide informed consent and communicate with the investigator.
排除标准
- •Subjects who have received injectable soft-tissue augmentation materials to the face, or facial ablative resurfacing, within the past 6 months.
- •Subjects who have received injectable botulinum toxin to the face, or any nonablative laser treatment to the face, within the past 3 months.
- •Subjects who have local infections, open facial wounds, or other significant local skin disease that would interfere with acne scar treatment with energy devices.
- •Subjects who are allergic to lidocaine or prilocaine.
- •Subjects who have a history of abnormal scarring in the treatment area, such as keloid scar formation.
- •Subjects who have ectropion or or other eyelid disfigurement.
- •Subjects who have a history of isotretinoin use in the preceding year.
- •Pregnant or lactating individuals.
研究组 & 干预措施
Fractional Radiofrequency
Subjects will be randomly assigned to receive fractional radiofrequency treatment to either the right or left side of the face and the contralateral side will receive 1550-nm fractional photothermolysis. Subjects will receive treatments at baseline, week 4, and week 8 for a total of three treatments. Follow up visits will take place at week 16, two months following the last treatment visit.
干预措施: Fractional Radiofrequency (Device)
1550-nm Fractional Photothermolysis
Subjects will be randomly assigned to receive fractional radiofrequency treatment to either the right or left side of the face and the contralateral side will receive 1550-nm fractional photothermolysis. Subjects will receive treatments at baseline, week 4, and week 8 for a total of three treatments. Follow up visits will take place at week 16, two months following the last treatment visit.
干预措施: 1550-nm Fractional Photothermolysis (Device)
结局指标
主要结局
Change in best overall cosmetic appearance (right side or left side better)rated by a blinded dermatologist from baseline to week 16
时间窗: 1 hour at baseline and week 16
The primary outcome was a blinded rating of the treatment area (Fractional Radiofrequency Versus Fractional Photothermolysis) with the best cosmetic appearance. A dermatologist will blindly evaluate the treated areas of each side from live subjects at baseline and on the final follow up visit (week 16).
次要结局
未报告次要终点
研究者
Murad Alam
Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation
Northwestern University