跳至主要内容
临床试验/NCT04606134
NCT04606134已完成不适用

A Single Center, Prospective, Blinded Study to Evaluate the Efficacy and Safety of a Tripeptide/Hexapeptide Topical When Used With Er:YAG Hybrid Laser for the Treatment of Acne Scars

University of Rochester2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2020年2月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Mean Change From Baseline in Erythema

研究概览

简要总结

To evaluate the efficacy of a tripeptide/hexapeptide topical (Alastin Regenerating Skin Nectar with TriHex Technology®) in wound healing and scar reduction following Erbium:YAG hybrid resurfacing laser for acne scarring compared to the standard of post-procedure care consisting of a bland moisturizer.

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 (Participant, 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

入选标准

  • male or females
  • age 18 and older
  • with evidence of grade II-III acne scars on the face (mild to moderate) as determined by the Goodman & Baron qualitative global acne scar grading system

排除标准

  • treatment to face with any energy device within 6 months
  • tanning within 7 days
  • dermabrasion or chemical peel within 3 months
  • current use of systemic retinoids
  • keloidal scaring in the treatment area
  • use of systemic steroids within 6 months
  • use of topical products with retinoid, alpha-hydroxyacid, salicylic acid, vitamin C or E within 14 days

结局指标

主要结局

Mean Change From Baseline in Erythema

时间窗: baseline to day 4

A colorimeter will be used to measure the erythema index. The range of the index is 0-99 with 0 indicating better outcome. Erythema will be measured at baseline and at follow-up visits. The mean change from baseline will be averaged to get the overall mean for each arm at each follow up visit.

次要结局

  • Number of Participants Who Scored Skin Appearance as no Change, Improved or Much Improved Using the Global Aesthetic Improvement Scale(baseline to day 90)
  • Mean Change in Skin Barrier Function(baseline to day 34)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mara Weinstein Velez, MD

Assistant Professor

University of Rochester

研究点 (2)

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