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
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
- 否
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
Mara Weinstein Velez, MD
Assistant Professor
University of Rochester
