Comparison of Clinical Outcome Parameters, the Patient Benefit Index (PBI) and Patient Satisfaction After Ablative Fractional Laser Treatment of Peri-orbital Rhytides
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Quantitative measurement of wrinkle depth
研究概览
简要总结
We previously published a comparative split-face study which has shown a significant, albeit moderate, effect of ablative fractional laser treatment. While indicating that a single session with fractional ablative lasers can be effective in the treatment of peri-orbital wrinkles, the trial also revealed substantial disagreement between the different end points (profilometry, Fitzpatrick wrinkle score, patient satisfaction). Since the PBI is a patient-related index it could not be included in the aforementioned split-face trial; the present study therefore attempts to further elucidate the patient-related benefit of a single fractional ablative laser treatment session as well as carefully analyse the respective correlations between the outcome parameters employed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •mild to moderate peri-orbital rhytides ('crow's feet') at rest (Class II according to Fitzpatrick)
排除标准
- •unrealistic expectations
- •inability to meet follow-up criteria
- •Fitzpatrick skin phototype >III
- •coagulation disorders or anti-coagulant treatment
- •allergy to lidocaine or tetracaine
- •oral isotretinoin within the last 6 months
- •any active skin disease within the treatment areas (e.g., psoriasis, cancer, or autoimmune disease)
- •synthetic implants in the treatment area
- •facial cosmetic procedures affecting the treatment area within the last 6 months
- •photosensitizing medications (e.g., tetracycline, gold)
- •history of keloid formation
- •pregnancy
结局指标
主要结局
Quantitative measurement of wrinkle depth
时间窗: Before and after treatment (3 months)
Fitzpatrick wrinkle score
时间窗: Before and after treatment (3 months)
次要结局
- Patient benefit index (PBI)(Before and after treatment (3 months))
- Patient satisfaction(1, 3, 6 days and 3 months after treatment)