Split-Face Comparison of Vacuum Hydroabrasion-Jet System Versus Conventional High-Pressure Jet Peel System for Facial Rejuvenation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Change in Facial Skin Hydration From Baseline to T3
研究概览
简要总结
This study compared the effects and tolerability of two non-invasive facial treatment systems on skin hydration: a hydroabrasion-jet system (KIRA) and a conventional high-pressure jet system (JET PEEL). Twenty-three women aged 30-65 years underwent three treatment sessions in an intraindividual split-face design, with KIRA applied to the left side of the face and JET PEEL to the right side. Skin hydration was assessed by corneometry at baseline, 48 hours after the first treatment, before the second treatment, and before the third treatment; the measurement before the third treatment was the primary endpoint. Additional exploratory assessments included multispectral skin imaging, participant-reported treatment experience and preference, and a 21-day follow-up. The study evaluated differences in hydration outcomes between a protocol combining vacuum-assisted hydroabrasion with 5-bar jet infusion and a conventional high-pressure jet treatment at 6.89 bar.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors performing the instrumental skin measurements were independent from the treatment procedure and were unaware whether participants had undergone treatment and which intervention had been applied to each side of the face.
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female participants aged 30-65 years
- •Fitzpatrick skin types II-III
- •Presence of signs of facial skin aging, including one or more of the following: hyperkeratosis, hyperpigmentation, facial or age-related wrinkles, and enlarged pores
- •Generally healthy and without contraindications to the study procedures
- •Willing and able to provide informed consent and participate in the study procedures
排除标准
- •Pregnancy or breastfeeding
- •Serious vascular disorders
- •Pacemaker or metal implants in the treatment area
- •Malignant skin disease
- •Autoimmune or endocrine disease, diabetes, or acquired immunodeficiency syndrome
- •Psoriasis, herpes, or other active skin disease
- •Infection in the treatment area
- •Tendency toward keloid scarring or allergic reactions
- •Long-term corticosteroid therapy or other medication considered incompatible with the procedures
- •Hyaluronic acid filler or botulinum toxin injections in the treatment area
- •Tattoo or permanent makeup in the treatment area
- •Invasive aesthetic procedures within the previous 5 months
- •Failure to meet the inclusion criteria
研究组 & 干预措施
Arm 2: JET PEEL Treatment - Right Facial Side
Participants received treatment with the JET PEEL system on the right facial side. The protocol consisted of jet-based treatment and infusion at 6.89 bar. Three treatment sessions were performed according to the study protocol.
干预措施: High-Pressure Jet Infusion (Device)
Arm 1: KIRA Treatment - Left Facial Side
Participants received treatment with the KIRA hydroabrasion-jet system on the left facial side. The protocol consisted of vacuum-assisted hydroabrasion for epidermal preparation followed by 5-bar jet infusion. Three treatment sessions were performed according to the study protocol.
干预措施: Vacuum-Assisted Hydroabrasion (Device)
Arm 1: KIRA Treatment - Left Facial Side
Participants received treatment with the KIRA hydroabrasion-jet system on the left facial side. The protocol consisted of vacuum-assisted hydroabrasion for epidermal preparation followed by 5-bar jet infusion. Three treatment sessions were performed according to the study protocol.
干预措施: Jet Infusion at 5 Bar (Device)
结局指标
主要结局
Change in Facial Skin Hydration From Baseline to T3
时间窗: Baseline (T0) to before the third treatment session (T3; approximately 14 days)
Facial skin hydration was measured separately on the KIRA-treated and JET PEEL-treated facial sides using corneometry. The primary outcome was the change in corneometer-measured skin hydration, expressed in arbitrary units (a.u.), from baseline (T0) to T3, measured before the third treatment session. The within-participant difference in change between the two facial sides was used for the primary comparison.
Change in Facial Skin Hydration From Baseline to Before the Third Treatment Session
时间窗: Baseline (T0) to before the third treatment session (T3; approximately 14 days)
Facial skin hydration was measured separately on the KIRA-treated and JET PEEL-treated facial sides using corneometry. The primary outcome was the change in corneometer-measured skin hydration, expressed in arbitrary units (a.u.), from baseline (T0) to the measurement before the third treatment session (T3). The within-participant difference in change between the two facial sides was used for the primary comparison.
次要结局
未报告次要终点
研究者
Katarina Obradović
Principal Investigator
Faculty of Pharmacy Novi Sad