Efficacy of Combined 1927nm Thulium Fiber Laser and Supramolecular Salicylic Acid in Photoaging Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- photodamage score
研究概览
简要总结
Purpose: 1927nm fractional thulium fiber laser (TFL) has been shown to be effective in improving skin appearance by reducing pigmentation and loss of elasticity caused by photoaging. Supramolecular salicylic acid (SSA) has been utilized for chemical peeling with rejuvenation effect. This study aims to evaluate the effectiveness and safety of combined TFL and SSA treatment for photoaging.
Methods: Thirty-six patients with moderate-to-severe photoaging were enrolled and the two sides of the participants' face were randomly assigned to receive 30% SSA combined with TFL or TFL monotherapy. TFL was administered to both sides of the face on four occasions at four-week intervals, while the side receiving combined treatment additionally underwent eight chemical peels of 30% SSA fortnightly, supplemented by daily applications of 2% SSA. For the TFL-alone side, an equivalent dose of a placebo preparation was applied. The photographs, photoaging scores, melanin index (MI), erythema index (EI), skin hydration, trans-epidermal water loss (TEWL), dermal thickness, elasticity index, and skin rebound time were assessed.
详细描述
This prospective, split-face, randomized, double-blind clinical trial evaluated the efficacy of fractional thulium fiber laser (TFL) monotherapy versus TFL combined with topical succinic acid (SSA) for photoaging treatment. Eligible participants (aged 40-70 years) with symmetric facial photodamage and a modified photoaging scale score >11 were enrolled, excluding individuals with systemic diseases, skin pathologies, recent aesthetic treatments, or SSA allergies. Following ethical approval (MR-61-23-03452; 2023019) and informed consent, subjects underwent four TFL sessions (1927 nm, 8-10 mJ, 10 W, 0.8 mm spacing) at 4-week intervals. Post-TFL, one randomized facial side received 30% SSA (or placebo, biweekly) and 2% SSA (or vehicle, daily) for 16 weeks, with allocation blinded to participants and investigators. Interventions were standardized using a clinical endpoint of mild erythema/epidermal whitening, followed by saline rinsing and medical mask application. Preprocedural anesthesia with compound lidocaine cream and postoperative protocols (ice packs for adverse events, medical masks, sun protection, and delayed cleansing until scab detachment) were implemented. Adverse events and adherence to post-treatment care were monitored. The study adhered to Declaration of Helsinki principles, with anonymized data analysis and oversight by the ethics committee of the Second Affiliated Hospital of Xi'an Jiao Tong University.
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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled patients were scored using the Modified Photodamage Scale (total score of 16), and subjects with a score greater than 11 were ultimately included (less than 4, mild; up to 4-8, moderate; up to 8-12, advanced; and greater than 12, severe photodamage).
- •Exclusion Criteria
- •Severe systemic disease
- •Skin tumours or infections
- •Currently pregnant or breastfeeding
- •Recent use (within the last 6 months) of oral or topical medications or phototherapy, laser, filler or botulinum toxin treatment
- •Allergy to SA
- •A history of keloid scarring.
排除标准
- 未提供
研究组 & 干预措施
TFL-only group
TFL Alone Treatment Side (Control/Placebo Side) Interventions:
Pre-TFL Preparation:
Topical application of Compound Lidocaine Cream (30-40 minutes) for anesthesia.Facial sterilization with alcohol.
TFL Treatment:
Half-face treatment with a 1927 nm fractional thulium fiber laser (WONTECH, Lavieen, South Korea).
Parameters: Pulse energy 8-10 mJ, output power 10 W, pulse spacing 0.8 mm. Post-TFL Intervention:Immediate application of placebo (base material of 30% SSA) on the assigned facial side after TFL.Placebo gently massaged with saline for penetration simulation.
Placebo maintained until clinical endpoint (mild erythema/whitening), followed by saline rinse and a 20-minute medical repair mask.
Adjunctive Regimen (16 Weeks):
Placebo applied biweekly (matching 30% SSA frequency) and daily (matching 2% SSA regimen).
干预措施: 1927nm fractional thulium fiber laser(TFL) (Device)
PFL-SSA combination treatment group
TFL-SSA Combination Therapy Side (Intervention Side) Interventions:
Pre-TFL Preparation:
Identical to the control side: Lidocaine Cream and alcohol sterilization.
TFL Treatment:
Same laser parameters and half-face coverage as the control side.
Post-TFL Intervention:
Immediate application of 30% SSA on the assigned facial side after TFL. SSA gently massaged with saline to enhance penetration. SSA maintained until clinical endpoint (erythema/whitening), followed by saline rinse and a 20-minute medical repair mask.
Adjunctive Regimen (16 Weeks):
30% SSA applied biweekly and 2% SSA applied daily to the combination therapy side.
干预措施: 1927nm fractional thulium fiber laser(TFL) (Device)
PFL-SSA combination treatment group
TFL-SSA Combination Therapy Side (Intervention Side) Interventions:
Pre-TFL Preparation:
Identical to the control side: Lidocaine Cream and alcohol sterilization.
TFL Treatment:
Same laser parameters and half-face coverage as the control side.
Post-TFL Intervention:
Immediate application of 30% SSA on the assigned facial side after TFL. SSA gently massaged with saline to enhance penetration. SSA maintained until clinical endpoint (erythema/whitening), followed by saline rinse and a 20-minute medical repair mask.
Adjunctive Regimen (16 Weeks):
30% SSA applied biweekly and 2% SSA applied daily to the combination therapy side.
干预措施: supramolecular salicylic acid(SSA) (Drug)
结局指标
主要结局
photodamage score
时间窗: From enrollment to the end of treatment at 16 weeks
Efficacy of photoaging improvement was assessed by the formula: ((Baseline photodamage score - Post-treatment photodamage score) / Baseline photodamage score) x 100%.All patients were photographed using a standardized digital camera (EOS 600D, Canon, Tokyo, Japan) under identical lighting conditions at each visit.Assessments were conducted at at weeks 0 (baseline), 4, 8, 12, and 16, ensuring consistent lighting and positioning. Photoaging scores were determined by three independent blinded dermatologists, utilizing a digital picture-contrast scale for grading. Distinct weighting factors were allocated to various photoaging characteristics. Photoaging scores were performed using a standardized scale named Photoaging Scale.And Photoaging score has a maximum value of 16 and a minimum value of 0.Lower photoaging scores mean more significant improvements after intervention.
次要结局
- Melanin Index(Assessments were conducted at at weeks 0 (baseline), 4, 8, 12, and 16.)
- Transepidermal Water Loss(Assessments were conducted at at weeks 0 (baseline), 4, 8, 12, and 16.)
- dermal thickness(Assessments were conducted at at weeks 0 (baseline), 4, 8, 12, and 16.)
- Erythema Index(Assessments were conducted at at weeks 0 (baseline), 4, 8, 12, and 16.)
- skin hydration(Assessments were conducted at at weeks 0 (baseline), 4, 8, 12, and 16.)
- elasticity index(Assessments were conducted at at weeks 0 (baseline), 4, 8, 12, and 16.)
研究者
Weihui Zeng
Professor
Second Affiliated Hospital of Xi'an Jiaotong University