Randomized Controlled Trial Comparing Fractional Erbium:Glass (1540-1550 nm) and Thulium (1927 nm) Lasers Versus Microneedling for the Treatment of Atrophic Acne Scars
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- ECCA grading scale (échelle d'évaluation clinique des cicatrices d'acné)
研究概览
简要总结
The purpose of this study is to compare two treatments for acne scars on the face. The study will test whether fractional lasers (Erbium:Glass and Thulium) lead to better improvement in acne scars than microneedling.
详细描述
Acne scars are common and can have a lasting impact on self-esteem, social relationships, and quality of life. Several treatment options exist, but many patients continue to seek better results. Microneedling is a minimally invasive technique that uses small needles to stimulate skin repair. Fractional lasers, such as Erbium:Glass (1540-1550 nm) and Thulium (1927 nm), deliver energy into the skin to promote remodeling of deeper and more superficial layers. The combination of these two fractional lasers may provide a more comprehensive treatment approach for acne scars.
This clinical trial will directly compare these two options: microneedling versus the combined use of fractional Erbium:Glass and Thulium lasers. A total of 84 adults between 18 and 30 years old with atrophic acne scars will take part. Participants will be randomly chosen by a draw (like a lottery) to receive one of the two groups. Both groups will receive three treatment sessions, with four weeks between each session.
The main goal is to determine which treatment leads to greater improvement in acne scars. Improvement will be measured by independent evaluators who will compare standardized before-and-after photographs using a grading scale. Participants will also report their own satisfaction with the results and how well they tolerated the treatments. Follow-up assessments will occur up to 90 days after the last session.
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
- Single (Outcomes Assessor)
盲法说明
Assesor evaluation of the outcomes will be performed in anonymous pictures. The participant reported outcomes will not be blinded, since participant will not be masked.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fitzpatrick skin phototypes I to VI
- •Presence of atrophic acne scars on the face
排除标准
- •Decompensated systemic diseases
- •Any active infection (e.g., viral such as herpes, bacterial, or fungal)
- •Pregnant or breastfeeding women
- •Presence of hypertrophic or keloid scars
- •Current use of anticoagulant or antiplatelet medications
- •History of hemophilia or coagulation disorders
- •Current use of anti-inflammatory drugs or corticosteroids
- •Use of retinoids, including isotretinoin, within the past 6 months
- •Exposure to sunlight within the past 15 days
- •Undergoing any aesthetic facial treatment or having undergone scar treatments in the facial region within 180 days prior to study initiation
- •Presence of active acne (occasional isolated lesions will not be considered exclusion criteria)
研究组 & 干预措施
Microneedling
Microneedling performed with an electronic pen and sterile disposable cartridge of 12 needles at 2mm depth
干预措施: Microneedling (Device)
Fractionated Er:Glass and Thulium Lasers
Fractional Erbium:Glass laser is applied first, focused on scarred areas, followed immediately by fractional Thulium 1927 nm over the full face.
干预措施: Fractionated Er:Glass Laser combined to Fractionated Thulium Laser (Device)
结局指标
主要结局
ECCA grading scale (échelle d'évaluation clinique des cicatrices d'acné)
时间窗: Assessments will be performed by blinded evaluators using standardized photographs at 16 weeks after the last session.
The ECCA is a validated scale that quantifies acne scars through both qualitative and quantitative components. Scar type is weighted by a numerical factor (15-30 for atrophic scars and elastosis; 40-50 for hypertrophic/keloid scars) and multiplied by the number of lesions, graded on a 4-point scale: 0 = none; 1 = \<5 scars; 2 = 5-20 scars; 3 = \>20 scars. The global score ranges from 0 to 540, with higher scores indicating greater severity. In this study, participants with hypertrophic or keloid scars will be excluded; therefore, only atrophic scar subtypes will be scored (subcategory 1).
ECCA grading scale (échelle d'évaluation clinique des cicatrices d'acné)
时间窗: Assessments will be performed by blinded evaluators using standardized photographs at baseline.
The ECCA is a validated scale that quantifies acne scars through both qualitative and quantitative components. Scar type is weighted by a numerical factor (15-30 for atrophic scars and elastosis; 40-50 for hypertrophic/keloid scars) and multiplied by the number of lesions, graded on a 4-point scale: 0 = none; 1 = \<5 scars; 2 = 5-20 scars; 3 = \>20 scars. The global score ranges from 0 to 540, with higher scores indicating greater severity. In this study, participants with hypertrophic or keloid scars will be excluded; therefore, only atrophic scar subtypes will be scored (subcategory 1).
ECCA grading scale (échelle d'évaluation clinique des cicatrices d'acné)
时间窗: Assessments will be performed by blinded evaluators using standardized photographs at 30 days after the last session.
The ECCA is a validated scale that quantifies acne scars through both qualitative and quantitative components. Scar type is weighted by a numerical factor (15-30 for atrophic scars and elastosis; 40-50 for hypertrophic/keloid scars) and multiplied by the number of lesions, graded on a 4-point scale: 0 = none; 1 = \<5 scars; 2 = 5-20 scars; 3 = \>20 scars. The global score ranges from 0 to 540, with higher scores indicating greater severity. In this study, participants with hypertrophic or keloid scars will be excluded; therefore, only atrophic scar subtypes will be scored (subcategory 1).
次要结局
- Global Aesthetic Improvement Scale (GAIS)(From baseline to 16 weeks after the end of the treatment)
- Goodman & Baron Acne Scar Scale(16 weeks after the end of the treatment)
- Improvement perceived by patients(30 days after the end of the treatment)
- Satisfaction reported by patient(30 days after the end of the treatment)
- Downtime(From the day after each treatment session until up to 9 days post-treatment.)
- Pain - Visual Analog Scale (VAS)(Immediately after each treatment session.)
- Adverse Events(90 days after the last treatment session.)
- Facial Acne Scar Quality of Life - FASQoL(30 days after the end of the treatment)
- Dermatology Life Quality index DLQI(30 days after the end of the treatment)
- Global Aesthetic Improvement Scale (GAIS)(From baseline to 30 days after the end of the treatment)
- Goodman & Baron Acne Scar Scale(Baseline)
- Goodman & Baron Acne Scar Scale(30 days after the end of the treatment)
- Adverse Events(Daily for 10 days after each treatment session.)
- Adverse Events(Weekly until 30 days after the last treatment session.)
- Adverse Events(60 days after the last treatment session.)
- Facial Acne Scar Quality of Life - FASQoL(Baseline)
- Dermatology Life Quality index DLQI(Baseline)
研究者
Christiane Pavani
Randomized Controlled Trial Comparing Combined Fractional Erbium:Glass and Thulium Lasers Versus Microneedling for the Treatment of Atrophic Acne Scars
University of Nove de Julho