Efficacy of Combined Fractional Er:Glass and Thulium Lasers Versus Microneedling for Atrophic Acne Scars

Официальное название

Randomized Controlled Trial Comparing Fractional Erbium:Glass (1540-1550 nm) and Thulium (1927 nm) Lasers Versus Microneedling for the Treatment of Atrophic Acne Scars

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Microneedling
  Microneedling performed with an electronic pen and sterile disposable cartridge with 12 needles and 2mm depth, three treatment sessions at four-week intervals.
• Устройство Fractionated Er:Glass Laser combined to Fractionated Thulium Laser
  Fractional Erbium:Glass laser will be applied first, focused on scarred areas (50 mJ, 15 ms e 100 PPA) , followed immediately by fractional Thulium 1927 nm over the full face (10 mJ, 1 ms e 100 PPA), three treatment sessions at four-week intervals.

Первичные конечные точки

• ECCA grading scale (échelle d'évaluation clinique des cicatrices d'acné) [Срок оценки: Assessments will be performed by blinded evaluators using standardized photographs at baseline.]
• ECCA grading scale (échelle d'évaluation clinique des cicatrices d'acné) [Срок оценки: Assessments will be performed by blinded evaluators using standardized photographs at 30 days after the last session.]
• ECCA grading scale (échelle d'évaluation clinique des cicatrices d'acné) [Срок оценки: Assessments will be performed by blinded evaluators using standardized photographs at 16 weeks after the last session.]

Вторичные конечные точки (12)

• Global Aesthetic Improvement Scale (GAIS) [Срок оценки: From baseline to 30 days after the end of the treatment]
• Global Aesthetic Improvement Scale (GAIS) [Срок оценки: From baseline to 16 weeks after the end of the treatment]
• Goodman & Baron Acne Scar Scale [Срок оценки: Baseline]
• Goodman & Baron Acne Scar Scale [Срок оценки: 30 days after the end of the treatment]
• Goodman & Baron Acne Scar Scale [Срок оценки: 16 weeks after the end of the treatment]
• Improvement perceived by patients [Срок оценки: 30 days after the end of the treatment]
• Satisfaction reported by patient [Срок оценки: 30 days after the end of the treatment]
• Downtime [Срок оценки: From the day after each treatment session until up to 9 days post-treatment.]
• Pain - Visual Analog Scale (VAS) [Срок оценки: Immediately after each treatment session.]
• Adverse Events [Срок оценки: Daily for 10 days after each treatment session.]
• Adverse Events [Срок оценки: Weekly until 30 days after the last treatment session.]
• Adverse Events [Срок оценки: 60 days after the last treatment session.]

Критерии участия

Критерии включения

• Fitzpatrick skin phototypes I to VI
• Presence of atrophic acne scars on the face

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• Espaço Conceito Medical San — São Paulo

Идентификаторы

NCT: NCT07151599 · ErGlass_MedicinaBiofotonica

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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