An interventional study of Microneedling and Fractionated Er:Glass Laser combined to Fractionated Thulium Laser in Acne Scars, sponsored by University of Nove de Julho. Recruiting at 1 site in Brazil. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-11-26.
Sponsored by University of Nove de Julho · Not applicable, Interventional, and Treatment
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.
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.
University of Nove de Julho is the lead sponsor of 239 studies on the registry; 51 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 1 (13%) have results posted.
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Exclusion Criteria:
Microneedling performed with an electronic pen and sterile disposable cartridge of 12 needles at 2mm depth
Device: Microneedling
Fractional Erbium:Glass laser is applied first, focused on scarred areas, followed immediately by fractional Thulium 1927 nm over the full face.
Device: Fractionated Er:Glass Laser combined to Fractionated Thulium Laser
Microneedling performed with an electronic pen and sterile disposable cartridge with 12 needles and 2mm depth, three treatment sessions at four-week intervals.
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.
ECCA grading scale (échelle d'évaluation clinique des cicatrices d'acné)
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).
Time frame: Assessments will be performed by blinded evaluators using standardized photographs at baseline.
ECCA grading scale (échelle d'évaluation clinique des cicatrices d'acné)
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).
Time frame: 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)
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).
Time frame: Assessments will be performed by blinded evaluators using standardized photographs at 16 weeks after the last session.
Global Aesthetic Improvement Scale (GAIS)
Blinded evaluators will perform side-by-side comparisons of baseline vs. 30-day photographs. Improvement will be graded on a 5-point ordinal scale.
Time frame: From baseline to 30 days after the end of the treatment
Global Aesthetic Improvement Scale (GAIS)
Blinded evaluators will perform side-by-side comparisons of baseline vs. 16 weeks photographs. Improvement will be graded on a 5-point ordinal scale.
Time frame: From baseline to 16 weeks after the end of the treatment
Goodman & Baron Acne Scar Scale
Scars will be categorized according to morphology, recording the number of mild, moderate, severe, and hypertrophic lesions. An algorithm will generate a total score (range: 0-84), with higher scores indicating greater severity and number of scars. This scoring system reflects both the type and frequency of lesions, with higher values representing worse scar severity.
Time frame: Baseline
Goodman & Baron Acne Scar Scale
Scars will be categorized according to morphology, recording the number of mild, moderate, severe, and hypertrophic lesions. An algorithm will generate a total score (range: 0-84), with higher scores indicating greater severity and number of scars. This scoring system reflects both the type and frequency of lesions, with higher values representing worse scar severity.
Time frame: 30 days after the end of the treatment
Goodman & Baron Acne Scar Scale
Scars will be categorized according to morphology, recording the number of mild, moderate, severe, and hypertrophic lesions. An algorithm will generate a total score (range: 0-84), with higher scores indicating greater severity and number of scars. This scoring system reflects both the type and frequency of lesions, with higher values representing worse scar severity.
Time frame: 16 weeks after the end of the treatment
Improvement perceived by patients
articipants will self-assess their improvement using a quartile grading scale. This measure captures the subjective satisfaction of the participant and complements the blinded clinical assessments.
Time frame: 30 days after the end of the treatment
Satisfaction reported by patient
Satisfaction reported by Likert scale.
Time frame: 30 days after the end of the treatment
Downtime
Recovery time will be recorded in days and defined as the period in which the participant experiences visible clinical signs (such as erythema or edema) and local discomfort (burning, pain, or itching), leading to physical or aesthetic limitations. Participants will complete a standardized daily questionnaire, administered via telephone contact by the study investigator, to report the presence of symptoms and whether they avoided public activities due to skin appearance. This outcome aims to quantify, in a subjective and functional way, the short-term impact of treatment on quality of life, social activities, and overall tolerability.
Time frame: From the day after each treatment session until up to 9 days post-treatment.
Pain - Visual Analog Scale (VAS)
Pain will be assessed using the Visual Analog Scale (VAS), a 10-cm straight line where 0 represents "no pain" and 10 represents "worst possible pain." Immediately after each session, participants will be asked to mark the point on the line that best represents the pain experienced during the procedure.
Time frame: Immediately after each treatment session.
Adverse Events
Participants will be contacted daily via WhatsApp message or phone call to report the presence or absence of adverse events, including pain, erythema, edema, infection, discharge, crusts, hyperpigmentation, or scarring.
Time frame: Daily for 10 days after each treatment session.
Adverse Events
Participants will be contacted daily via WhatsApp message or phone call to report the presence or absence of adverse events, including pain, erythema, edema, infection, discharge, crusts, hyperpigmentation, or scarring.
Time frame: Weekly until 30 days after the last treatment session.
Adverse Events
Participants will be contacted daily via WhatsApp message or phone call to report the presence or absence of adverse events, including pain, erythema, edema, infection, discharge, crusts, hyperpigmentation, or scarring.
Time frame: 60 days after the last treatment session.
Adverse Events
Participants will be contacted daily via WhatsApp message or phone call to report the presence or absence of adverse events, including pain, erythema, edema, infection, discharge, crusts, hyperpigmentation, or scarring.
Time frame: 90 days after the last treatment session.
Facial Acne Scar Quality of Life - FASQoL
A ten questions instrument, presenting 5 answers for each question, giving 0-4 points. A total of 0-40 points will be find, being higher the higest impact in quality of life.
Time frame: Baseline
Facial Acne Scar Quality of Life - FASQoL
A ten questions instrument, presenting 5 answers for each question, giving 0-4 points. A total of 0-40 points will be find, being higher the higest impact in quality of life.
Time frame: 30 days after the end of the treatment
Dermatology Life Quality index DLQI
The Dermatology Life Quality Index (DLQI) is a 10-question, self-administered questionnaire for adults (16+) to measure the impact of skin disease on their daily lives over the past week.
Time frame: Baseline
Dermatology Life Quality index DLQI
The Dermatology Life Quality Index (DLQI) is a 10-question, self-administered questionnaire for adults (16+) to measure the impact of skin disease on their daily lives over the past week.
Time frame: 30 days after the end of the treatment
Plan to share: Yes — All colected IPD will be shared, except individual photographs.
Supporting information: Sap
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