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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microneedling | Active Comparator | Microneedling performed with an electronic pen and sterile disposable cartridge of 12 needles at 2mm depth |
|
| Fractionated Er:Glass and Thulium Lasers | Experimental | Fractional Erbium:Glass laser is applied first, focused on scarred areas, followed immediately by fractional Thulium 1927 nm over the full face. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microneedling | Device | Microneedling performed with an electronic pen and sterile disposable cartridge with 12 needles and 2mm depth, three treatment sessions at four-week intervals. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to 30 days after the end of the treatment |
| Global Aesthetic Improvement Scale (GAIS) |
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Inclusion Criteria:
Exclusion Criteria:
cisgender women and cisgender men
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luciana Khachikian, Master student | Contact | +5511989969924 | lucianacamargo@uni9.edu.br |
| Name | Affiliation | Role |
|---|---|---|
| Christiane Pavani, PhD | University of Nove de Julho | Study Chair |
| Luciana Khachikian, Master Student | University of Nove de Julho | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Espaço Conceito Medical San | Recruiting | São Paulo | Brazil |
All colected IPD will be shared, except individual photographs.
The IPD will be available after the publication of the results, for 10 years.
The IPD will be available as a excel file.
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| ID | Term |
|---|---|
| D000097244 | Percutaneous Collagen Induction |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D011677 | Punctures |
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Participants are assigned to Microneedling or Combination of Thulium and Erbium Glass Fractionated Laser in parallel.
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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.
| Fractionated Er:Glass Laser combined to Fractionated Thulium Laser | Device | 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. |
|
| Assessments will be performed by blinded evaluators using standardized photographs at 16 weeks after the last session. |
Blinded evaluators will perform side-by-side comparisons of baseline vs. 16 weeks photographs. Improvement will be graded on a 5-point ordinal scale. |
| 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. | 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. | 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. | 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. | 30 days after the end of the treatment |
| Satisfaction reported by patient | Satisfaction reported by Likert scale. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 30 days after the end of the treatment |
| D012046 |
| Rehabilitation |