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NCT Number: NCT07151599

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

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.

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Key information

Conditions

Acne Scars

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Espaço Conceito Medical San

São Paulo, Brazil

Location status: Recruiting

Location contact

Luciana C Khachikian

CONTACT

[email protected]

+5511983313093

Luciana Camargo Khachikian

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)

Treatment and study plan

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.

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.

Primary outcomes

  1. ECCA grading scale (échelle d'évaluation clinique des cicatrices d'acné)

    Time frame: 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).

  2. ECCA grading scale (échelle d'évaluation clinique des cicatrices d'acné)

    Time frame: 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).

  3. ECCA grading scale (échelle d'évaluation clinique des cicatrices d'acné)

    Time frame: 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).

Secondary outcomes

  1. Global Aesthetic Improvement Scale (GAIS)

    Time frame: From baseline to 30 days after the end of the treatment

    Blinded evaluators will perform side-by-side comparisons of baseline vs. 30-day photographs. Improvement will be graded on a 5-point ordinal scale.

  2. Global Aesthetic Improvement Scale (GAIS)

    Time frame: From baseline to 16 weeks after the end of the treatment

    Blinded evaluators will perform side-by-side comparisons of baseline vs. 16 weeks photographs. Improvement will be graded on a 5-point ordinal scale.

  3. Goodman & Baron Acne Scar Scale

    Time frame: Baseline

    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.

  4. Goodman & Baron Acne Scar Scale

    Time frame: 30 days after the end of the treatment

    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.

  5. Goodman & Baron Acne Scar Scale

    Time frame: 16 weeks after the end of the treatment

    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.

  6. Improvement perceived by patients

    Time frame: 30 days after the end of the treatment

    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.

  7. Satisfaction reported by patient

    Time frame: 30 days after the end of the treatment

    Satisfaction reported by Likert scale.

  8. Downtime

    Time frame: From the day after each treatment session until up to 9 days post-treatment.

    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.

  9. Pain - Visual Analog Scale (VAS)

    Time frame: Immediately after each treatment session.

    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.

  10. Adverse Events

    Time frame: Daily for 10 days after each treatment session.

    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.

  11. Adverse Events

    Time frame: Weekly until 30 days after the last treatment session.

    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.

  12. Adverse Events

    Time frame: 60 days after the last treatment session.

    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.

  13. Adverse Events

    Time frame: 90 days after the last treatment session.

    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.

  14. Facial Acne Scar Quality of Life - FASQoL

    Time frame: Baseline

    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.

  15. Facial Acne Scar Quality of Life - FASQoL

    Time frame: 30 days after the end of the treatment

    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.

  16. Dermatology Life Quality index DLQI

    Time frame: Baseline

    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.

  17. Dermatology Life Quality index DLQI

    Time frame: 30 days after the end of the treatment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Luciana Khachikian, Master student

CONTACT

[email protected]

+5511989969924

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 3, 2025
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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