Acne ScarsNCT07151599
Efficacy of Combined Fractional Er:Glass and Thulium Lasers Versus Microneedling for Atrophic Acne Scars
A study testing Microneedling and Fractionated Er:Glass Laser combined to Fractionated Thulium Laser in people with Acne Scars, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Acne Scars
- What is being tested?
- Microneedling and Fractionated Er:Glass Laser combined to Fractionated Thulium Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteBrazil
- Study dates
- 16 Oct 2025to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Fitzpatrick skin phototypes I to VI
- Presence of atrophic acne scars on the face
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Espaço Conceito Medical San
São Paulo
Luciana C Khachikian, +5511983313093, mestrado.lucianakha@gmail.com
Luciana Camargo Khachikian
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Acne Scars
- Being tested
- Microneedling, Fractionated Er:Glass Laser combined to Fractionated Thulium Laser
- Keywords
- Fractionated Erbium Glass Laser, Fractionated Thulium Laser, Microneedling, Percutaneous Induction of Collagen, Acne Scars
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroneedlingDevice
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 LaserDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Microneedling | Active comparator | Microneedling performed with an electronic pen and sterile disposable cartridge of 12 needles at 2mm depth Receives: Device: Microneedling |
| 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. Receives: Device: Fractionated Er:Glass Laser combined to Fractionated Thulium Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: Assessments will be performed by blinded evaluators using standardized photographs at 16 weeks after the last session.
Secondary outcomes (17)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 days after the end of the treatment
Satisfaction reported by patient
Satisfaction reported by Likert scale.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 days after the end of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start16 Oct 2025
- Primary completionMay 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne ScarsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to Microneedling or Combination of Thulium and Erbium Glass Fractionated Laser in parallel.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christiane Pavani, University of Nove de Julho
- Investigators
- Christiane Pavani, PhD, Study chair, University of Nove de JulhoLuciana Khachikian, Master Student, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151599
- Sponsor's protocol ID
- ErGlass_MedicinaBiofotonica
- Status last verified
- Nov 2025
- First submitted
- 25 Aug 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All colected IPD will be shared, except individual photographs.
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07151599
- Acronym / sponsor ID
- ErGlass_MedicinaBiofotonica
- Conditions
- Acne Scars
- Keywords
- Fractionated Erbium Glass Laser, Fractionated Thulium Laser, Microneedling, Percutaneous Induction of Collagen, Acne Scars
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 16 Oct 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to Microneedling or Combination of Thulium and Erbium Glass Fractionated Laser in parallel.
| Arm | Type | Receives |
|---|---|---|
| Microneedling | Active comparator | Device: MicroneedlingMicroneedling performed with an electronic pen and sterile disposable cartridge of 12 needles at 2mm depth |
| Fractionated Er:Glass and Thulium Lasers | Experimental | Device: Fractionated Er:Glass Laser combined to Fractionated Thulium LaserFractional Erbium:Glass laser is applied first, focused on scarred areas, followed immediately by fractional Thulium 1927 nm over the full face. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Fitzpatrick skin phototypes I to VI
- Presence of atrophic acne scars on the face
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicroneedlingMicroneedling performed with an electronic pen and sterile disposable cartridge with 12 needles and 2mm depth, three treatment sessions at four-week intervals. | Device | Microneedling |
| Fractionated Er:Glass Laser combined to Fractionated Thulium LaserFractional 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. | Device | Fractionated Er:Glass and Thulium Lasers |
Primary outcome
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).
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).
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).
17 secondary outcomes
Global Aesthetic Improvement Scale (GAIS)
Time frame: From baseline to 30 days after the end of the treatment
Global Aesthetic Improvement Scale (GAIS)
Time frame: From baseline to 16 weeks after the end of the treatment
Goodman & Baron Acne Scar Scale
Time frame: Baseline
Goodman & Baron Acne Scar Scale
Time frame: 30 days after the end of the treatment
Goodman & Baron Acne Scar Scale
Time frame: 16 weeks after the end of the treatment
Improvement perceived by patients
Time frame: 30 days after the end of the treatment
Satisfaction reported by patient
Time frame: 30 days after the end of the treatment
Downtime
Time frame: From the day after each treatment session until up to 9 days post-treatment.
Pain - Visual Analog Scale (VAS)
Time frame: Immediately after each treatment session.
Adverse Events
Time frame: Daily for 10 days after each treatment session.
Adverse Events
Time frame: Weekly until 30 days after the last treatment session.
Adverse Events
Time frame: 60 days after the last treatment session.
Adverse Events
Time frame: 90 days after the last treatment session.
Facial Acne Scar Quality of Life - FASQoL
Time frame: Baseline
Facial Acne Scar Quality of Life - FASQoL
Time frame: 30 days after the end of the treatment
Dermatology Life Quality index DLQI
Time frame: Baseline
Dermatology Life Quality index DLQI
Time frame: 30 days after the end of the treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: Yes. All colected IPD will be shared, except individual photographs.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christiane Pavani, PhD study chair
University of Nove de Julho
Luciana Khachikian, Master Student principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microneedling and Fractionated Er:Glass Laser combined to Fractionated Thulium Laser in people with Acne Scars, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luciana Khachikian, Master student (+5511989969924, lucianacamargo@uni9.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.