Acne Scars
Conditions
Keywords
Fractionated Erbium Glass Laser, Fractionated Thulium Laser, Microneedling, Percutaneous Induction of Collagen, Acne Scars
Brief 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.
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.
Interventions
DEVICEMicroneedling
Microneedling performed with an electronic pen and sterile disposable cartridge with 12 needles and 2mm depth, three treatment sessions at four-week intervals.
DEVICEFractionated 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.
Sponsors
University of Nove de Julho
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
Participants are assigned to Microneedling or Combination of Thulium and Erbium Glass Fractionated Laser in parallel.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ECCA grading scale (échelle d'évaluation clinique des cicatrices d'acné) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Goodman & Baron Acne Scar Scale | 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. |
| Improvement perceived by patients | 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. |
| Satisfaction reported by patient | 30 days after the end of the treatment | Satisfaction reported by Likert scale. |
| Downtime | 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. |
| Global Aesthetic Improvement Scale (GAIS) | 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. |
| Adverse Events | 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. |
| Facial Acne Scar Quality of Life - FASQoL | 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. |
| Dermatology Life Quality index DLQI | 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. |
| Pain - Visual Analog Scale (VAS) | 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. |
Countries
Brazil
Contacts
Primary ContactLuciana Khachikian, Master student
Outcome results
None listed