Clinical Trials in Brazil / NCT07151599
Recruiting
Not applicable
Efficacy of Combined Fractional Er:Glass and Thulium Lasers Versus Microneedling for Atrophic Acne Scars
NCT07151599 · tracked via the Priya Life Science Brazil tracker
Condition(s) studied
Acne Scars
Investigational drug(s) / intervention(s)
MicroneedlingFractionated Er:Glass Laser combined to Fractionated Thulium Laser
Microneedling: 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: 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 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.
Eligibility
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)
Primary outcome measure(s)
- 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). - ECCA grading scale (échelle d'évaluation clinique des cicatrices d'acné) — 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) — 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).
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Espaço Conceito Medical San | São Paulo | Brazil | Recruiting |
More University of Nove de Julho trials in Brazil
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07151599 on ClinicalTrials.gov ↗ ← All trials in Brazil