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

ConditionAcne Scars
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorUniversity of Nove de Julho

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Fitzpatrick skin phototypes I to VI

Presence of atrophic acne scars on the face

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: MicroneedlingActive comparator 1 intervention
Group B: Fractionated Er:Glass and Thulium LasersExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Assessments will be performed by blinded evaluators using standardized photographs at baseline.
2

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).

Time frame
Assessments will be performed by blinded evaluators using standardized photographs at 30 days after the last session.
3

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).

Time frame
Assessments will be performed by blinded evaluators using standardized photographs at 16 weeks after the last session.

Secondary outcomes

1

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.

Time frame
From baseline to 30 days after the end of the treatment
2

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.

Time frame
From baseline to 16 weeks after the end of the treatment
3

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.

Time frame
Baseline
4

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.

Time frame
30 days after the end of the treatment

Other outcomes

Sponsors and contacts

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