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

U

University of Nove de Julho

Status

Enrolling

Conditions

Acne Scars

Treatments

Device: Fractionated Er:Glass Laser combined to Fractionated Thulium Laser
Device: Microneedling

Study type

Interventional

Funder types

Other

Identifiers

NCT07151599
ErGlass_MedicinaBiofotonica

Details and patient eligibility

About

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.

Full 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.

Enrollment

84 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

84 participants in 2 patient groups

Microneedling
Active Comparator group
Description:
Microneedling performed with an electronic pen and sterile disposable cartridge of 12 needles at 2mm depth
Treatment:
Device: Microneedling
Fractionated Er:Glass and Thulium Lasers
Experimental group
Description:
Fractional Erbium:Glass laser is applied first, focused on scarred areas, followed immediately by fractional Thulium 1927 nm over the full face.
Treatment:
Device: Fractionated Er:Glass Laser combined to Fractionated Thulium Laser

Trial contacts and locations

1

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Central trial contact

Luciana Khachikian, Master student

Data sourced from clinicaltrials.gov

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