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

NCT ID: NCT07151599

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-16
• Study Completion Date: 2026-07-31

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.

Conditions

Acne Scars

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Microneedling

Microneedling performed with an electronic pen and sterile disposable cartridge of 12 needles at 2mm depth

Group Type: ACTIVE_COMPARATOR

Microneedling

Intervention Type: 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 and Thulium Lasers

Fractional Erbium:Glass laser is applied first, focused on scarred areas, followed immediately by fractional Thulium 1927 nm over the full face.

Group Type: EXPERIMENTAL

Fractionated Er:Glass Laser combined to Fractionated Thulium Laser

Intervention Type: 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.

Interventions

Microneedling

Microneedling performed with an electronic pen and sterile disposable cartridge with 12 needles and 2mm depth, three treatment sessions at four-week intervals.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Christiane Pavani

Randomized Controlled Trial Comparing Combined Fractional Erbium:Glass and Thulium Lasers Versus Microneedling for the Treatment of Atrophic Acne Scars

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christiane Pavani, PhD

Role: STUDY_CHAIR

University of Nove de Julho

Luciana Khachikian, Master Student

Role: PRINCIPAL_INVESTIGATOR

University of Nove de Julho

Locations

Espaço Conceito Medical San

São Paulo, , Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Luciana Khachikian, Master student

Role: CONTACT

lucianacamargo@uni9.edu.br

+5511989969924

Facility Contacts

Luciana C Khachikian

Role: primary

mestrado.lucianakha@gmail.com

+5511983313093

Other Identifiers

ErGlass_MedicinaBiofotonica

Identifier Type: -

Identifier Source: org_study_id