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Clinical outcome of 1064-nm fractional picosecond laser for the treatment of post-mastectomy scar in transmen: A randomized controlled trial study

Clinical outcome of 1064-nm fractional picosecond laser for the treatment of post-mastectomy scar in transmen: A randomized controlled trial study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230306002
Enrollment
30
Registered
2023-03-06
Start date
2021-03-26
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Efficacy and safety of 1064-nm fractional picosecond laser (FxPico) treatment for hypertrophic and atrophic post-mastectomy scars in transmen. Atrophic scar, Female-to-male transgender, Hypertrophic scar, Picosecond laser, Post-mastectomy scar, Transgender men, and Transmen.

Interventions

Fractional picosecond 1064-nm laser (EnlightenTM System
Cutera Inc., Brisbane, CA) with microlens array (MLA) for 4 sessions at 4-week intervals using the following parameters: spot size 10 mm, fluence 0.80 to 1.0 J/cm2, frequency 5 to Hz, and 3 to 4 passe
Fractional picosecond laser,No treatment

Sponsors

Division of Dermatology, Department of Medicine, Faculty of Medicine, Ramathibodi hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Transmen wth symmetrical hypertrophic or atrophic mastectomy scars evaluated by a board-certified dermatologist were participated in the study.

Exclusion criteria

Exclusion criteria: Exclusion criteria included 1) severe comorbidities, 2) co-occurring skin infection or inflammation or open wound or acne at the scar site, 3) history of immunodeficiency, skin cancer, coagulopathy, or recurrent herpes infection, 4) pregnancy or breastfeeding, and 5) history of scar treatment within 3 months prior to the study.

Design outcomes

Primary

MeasureTime frame
Clinical scar improvement 0, 1, 2, 3, 4, 6, 9 months Modified Vancouver Scar Scale

Secondary

MeasureTime frame
Scar texture/roughness 0, 1, 2, 3, 4, 6, 9 months Antera 3D,Scar melanin level 0, 1, 2, 3, 4, 6, 9 months Antera 3D,Scar hemoglobin level 0, 1, 2, 3, 4, 6, 9 months Antera 3D,Participant satisfaction 9 months VAS,Histopathological changes 0, 9 months H&E, Alcian blue, VVG

Countries

Thailand

Contacts

Public ContactSuthinee Rutnin

Faculty of Medicine, Ramathibodi hospital

suthinee.rutnin@gmail.com0926245635

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026