Clinical outcome of 1064-nm fractional picosecond laser for the treatment of post-mastectomy scar in transmen: A randomized controlled trial study
Phase 4
Completed
- 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.
- Registration Number
- TCTR20230306002
- Lead Sponsor
- Division of Dermatology, Department of Medicine, Faculty of Medicine, Ramathibodi hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 22
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 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical scar improvement 0, 1, 2, 3, 4, 6, 9 months Modified Vancouver Scar Scale
- Secondary Outcome Measures
Name Time Method 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