Efficacy and Safety of Fractional 1064 nm Picosecond Laser for the Treatment of Mammoplasty Scar in Asians: A Prospective, Randomized Comparative Study
Phase 4
Recruiting
- Conditions
- Patients with mammoplasty scar s on both sided of breastmammoplasty scar, picosecond laser, fractional 1064 nm picosecond laser
- Registration Number
- TCTR20210730001
- Lead Sponsor
- Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 24
Inclusion Criteria
1. Female aged 18-60 years
2. Had hypertrophic scars on both breasts after breast surgery
and did not receive any hypertrophic scar treatments in the past 6 months prior to enrolment or did bilateral breast surgery within 1 month prior to enrollment.
3. Conducted breast surgery due to breast cancer, breast augmentation, or breast reduction
Exclusion Criteria
1. Patients having infection or active wound in the test area
2. Patients with herpes infection or having a history of herpes infection
3. Immunocompromised patients
4. Patients with connective tissue disease
5. Receiving immunosuppressive drugs
6. Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Skin texture (Roughness) Baseline, 1 , 3, and 6 months after treatment Antera analysis
- Secondary Outcome Measures
Name Time Method Scar volume Baseline, 1 , 3, and 6 months after treatment Antera analysis,Skin pigmentation Baseline, 1 , 3, and 6 months after treatment Antera analysis,Physician improvement scale Baseline, 1 , 3, and 6 months after treatment 6 points scale,Patient and Observer Scar Assessment Scale Baseline, 1 , 3, and 6 months after treatment POSAS score,Safety Baseline, 1 , 3, and 6 months after treatment Adverse event