Scars
Conditions
Keywords
Breast reduction scars, Breast lift scars
Brief summary
Laser and light treatment for surgical scars following breast lifts/reductions
Detailed description
The purpose of the study is to demonstrate effectiveness of laser and light therapy for the treatment of surgical scars following breast lifts/reductions.
Interventions
DEVICE2940nm and BBL treatment
2940nm and BBL treatment
OTHERNon-treatment side (Control)
No treatment
Sponsors
Sciton
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Treatment arm and control arm
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy female subjects between 25 to 60 years of age inclusive 2. Fitzpatrick skin type I-IV 3. Subjects with post-surgical breast lift/reduction scar 4. A maximum of 8-10 weeks since surgery 5. Healed surgery wound in the treatment area 6. Willing to have photographs taken of the treatment area 7. Can read, understand and sign informed consent form (English only) 8. Has indicated willingness to participate in the study by signing an informed consent form 9. Agrees to adhere to the treatment and follow-up schedule and post treatment care instructions
Exclusion criteria
1. Fitzpatrick skin type V-VI 2. Breast reconstruction with radiation treatment 3. Is pregnant and/or lactating 4. Has tattoos, dysplastic nevi in the treatment area 5. History or current photosensitivity 6. History or current use of medication with photosensitizing properties within past 6 months 7. History or current of chronic reoccurring skin disease or disorder affecting treatment area 8. History or current cancer of any type 9. Has hormonal disorder 10. Has signs of actinic bronzing 11. Has open lacerations, and abrasions on the treatment area 12. History of keloid formation, or hypertrophic scar formation, or poor wound healing 13. History of bleeding disorder, or is currently taking anticoagulation medications 14. Has significant concurrent illnesses (controlled or uncontrolled), such as diabetes, lupus, epilepsy, or cardiac disorders, which might be aggravated as a result of treatment 15. Has participated in any clinical trial involving an investigational drug, device or cosmetic product or procedure within the past 30 days 16. The investigator feels that for any reason the subject is not eligible to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in surgical scars | 3 months | Degree of improvement in scars using photographs assessed via modified Vancouver scar scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall improvement | 3 months | The Patient and Observer Scar Scale (POSAS) |
| Overall Improvement | 3 months | Global Aesthetic Improvement Scale (GAIS) |
Countries
United States
Outcome results
None listed