Treatment of Breast Lift/Reduction Scars

Study Overview
=================
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.

Official Title
-----------------
Treatment of Surgical Scars Following Breast Lifts/Reductions

Conditions
-----------------
Scars

Intervention / Treatment
-----------------
* Device: 2940nm and BBL treatment
* Other: Non-treatment side (Control)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy female subjects between 25 to 60 years of age inclusive Fitzpatrick skin type I-IV Subjects with post-surgical breast lift/reduction scar A maximum of 8-10 weeks since surgery Healed surgery wound in the treatment area Willing to have photographs taken of the treatment area Can read, understand and sign informed consent form (English only) Has indicated willingness to participate in the study by signing an informed consent form Agrees to adhere to the treatment and follow-up schedule and post treatment care instructions Exclusion Criteria: Fitzpatrick skin type V-VI Breast reconstruction with radiation treatment Is pregnant and/or lactating Has tattoos, dysplastic nevi in the treatment area History or current photosensitivity History or current use of medication with photosensitizing properties within past 6 months History or current of chronic reoccurring skin disease or disorder affecting treatment area History or current cancer of any type Has hormonal disorder Has signs of actinic bronzing Has open lacerations, and abrasions on the treatment area History of keloid formation, or hypertrophic scar formation, or poor wound healing History of bleeding disorder, or is currently taking anticoagulation medications Has significant concurrent illnesses (controlled or uncontrolled), such as diabetes, lupus, epilepsy, or cardiac disorders, which might be aggravated as a result of treatment Has participated in any clinical trial involving an investigational drug, device or cosmetic product or procedure within the past 30 days The investigator feels that for any reason the subject is not eligible to participate in the study.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Treatment arm and control arm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>2940nm laser and BBL treatment | Device: 2940nm and BBL treatment<br>* 2940nm and BBL treatment<br>|
| Experimental: Control Arm<br>One side of the treatment area will act as a control. No treatment on the control side. | Other: Non-treatment side (Control)<br>* No treatment<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in surgical scars | Degree of improvement in scars using photographs assessed via modified Vancouver scar scale | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall improvement | The Patient and Observer Scar Scale (POSAS) | 3 months | 
| Overall Improvement | Global Aesthetic Improvement Scale (GAIS) | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast reduction scars, Breast lift scars