Evaluation of the 755nm Alexandrite Laser for the Treatment of Scars

Study Overview
=================
Brief Summary
-----------------
Evaluate the safety and efficacy of removing unwanted scars using a 755nm Alexandrite laser.

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

Intervention / Treatment
-----------------
* Device: 755nm Alexandrite Laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Is a healthy male or female between 18 and 85 years old. Has unwanted scars (including atrophic, hypertrophic, hyper or hypo pigmented, erythematous )and wishes to undergo laser treatments to remove or improve them. Is willing to consent to participate in the study. Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits Exclusion Criteria: Is hypersensitive to light exposure. Has active localized or systemic infection. Is taking medication(s) for which sunlight is a contraindication. Has a history of squamous cell carcinoma or melanoma. Has a history of keloid scarring. Has used oral isotretinoin (Accutane®) within 12 months of initial treatment or plans on using during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment. Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications. Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period. Is allergic to lidocaine, tetracaine or Xylocaine with epinephrine. Has any other reason determined by the physician to be ineligible to participate in the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 755nm Alexandrite Laser<br>755nm Alexandrite Laser | Device: 755nm Alexandrite Laser<br>* 755nm Alexandrite Laser<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photographic Evaluation of Scar Clearance | The échelle d'évaluation clinique des cicatrices d'acné (ECCA) Grading scale was used to evaluate the photographs, using 2D and 3D photography, where the scale ranges from 0 to 4. 0 represents 0% improvement/worse, 1 is 1-25% improvement, 2 is 26-50% improvement, 3 is 51-74% improvement, and 4 is >75% improvement. | 1 Month Post Last Treatment | 
| Photographic Evaluation of Scar Clearance | The échelle d'évaluation clinique des cicatrices d'acné (ECCA) Grading scale was used to evaluate the photographs, using 2D and 3D photography, where the scale ranges from 0 to 4. 0 represents 0% improvement/worse, 1 is 1-25% improvement, 2 is 26-50% improvement, 3 is 51-74% improvement, and 4 is >75% improvement. | 3 Months Post Last Treatment |