Clinical and Histological Evaluation of the 755nm Alexandrite Laser With Handpiece for the Treatment of Scars

Study Overview
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Brief Summary
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Compare efficacy and safety of handpieces on the 755nm Alexandrite laser for the treatment of scars.

Conditions
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Scars

Intervention / Treatment
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* Device: 755nm Alexandrite Laser with handpiece 2
* Device: 755nm Alexandrite Laser with handpiece 1
* Device: 755nm Alexandrite Laser with handpiece 3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is a healthy male or female between 18 and 85 years old Has unwanted scars not including atrophic scars and wishes to undergo laser treatments. Is willing to consent to participate in the study. Is willing to comply with all requirements of the study including biopsies, being photographed, following post treatment care and attending all treatment and follow up visits. Has Fitzpatrick skin types I to IV. Exclusion Criteria: The subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period. The subject is hypersensitive to light exposure OR takes photo sensitized medication. The subject has active or localized systemic infections. The subject has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy {greater than 81 mg per day}). The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study. The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 3 months prior to entering this study. The subject has used Accutane within 6 months prior to enrollment. The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial. The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate). The subject has a history of keloids. The subject has evidence of compromised wound healing. The subject has a history of squamous cell carcinoma or melanoma. The subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications. The subjects has an allergy to lidocaine and epinephrine.

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 755nm Alexandrite Laser with Handpiece 2<br>Focusing energy on skin | Device: 755nm Alexandrite Laser with handpiece 2<br>* Focusing energy on skin<br>|
| Experimental: 755nm Alexandrite Laser with handpiece 3<br>Focusing energy on skin | Device: 755nm Alexandrite Laser with handpiece 3<br>* Focusing energy on skin<br>|
| Experimental: 755nm Alexandrite laser with handpiece 1<br>Focusing energy on skin | Device: 755nm Alexandrite Laser with handpiece 1<br>* focusing energy at skin surface<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Biopsy Sampling | Histological examination of tissue samples will be compared between baseline and 3 months post treatment. | 3 months post last treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photographic evaluation as a measure of improvement. | 2D photographs to be taken at each visit and assessed at the end of the study by 2-3 blinded assessors for improvement. | up to 3 months post last treatment | 
| Subject Biopsy Sampling | Histological examination of tissue samples will be compared between baseline and 2 weeks post treatment. | 2 weeks post treatment | 
| Subject Biopsy Sampling | Histological examination of tissue samples will be compared between baseline and 1 month post treatment. | 1 month post treatment |