755nm Alex Laser for Treatment of Pigmented and Vascular Lesions and Scars

Study Overview
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Brief Summary
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Evaluation of the safety and efficacy of the 755nm Alex laser for the treatment of benign pigmented and vascular lesions and scars

Conditions
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Benign Pigmented and Vascular Lesions and Scars

Intervention / Treatment
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* Device: 755nm Alex laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male or female subjects between 18 and 85 years of age. Subjects with Fitzpatrick skin types I to VI. Subjects who have unwanted pigmented lesions, vascular lesions, striae and/or hypertrophic or atrophic scars Subject who are willing to consent to participate in the study. 4.2 Exclusion Criteria Subject who will not be photographed or who will not cooperate with the post treatment care and follow up schedule Hypersensitive to light exposure. Active localized or systemic infections. Taking medication for which sunlight is a contraindication. History of squamous cell carcinoma or melanoma. History of keloid scarring. Use of oral isotretinoin (Accutane®) within 12 months of initial treatment or during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment. Prior treatment with laser or other devices in treatment area within 3 months History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications. Subjects who are pregnant, have been pregnant within the last 3 months, are currently breast feeding or are planning a pregnancy within the study period. Subjects that the physician determines ineligible based on standard of care treatment. - -

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clearance Based on Photographic Scale | This scale ranges from 0 to 3, where 0 is 0-25% clearance, 1 is 26-50% clearance, 2 is 51-75% clearance and 3 is 76-100% clearance. The baseline picture was compared to a photograph taken at the follow up visit. The number of patients that fell into each category was recorded. | 1 months post last treatment | 
| Clearance Based on Photographic Scale | This scale ranges from 0 to 3, where 0 is 0-25% clearance, 1 is 26-50% clearance, 2 is 51-75% clearance and 3 is 76-100% clearance. The baseline picture was compared to a photograph taken at the follow up visit. The number of patients that fell into each category was recorded. | 3 months post last treatment |