Nonablative Fractional Diode Laser for Treatment of Skin Resurfacing and Pigmented Lesions

Study Overview
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Brief Summary
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This study is intended to evaluate the efficacy and safety of a new diode fractional laser for skin resurfacing and treatment of pigmented lesions.

Detailed Description
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This study is a prospective, open-label, clinical trial to study the effects of the nonablative, fractional diode laser for skin resurfacing. Up to 60 eligible participants will be enrolled at up to three (3) sites. Participants will receive up to 4 treatments to the face, and other off-face locations may be treated. Participants will complete follow-up visits for clinical evaluation and photography at 1 and 3 months after the final treatment.

Official Title
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Clinical Evaluation of a Nonablative Fractional 1940 nm Diode Laser for Skin Resurfacing and Treatment of Pigmented Lesions

Conditions
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Skin Texture, Pigmented Lesions

Intervention / Treatment
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* Device: Nonablative Fractional Diode Laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female Age 21 to 70 Fitzpatrick Skin Type I to V Willingness to have test spots and up to three (3) skin resurfacing treatments on the face Presence of pigmented lesions to be treated off the face must be rated at baseline as moderate or higher per Investigator or study staff Provide signed informed consent to participate in the study Adhere to study treatment and follow-up schedules Willing to have hair removed from the intended treatment area prior to treatment and/or photography Avoid sun exposure to all treated areas and use of sunscreen with sun protection factor (SPF) 30 or greater throughout the duration of the study Adhere to post-treatment care instructions Allow photography of treated areas and to release their use for scientific and/or promotional purposes Exclusion Criteria: Pregnant, planning to become pregnant, or breast feeding during the study Allergy to lidocaine or similar medications Excessively tanned skin in the intended treatment area Open wound or infection in the intended treatment area Tattoo(s) or permanent make-up in the intended treatment area Skin condition in the intended treatment area that could interfere with treatment or evaluation of safety or efficacy Presence or history of melasma Presence or history of skin cancer within the treatment area(s) History of keloid or hypertrophic scar formation History of herpes simplex virus (HSV) or similar condition in the intended treatment area unless treated with prophylactic medication Diagnosed coagulation disorder Immunosuppression Presence of any medical condition that in the opinion of the Investigator could impair healing or outcome as a result of treatment Use of systemic retinoid therapy (e.g. Accutane) during the past six (6) months Use of topical retinoid therapy in the intended treatment area during the past two (2) weeks Use of oral corticosteroid therapy during the past four (4) weeks Prior skin resurfacing treatment, such as surgery, light, laser or radiofrequency (RF) procedures in the intended treatment area during the past six (6) months Prior injectable dermal fillers in the intended treatment areas within the past twelve (12) months Prior injectable toxins (Botox) in the treated areas within the past three (3) months Subjects who in the opinion of the Investigator are unwilling or unable to adhere to the study requirements, or who are otherwise not a good candidate for the study

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 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: Nonablative Fractional Diode Laser<br>Single Group - single arm study. Group was treated with Nonablative Fractional Diode Laser | Device: Nonablative Fractional Diode Laser<br>* The FRAX 1940 is a fractional 1940 nm solid-state diode laser that delivers linear arrays of microbeams to create nonablative microscopic treatment zones (MTZs) in the skin.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pigmented Lesion Improvement by Blinded Evaluation | The primary efficacy endpoint was defined as improvement in the clearance of pigmented lesions, as assessed by three (3) blinded evaluators comparing photographs taken at Baseline/Pre-treatment and at the 1-month follow-up (post final treatment) | 1 month follow-up post treatment series, where treatment could last up to 10 weeks from baseline |