Nonablative Fractional Diode Laser for Treatment of Pigmented Lesions

Study Overview
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Brief Summary
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This study is being conducted to evaluate the safety and efficacy of a fractional diode laser for treatment of pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sunspots), and ephelides (freckles).

Detailed Description
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Prospective, open-label, clinical trial to study the effects of the nonablative, fractional diode laser for treatment of pigmented lesions. Up to 60 eligible participants will be enrolled at up to five (5) sites. Participants will receive up to three (3) treatments in the following treatment areas: face, hands, arms, back, chest, or legs. Participants will complete follow-up visits for clinical evaluation and photography at 1 and 3 months after the final study treatment.

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

Conditions
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Pigmented Skin Lesion

Intervention / Treatment
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* Device: FRAX 1940 nm 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 VI Willingness to have test spots and up to three (3) treatments for pigmented lesions on or off the face which are 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 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 disorder 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 treatment, such as surgery, light, laser or radiofrequency (RF) procedures in the intended treatment area during the past three (3) months Prior injectable dermal fillers (e.g. collagen, hyaluronic acid) in the intended treatment area within the past 12 months Prior injectable toxins (e.g. Botox) in the intended treatment area 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: Single Group<br>Single Arm: All subjects will undergo treatment of pigmented lesions with a 1940 nm diode laser | Device: FRAX 1940 nm laser<br>* A fractional 1940 nm solid-state diode laser will deliver linear arrays of microbeams to create nonablative microscopic treatment zones (MTZs) in the skin, in order to treat pigmented skin lesions.<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 after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pigmentation Improvement at the 3-month Follow-up, by Blinded Evaluation | The secondary endpoint was pigmentation improvement at the 3-month follow-up, as assessed by three (3) blinded evaluators comparing photographs taken at Baseline/Pre-treatment and at the 3-month follow-up (post final treatment). The treated area was considered a success if at least two of the three reviewers correctly identified the post-treatment photograph (i.e. left or right side). | 3-months post final treatment, where treatment series could last up to 10 weeks after baseline | 
| Blinded Assessment of Textural Improvement Using a 5-point Global Aesthetic Improvement Scale (GAIS) | For each reviewer assessment: If the post-treatment photograph was identified correctly, the reviewer's assessment on the textural scale was coded as follows: -1=worse, 0=no change; 1=improved; 2=much improved; and 3=very much improved. If not identified correctly, the scale was reversed (-1=improved, 0=no change, 1=worsened, 2=much worsened and 3=very much worsened). Results were based on the majority rule of the assessments by the three blinded reviewers; in other words, the mode of the three blinded reviewers' scores was used as the treated area clearance results, while the median was used if three different scores were reported. | 1 month follow-up post treatment series, where treatment could last up to 10 weeks after baseline | 
| Subject Assessment of Improvement Using a 5-point Global, Aesthetic Improvement Scale (GAIS) | Subject assessments of treatment outcome were completed at the 1-month follow-up using the Global Assessment Improvement Scale (GAIS). The scale was coded as follows: -1=worse, 0=no change; 1=improved; 2=much improved; and 3=very much improved | 1 month follow-up post treatment series, where treatment could last up to 10 weeks after baseline | 
| Subject Satisfaction With Treatment Results | Subject satisfaction with treatment results completed at the 1-month follow-up using a 5 point scale coded as follows: -1=not satisfied, 0=little satisfied; 1=somewhat satisfied; 2=satisfied; and 3=very satisfied | 1 month follow-up post treatment series, where treatment could last up to 10 weeks after baseline |