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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Miami Dermatology and Laser Institute
Miami, Florida, United States
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)
Time frame: 1 month follow-up post treatment series, where treatment could last up to 10 weeks after baseline
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).
Time frame: 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.
Time frame: 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
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Time frame: 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
Time frame: 1 month follow-up post treatment series, where treatment could last up to 10 weeks after baseline