across 6 treatments was 3.4 ± 2.0, and 57% to 74% of women (depending on number of treatments) requested topical anesthesia. Side effects observed immediately posttreatment by most patients over the 6 treatments included mild edema and mild to moderate erythema and heat sensation. While severe edema was not observed, a few patients experienced severe erythema and heat sensation posttreatment. Desquamation (eg, flaking) was observed at 1 (n=1) and 3 months (n=2) posttreatment. PIH was observed on one Asian woman with Fitzpatrick skin type IV and resolved within 2 months posttreatment.
A retrospective analysis assessed 11 patients (Fitzpatrick skin type II [n=4], III [n=3], IV [n=4]) with melasma who had ≥1 treatment during a 2-year period with a 595 nm pulsed dye laser in combination with the 1927 nm wavelength handpiece of the NFDL system.17 Patients were treated at 4 to 6 week intervals with the 595 nm pulsed dye laser (10 mm spot size; 10– 20 ms pulse duration; 7.5–8.5 J/cm2 fluence; dynamic cooling device spray duration 30 ms and delay 30 ms) followed, after ~10-15 minutes for skin cooling, by treatment over the entire face with the 1927 nm wavelength handpiece of the NFDL system (8 passes; 5 mJ/pulse; depth, 170 μm; coverage, 5%). An independent clinician assessed photographs and measured improvement in melasma and erythema using a 4-point scale (1 = 0 to <25%; 2 = 25% to <50%; 3 = 50% to <75%; 4 = 75% to 100%); patient-rated treatment satisfaction was assessed using a 3-point scale (0 = not satisfied; 2 = very satisfied). The mean number of combined treatments was 4 (range, 2–11), and the mean length of follow-up posttreatment was 96 days (range, 21–249 days). A >50% improvement from baseline in melasma and erythema was observed in 54.5% (6/11) and 63.6% (7/11) of patients, respectively. The 10 patients who had satisfaction data reported being “satisfied†or “very satisfied†with treatment (overall mean score, 1.6). No rebound melasma, PIH, postinflammatory hypopigmentation, or other AEs were observed. Of note, interim results from a separate clinical trial found improvements at 6 months posttreatment in 25 patients with melasma treated with the 1927 nm wavelength handpiece of the NFDL system in combination with topical tranexamic acid (personal communication, Roy G. Geronemus).
A randomized study was conducted with 40 patients with Fitzpatrick skin type III–V and moderate to severe facial hyperpigmentation (≥4 hyperpigmentation scale) related to photodamage or melasma.18 Patients received 4 treatments at 2-week intervals with the 1927 nm wavelength handpiece of the NFDL system and were randomly assigned to apply topical hydroquinone 2% cream or bland moisturizer immediately after laser treatment with the 1927 nm wavelength handpiece (8 passes; spot size, 140 μm; 5 mJ/pulse; depth, 170 μm; coverage, 5%). Clinicians blinded to treatment evaluated digital images using the Mottled Pigmentation Area and Severity Index (MoPASI),24 a 10-point scale (0 = none; 9 = severe) for hyperpigmentation and photodamage and the 5-point (1 = very much improved; 5 = worse) Global Aesthetic Improvement Scale (GAIS).25 Additionally, patients rated satisfaction with their appearance using a 6-point scale (1 = extremely satisfied; 6 = extremely dissatisfied).
Results from this study showed significant improvements from baseline for both treatment groups at week 4 posttreatment in blinded clinician-assessed MoPASI scores (P≤0.001 for both groups), hyperpigmentation (P≤0.001 for both groups), and photodamage (hydroquinone, P=0.01; moisturizer, P=0.02).18 Significant improvements from baseline were maintained through week 12 (P≤0.001 for both groups) for all 3 assessments. Compared with baseline, patients from both treatment groups were significantly more satisfied with their facial appearance at week 4 (hydroquinone, P=0.003; moisturizer, P≤0.001) and week 12 (P≤0.001 for both groups). When comparing the treatment groups, there was a significant difference in improvement from baseline in GAIS score favoring the laser + hydroquinone group at week 12 (P=0.02). Though patients in the laser + moisturizer group were significantly more satisfied with their appearance compared with those in the laser + hydroquinone group (P=0.02), overall 88.2% (30/34) of patients included in the study felt satisfied with their appearance at week 12.
A retrospective study was conducted with 61 patients with Fitzpatrick skin type IV (n=45), V (n=10), and VI (n=6) who had PIH. Patients received monthly treatments with the 1927 nm wavelength handpiece of the NFDL system (fixed spot size, 140 μm; 5 mJ/pulse; depth, 170 μm; coverage, 5%).19 Determination of the number of treatments required for improvement of PIH and evaluation of response based on Fitzpatrick skin type were among the objectives of the study. Patients received 2 (n=15), 3 (n=14), 4 (n=16), or ≥5 (n=16) treatments. Two independent clinicians, who had a statistically significant correlation between their grading during the study, assessed improvement in pigmentary clearance from photographs taken prior to each treatment using a 0 to 100% numeric scale. Overall, the mean percentage (± SD) improvement in pigmentary clearance was 43.2% ± 25.4%. No significant differences in mean improvement from baseline were observed among patients receiving different numbers of treatments or across Fitzpatrick skin types, although authors noted a trend favoring darker skin types and suggested the study may have been underpowered to fully assess this parameter. There were no reported side effects or worsening of PIH with treatment. The 1927 nm wavelength handpiece of the NFDL system was safe and demonstrated at least moderate improvement for the treatment of PIH in darker skin types.
A retrospective analysis assessed 11 patients (Fitzpatrick skin type II [n=4], III [n=3], IV [n=4]) with melasma who had ≥1 treatment during a 2-year period with a 595 nm pulsed dye laser in combination with the 1927 nm wavelength handpiece of the NFDL system.17 Patients were treated at 4 to 6 week intervals with the 595 nm pulsed dye laser (10 mm spot size; 10– 20 ms pulse duration; 7.5–8.5 J/cm2 fluence; dynamic cooling device spray duration 30 ms and delay 30 ms) followed, after ~10-15 minutes for skin cooling, by treatment over the entire face with the 1927 nm wavelength handpiece of the NFDL system (8 passes; 5 mJ/pulse; depth, 170 μm; coverage, 5%). An independent clinician assessed photographs and measured improvement in melasma and erythema using a 4-point scale (1 = 0 to <25%; 2 = 25% to <50%; 3 = 50% to <75%; 4 = 75% to 100%); patient-rated treatment satisfaction was assessed using a 3-point scale (0 = not satisfied; 2 = very satisfied). The mean number of combined treatments was 4 (range, 2–11), and the mean length of follow-up posttreatment was 96 days (range, 21–249 days). A >50% improvement from baseline in melasma and erythema was observed in 54.5% (6/11) and 63.6% (7/11) of patients, respectively. The 10 patients who had satisfaction data reported being “satisfied†or “very satisfied†with treatment (overall mean score, 1.6). No rebound melasma, PIH, postinflammatory hypopigmentation, or other AEs were observed. Of note, interim results from a separate clinical trial found improvements at 6 months posttreatment in 25 patients with melasma treated with the 1927 nm wavelength handpiece of the NFDL system in combination with topical tranexamic acid (personal communication, Roy G. Geronemus).
A randomized study was conducted with 40 patients with Fitzpatrick skin type III–V and moderate to severe facial hyperpigmentation (≥4 hyperpigmentation scale) related to photodamage or melasma.18 Patients received 4 treatments at 2-week intervals with the 1927 nm wavelength handpiece of the NFDL system and were randomly assigned to apply topical hydroquinone 2% cream or bland moisturizer immediately after laser treatment with the 1927 nm wavelength handpiece (8 passes; spot size, 140 μm; 5 mJ/pulse; depth, 170 μm; coverage, 5%). Clinicians blinded to treatment evaluated digital images using the Mottled Pigmentation Area and Severity Index (MoPASI),24 a 10-point scale (0 = none; 9 = severe) for hyperpigmentation and photodamage and the 5-point (1 = very much improved; 5 = worse) Global Aesthetic Improvement Scale (GAIS).25 Additionally, patients rated satisfaction with their appearance using a 6-point scale (1 = extremely satisfied; 6 = extremely dissatisfied).
Results from this study showed significant improvements from baseline for both treatment groups at week 4 posttreatment in blinded clinician-assessed MoPASI scores (P≤0.001 for both groups), hyperpigmentation (P≤0.001 for both groups), and photodamage (hydroquinone, P=0.01; moisturizer, P=0.02).18 Significant improvements from baseline were maintained through week 12 (P≤0.001 for both groups) for all 3 assessments. Compared with baseline, patients from both treatment groups were significantly more satisfied with their facial appearance at week 4 (hydroquinone, P=0.003; moisturizer, P≤0.001) and week 12 (P≤0.001 for both groups). When comparing the treatment groups, there was a significant difference in improvement from baseline in GAIS score favoring the laser + hydroquinone group at week 12 (P=0.02). Though patients in the laser + moisturizer group were significantly more satisfied with their appearance compared with those in the laser + hydroquinone group (P=0.02), overall 88.2% (30/34) of patients included in the study felt satisfied with their appearance at week 12.
A retrospective study was conducted with 61 patients with Fitzpatrick skin type IV (n=45), V (n=10), and VI (n=6) who had PIH. Patients received monthly treatments with the 1927 nm wavelength handpiece of the NFDL system (fixed spot size, 140 μm; 5 mJ/pulse; depth, 170 μm; coverage, 5%).19 Determination of the number of treatments required for improvement of PIH and evaluation of response based on Fitzpatrick skin type were among the objectives of the study. Patients received 2 (n=15), 3 (n=14), 4 (n=16), or ≥5 (n=16) treatments. Two independent clinicians, who had a statistically significant correlation between their grading during the study, assessed improvement in pigmentary clearance from photographs taken prior to each treatment using a 0 to 100% numeric scale. Overall, the mean percentage (± SD) improvement in pigmentary clearance was 43.2% ± 25.4%. No significant differences in mean improvement from baseline were observed among patients receiving different numbers of treatments or across Fitzpatrick skin types, although authors noted a trend favoring darker skin types and suggested the study may have been underpowered to fully assess this parameter. There were no reported side effects or worsening of PIH with treatment. The 1927 nm wavelength handpiece of the NFDL system was safe and demonstrated at least moderate improvement for the treatment of PIH in darker skin types.
