deviation (SD), standard error (SE) and/or range, as applicable, while qualitative data is presented as percentage (%). Two-sided Student's paired t-test was used to test for changes from baseline to follow up visits at 6 and 12 weeks after the last treatment. P values less than 0.05 were considered statistically significant.
RESULTS
Patient Demographics
Ten (10) subjects were enrolled and completed the study (Figure 1). The mean age at study consent was 62.7 (±8.4 (SD)) years (range, 49.8 to 77.9 years). Nine (9) subjects (90%) were female and 1 (10%) was male. All subjects were Caucasian. Eight (8) subjects had Fitzpatrick's skin type II (80%) and 2 had type III (20%; Table 1).
Primary outcome: Fitzpatrick Wrinkle and Elastosis Scale (FWES) and Global Aesthetic Improvement Scale (GAIS)
Three blinded evaluators evaluated the FWES score for the overall face as well as specific areas of the subjects’ upper lip, crow’s feet, and perioral area. The overall face FWES score improved from baseline from 5.97 (SE 0.20) to 5.78 (0.22) at 12- week follow-up, which was a mean change of -0.18 (0.10). The crow's feet FWES score improved from 5.75 (0.20) to 5.65 (0.22) which was a mean change of -0.10 (0.12). The upper lip FWES score improved from 4.96 (0.24) to 4.63 (0.27) which was a mean change of -0.30 (0.13) and was statistically significant (P=0.02). Finally, the perioral FWES score improved from 6.77 (0.27) to 6.33 (0.32), which was a mean change of -0.43 (0.12) and was statistically significant (P=0.002) (Table 2, Figure 2).
The same blinded evaluators evaluated the GAIS for changes in overall skin quality, pigment, and visible vascular regions. The score improved by 0.4 (SE 0.1) points at 12 weeks post treatment, which was a statistically significant improvement when compared to baseline (P=0.0004). Representative before and after photographs of a study subject are shown in Figure 3.
Secondary Outcomes: Subject Satisfaction
Subjects were on average more than satisfied with their treatment, with a mean score of 3.20 (0.25) at 12-weeks after the last treatment, which meant that on average subjects chose a score slightly higher than 'satisfied'. At the 6-week follow-up visit, 88.9% reported being at least 'satisfied' (55.6%) or 'very satisfied' (33.3%). By the 12-week follow-up visit, the percentage of subjects who were 'very satisfied' with the treatment, went up to 40%. No subjects reported dissatisfaction at either the 6- or 12-week follow-up.
Ninety percent (90%) of subjects reported either a mild (50%), moderate (20%) or significant (20%) improvement to their treatment areas at 12 weeks. The most common specific textural skin change was smoother skin (58% reported a noticeable change). The two most noticeable areas of improvement according to subjects at 12 weeks post last treatment were the periorbital (44.4%) and the peri-oral (44.4%). Eighty percent (80%) of subjects would recommend this treatment to a friend, per response at final follow-up of 12-weeks post last treatment.
Safety Outcomes: Pain, Tolerability, and Adverse Events
The treatments were well tolerated, with an average tolerability score of 3.1 (0.1) for all three treatments which corresponds to "tolerable" to "very tolerable". The average WBFS for all three treatments was 3.9 (0.4) out of 10, which corresponds to “mild” to “moderate” pain. There were no reports of adverse events or unanticipated side effects during the duration of the study.
Ten (10) subjects were enrolled and completed the study (Figure 1). The mean age at study consent was 62.7 (±8.4 (SD)) years (range, 49.8 to 77.9 years). Nine (9) subjects (90%) were female and 1 (10%) was male. All subjects were Caucasian. Eight (8) subjects had Fitzpatrick's skin type II (80%) and 2 had type III (20%; Table 1).
Primary outcome: Fitzpatrick Wrinkle and Elastosis Scale (FWES) and Global Aesthetic Improvement Scale (GAIS)
Three blinded evaluators evaluated the FWES score for the overall face as well as specific areas of the subjects’ upper lip, crow’s feet, and perioral area. The overall face FWES score improved from baseline from 5.97 (SE 0.20) to 5.78 (0.22) at 12- week follow-up, which was a mean change of -0.18 (0.10). The crow's feet FWES score improved from 5.75 (0.20) to 5.65 (0.22) which was a mean change of -0.10 (0.12). The upper lip FWES score improved from 4.96 (0.24) to 4.63 (0.27) which was a mean change of -0.30 (0.13) and was statistically significant (P=0.02). Finally, the perioral FWES score improved from 6.77 (0.27) to 6.33 (0.32), which was a mean change of -0.43 (0.12) and was statistically significant (P=0.002) (Table 2, Figure 2).
The same blinded evaluators evaluated the GAIS for changes in overall skin quality, pigment, and visible vascular regions. The score improved by 0.4 (SE 0.1) points at 12 weeks post treatment, which was a statistically significant improvement when compared to baseline (P=0.0004). Representative before and after photographs of a study subject are shown in Figure 3.
Secondary Outcomes: Subject Satisfaction
Subjects were on average more than satisfied with their treatment, with a mean score of 3.20 (0.25) at 12-weeks after the last treatment, which meant that on average subjects chose a score slightly higher than 'satisfied'. At the 6-week follow-up visit, 88.9% reported being at least 'satisfied' (55.6%) or 'very satisfied' (33.3%). By the 12-week follow-up visit, the percentage of subjects who were 'very satisfied' with the treatment, went up to 40%. No subjects reported dissatisfaction at either the 6- or 12-week follow-up.
Ninety percent (90%) of subjects reported either a mild (50%), moderate (20%) or significant (20%) improvement to their treatment areas at 12 weeks. The most common specific textural skin change was smoother skin (58% reported a noticeable change). The two most noticeable areas of improvement according to subjects at 12 weeks post last treatment were the periorbital (44.4%) and the peri-oral (44.4%). Eighty percent (80%) of subjects would recommend this treatment to a friend, per response at final follow-up of 12-weeks post last treatment.
Safety Outcomes: Pain, Tolerability, and Adverse Events
The treatments were well tolerated, with an average tolerability score of 3.1 (0.1) for all three treatments which corresponds to "tolerable" to "very tolerable". The average WBFS for all three treatments was 3.9 (0.4) out of 10, which corresponds to “mild” to “moderate” pain. There were no reports of adverse events or unanticipated side effects during the duration of the study.
