Methods

A total of 78 patients enrolled into a post-market surveillance evaluation investigating the efficacy of the Perméa laser in conjunction with the SkinCeuticals topical skincare regimen. Informed consent was obtained. All patients were between the ages of 20 and 75 years, with mild to moderate photodamage and/or dyspigmentation. Fitzpatrick skin types I–V were included in this study. All patients agreed to start and continue the skincare regimen (gentle cleanser, CE Ferulic acid serum, and sunscreen SPF 50) on the treatment area during the course of the study, while discontinuing or minimising the use of other topical cosmeceutical agents. Patients were instructed to cleanse the skin 1–2 times per day with the gentle cleanser and apply two or three drops of serum to the face at night. During the daytime, patients were instructed to apply the SPF 50 sunscreen to the full face and reapply as needed. Patients consented to have photographs taken prior to the first treatment, at the fourth treatment visit, and at the 2-week follow-up after the sixth, and final, laser treatment. After the fourth treatment, patients completed a satisfaction survey, and 2 weeks after the sixth treatment patients completed a final questionnaire assessing their overall satisfaction with the treatments and skincare products.

Patients

Seventy-eight patients (75 females and 3 males), aged 23–75 years (mean age 46.5 ± 11.2 years) were evaluated. Four patients (5%) were Fitzpatrick skin type I; 30 patients (39%) were skin type II; 29 patients (37%) were skin type III; 14 patients (18%) were skin type IV; and one patient (1%) was skin type V. At baseline, 39 patients (50%) had previously tried microdermabrasion, chemical peels, and photofacial (intense pulsed light; IPL) (Figure 1). Eighteen patients (23%) had previously had a more aggressive laser treatment, such as non-ablative thulium or erbium laser, fractional CO2 laser, or ablative CO2 laser treatment. Seven patients (9%) in the study had previously undergone a 1440 nm Clear + Brilliant laser treatment. Patient-reported goals for treatment outcome were (Figure 2):

Table 1

  • 38 (49%) wanted clearer skin
  • 48 (62%) wanted more youthful skin
  • 55 (71%) wanted less discolouration/more even skin tone
  • 35 (45%) wanted smoother skin.

Treatments

The device used in this study was a 1927 nm fractionated diode laser (Clear + Brilliant Perméa, Solta Medical, Hayward, CA). The area was cleansed prior to treatment with a mild cleanser. No topical anaesthetic was applied to the patients’ skin. Based on patient tolerance, treatments were performed using settings of low (2.5% coverage), medium (3.75% coverage) or high (5% coverage) at a fixed energy level of 5 mJ. Four passes were performed over each anatomical unit of the face (i.e. left cheek, forehead, right cheek, chin). After the four passes were completed, 1–2 drops of CE Ferulic serum were applied and spread evenly over the surface of the treated anatomical unit. The next anatomical treatment area of the face was treated until the entire face was treated (with a total of 4–6 drops of serum spread over the entire face). Once the serum was absorbed into the skin, a patented Bio-Cellulose mask was applied to the full face for 10–15 minutes. After the mask was removed, patients were supplied with home-use samples (serum, SPF, and cleanser) to use for the duration of the full treatment series.

Figure 3

Patients underwent six treatment sessions at 2-week intervals. Following each laser treatment, patients were monitored for side-effects and adverse events. Patients were asked to score pain immediately following treatment based on a visual analogue scale (VAS) of 0 (no pain) to 10 (worst pain). Patients were advised to avoid sun exposure for 7–10 days after the laser treatment and to use the home-use samples of daily broad-spectrum sunscreen on the treated areas.

Results

A total of 68 (87%) subjects completed the fourth treatment visit, and 66 (85%) subjects completed all treatments and the final follow-up 2 weeks after the sixth (final) treatment session. One subject was removed from the study owing to hyperpigmentation observed following the third treatment, with no other adverse events reported.

Figure 4 (A) This 55-year-old patient had moderate photoageing and dyschromia on the forehead and lateral cheek areas. (B) After four laser treatments in combination with the skincare regimen, improvement is seen at the forehead and bilateral cheek areas

Figure 4 (A) This 55-year-old patient had moderate photoageing and dyschromia on the forehead and lateral cheek areas. (B) After four laser treatments in combination with the skincare regimen, improvement is seen at the forehead and bilateral cheek areas

On average across all treatments, subjects were treated at a mean treatment level of 2.8 ± 0.5, correlating to the higher treatment level (level 3). The mean pain score immediately following treatment (average across all six treatment visits) was 3.6 ± 1.7. Patients were treated at a low (level 1) setting 4% of the time, at a moderate (level 2) setting 15% of the time, and at a high (level 3) setting 81% of the time (Figure 3).

A high percentage of patients (78%) reported noticeable improvement in skin tone or texture 2 weeks after the first treatment, with similar improvement ratings following treatments two through six (Table 1).

Figure 5 (A) This 31-year-old Hispanic patient had mild lentigines of the upper and lateral cheek area. (B)  Improvement is noted after four laser treatments

Figure 5 (A) This 31-year-old Hispanic patient had mild lentigines of the upper and lateral cheek area. (B) Improvement is noted after four laser treatments

At the fourth treatment visit, subjects were asked to rate their satisfaction with the results of the treatment series to date, using a scale of 1 = very satisfied, 2 = satisfied, 3 = neutral, 4 = dissatisfied, and 5 = very dissatisfied. Mean satisfaction score at the fourth treatment visit was satisfied to very satisfied, with a mean value of 1.8 ± 0.7. Eighty-two percent of subjects reported being satisfied to very satisfied with treatment at this time (Table 2). No subjects reported being dissatisfied or very dissatisfied with the results of the treatment at the fourth treatment visit. Subjects were also asked to rate their overall experience with the treatments at the fourth treatment visit, using the 1–5 satisfaction scale described above. Mean satisfaction with overall experience at the fourth treatment visit was also high, with a mean value of 1.8 ± 0.8.