Yes!
A clinical study with 34 patients was conducted to support the safety and effectiveness of the SkinStylus SteriLock® MicroSystem for the treatment of scars on the abdomen.
The study was conducted at a single center and included treatments on day 1, day 15, and day 31, with follow-up visits at 90 days from day 31 and 6 months after the final (day 31) treatment. Treatments were conducted by licensed and trained aestheticians (skin care specialists) who were supervised by a licensed dermatologist. The scar was photographed and then was divided into a treatment half and a control half. Both sides were cleaned and numbed prior to treatment. A thin layer of lubricant was applied to both sides prior to treatment to protect against abrasion and friction during the procedure.
The aestheticians were instructed to start at a depth setting of 1.0 mm and increase the depth to 2.5mm on all patients until localized petechia and mild, localized capillary bleeding was observed on the treatment side of the scar structure. All three cartridge types were used on every patient and all patients received some portion of each treatment at a depth of 2.5mm. Following treatment, the area was cleaned with sterile saline and a sterile gauze dressing was applied.
A total of 34 subjects completed the study. 30 of those subjects had a scar located on the abdomen. Subjects enrolled in the study included men (5.8%) and women (94.2%) over age 22. The study included 12/34 subjects with Fitzpatrick Skin Type (FST) IV – VI.
Table 1: Summary of Demographic Information
| Total # of subjects applies | 38 | | Sex | # | % |
| Total # of subjects approved after screening | 36 | | Male | 2 | 5.88% |
| Total # of subjects completing trial | 34 | | Female | 34 | 94.20% |
| Total # of subjects completing trial with scar on abdomen | 30 | | Ethnicity | | |
| Mean Age (years) | 47.50 | | Hispanic or Latino | 9 | 26.47% |
| Mean (standard deviation) | 1.52 | | Non-Hispanic or Latino | 27 | 79.41% |
| Minimum | 26 | | Race | | |
| Maximum | 60 | | American Indian or Alaskan Native | 1 | 2.94% |
| | | | Asian | 2 | 5.88% |
| | | | Black or African American | 2 | 5.88% |
| | | | White | 31 | 91.18% |
| | | | Fitzpatrick Skin Type | | |
| | | | I | 1 | 2.94% |
| | | | II | 13 | 38.24% |
| | | | III | 12 | 35.29% |
| | | | IV | 7 | 20.59% |
| | | | V | 3 | 8.82% |
| | | | VI | 2 | 5.88% |
At each clinical visit, digital images were taken of each subject’s scars, before and after treatment. After the first treatment, on each subsequent treatment, objective and subjective data were obtained from patients regarding the occurrence of any adverse event or other sequel. On day 1, day 15, and day 31 imaging was performed before and after treatment. 90 days after the last treatment (day 31), grading images were obtained. These images were graded by the following blinded graders: a Board Certified Dermatologist and two Board Certified Plastic Surgeons after completion of the study using the following assessment tools [Table 2]. Details of each of these assessment tools are provided below in Tables 3 and 4. The results of the study are provided in Tables 5 and 6.
Table 2: Study Endpoints
| Primary Effectiveness Endpoint | Previous research has established the Minimal Clinical Important Difference (MCID) for the validated Visual Analogue Scale (VAS) to be an improvement of at least 10 mm on a 100 mm scale from baseline treatment side photos to photos taken of treatment side 90 days after last of 3 treatments. The treatment site photos were also correlated to the graded non-treatment side control photos. |
| Secondary Effectiveness Endpoint | Self-assessed Scar Improvement Scale completed by subjects at 90 days after last of 3 treatments on the same side. |
| Subject Global Aesthetic Improvement Scale completed by subjects at 90 days after last of 3 treatments on the same side. |
| Safety Endpoint | Adverse event monitoring at each visit; treatment 2, treatment 3, 90 days after treatment 3, and 6 months after treatment 3. |
The photo grading included the following effectiveness assessments using a 100 mm VAS scale:
Each subject had a scar on the abdomen that had been photographed and divided into a treatment segment and an untreated/control segment, roughly equal in length to each other. The same half of the scar was treated with microneedling on three separate treatment appointments at least 14 days apart. At each of the three treatment appointments, a different cartridge array type was used, but the order was randomized and each subject had to receive one treatment from each of the three cartridges.
At 90 days after the last treatment, both sides of the scar (treated side and untreated/control side) were photographed. The photographs were not retouched and were arranged in pairs on PowerPoint® slides. Each slide contains two images from the same subject randomly arranged so that the grader did not know whether the slide with the two treated side images was presented before or after the slide with the two non-treated side images. Additionally, while both images on the slide came from the same subject, the grader did not know which image represented the before or after condition.
On each set of slides there was a horizontal, 100 mm line located under each image. This line represents a VAS scale where the far left end is marked as “0.0 mm” and represents “Normal Skin” and the far right end is marked at “100 mm” and represents a “Poor Scar”.
Each of the three graders, comprised of a Board Certified Dermatologist and two Board Certified Plastic Surgeons were asked to view each slide and grade each image by using a mouse to grab the vertical line and place it on the horizontal VAS scale line in a position that indicated his/her professional opinion of the relative condition of the scar observed in the image.
In addition to the clinician graded effectiveness measures, the following patient-reported measures were recorded throughout the study:
Table 3: Self-assessed Scar Improvement Scale
| Rating | Description |
| -1 | Exacerbation of scars |
| 0 | No change in appearance of scars |
| 1 | 1% – 25% improvement in appearance of scars |
| 2 | 25% – 50% improvement in appearance of scars |
| 3 | 50% – 75% improvement in appearance of scars |
| 4 | 75% – 99% improvement in appearance of scars |
Table 4: Subject Global Aesthetic Improvement Scale
| Rating | Description |
| 1 | Very Much Improved: Optimal cosmetic result. |
| 2 | Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal. |
| 3 | Improved: Obvious improvement in appearance from initial condition. |
| 4 | No Change: The appearance is essentially the same as the original condition. |
| 5 | Worse: The appearance is worse than the original condition. |
PRIMARY ENDPOINT RESULTS
From the evaluation of the patient data collected during the study, the mean difference in VAS scores on the treatment side was found to be greater than the mean difference in VAS scores on the control side. This result indicates that the SkinStylus SteriLock® MicroSystem was found to improve the appearance of abdominal scars, measured using the VAS scar scoring system. The Minimal Clinically Important Difference (MCID) has been established as an improvement of at least 10 mm out of 100 mm (the entire VAS length).
The primary endpoint was established as a 10 mm (10 mm is the MCID for the VAS) improvement in the treatment side of the scar using the 100 mm validated VAS scale observed by at least 2 out of 3 blinded graders compared to the non-treatment side. Out of the 30 abdomen subjects that completed the trial and had their abdomen treated, 22 subjects had at least a 10 mm improvement, compared to the non-treated side, according to at least 2 of the 3 blinded evaluators. This results in a responder rate of 73% with 95% CI from 58% to 89%.
The visual improvements seen in the photo grading results after only 90 days after the last treatment, were considered to be clinically meaningful as the non-treatment side was also graded and statistically compared against the treatment side results.
Table 5: Responder rates by Fitzpatrick Skin Type according to VAS improvement of 10mm Minimum Clinically Important Difference (MCID) by at least 2 out of 3 graders.
| Fitzpatrick Skin Type | # of subjects in Fitzpatrick Skin Type | # of responders | Percent responding | 95% CI for responder rate (%) |
| Skin Type I to III | 18 | 12 | 67% | (45, 88) |
| Skin Type IV to VI | 12 | 10 | 83% | (62,100) |
| | | | | | | | | |
TABLE 6: RESPONDER RATES BY AGE GROUP ACCORDING TO VAS IMPROVEMENT OF 10MM MINIMUM CLINICALLY IMPORTANT DIFFERENCE (MCID) BY AT LEAST 2 OUT OF 3 GRADERS.
| Age Group | # of subjects in age group | # of responders | Percent responding | 95% CI for responder rate (%) |
| 21 to 40 years old | 9 | 8 | 89% | (68, 100) |
| 41 to 50 years old | 10 | 7 | 70% | (42, 99) |
| 51 to 60 years old | 10 | 7 | 64% | (35, 92) |
TABLE 7: RESPONDER RATES BY AGE OF SCAR GROUP ACCORDING TO VAS IMPROVEMENT OF 10MM MINIMUM CLINICALLY IMPORTANT DIFFERENCE (MCID) BY AT LEAST 2 OUT OF 3 GRADERS.
| Age of scar | # of subjects with scar in age range | # of responders | Percent responding | 95% CI for responder rate (%) |
| 0 to 105 months old | 22 | 17 | 77% | (60, 95) |
| 106 to 180 months old | 5 | 3 | 60% | (17,100) |
| 181 to 240 months old | 3 | 2 | 67% | (13,100) |
SECONDARY ENDPOINT RESULTS
The patient survey results for the Self-Assessed Scar Improvement Scale (SASIS) survey and for the Subject Global Aesthetic Improvement Scale (SGAIS) survey are reported in Tables 8 and 9, respectively.
In the SASIS survey, scores of 1, 2, 3, and 4 indicate perceived improvement in the scar appearance (improvement between 1% and 100%), while a score of -1 means the scar appears worse and a score of 0 means the scar appears unchanged. In the SGAIS survey, scores of 1, 2, and 3 indicate perceived improvement in the scar appearance (very much improved, much improved, and improved), while a score of 4 means the scar is unchanged and a score of 5 means the scar appears worse. Both surveys were evaluated as a measure of consistency in the patient results.
Out of the 30 subjects that completed the trial and had their abdomen treated, 28 had SASIS scores of 1 or greater indicating that they were satisfied with the treatment (93% with 95% CI from 84% to 100 %.)
Out of the 30 subjects that completed the trial and had their abdomen treated, 19 had SASIS scores of 3 or greater indicating they had seen a scar improvement higher than 50% (63% with 95% CI from 46% to 81 %.)
Out of the 30 subjects that completed the trial and had their abdomen treated, 27 had SGAIS of 3 or lower indicated that they were satisfied with the treatment (90% with 95% CI from 79% to 100%.
Both surveys corroborated the results that patients were satisfied and saw improvement in the scar appearance after the three SkinStylus SteriLock® MicroSystem treatments.
Table 8. SASIS Survey Results
| | Rating |
| | -1 | 0 | 1 | 2 | 3 | 4 |
| Number of subjects | 0 | 2 | 5 | 4 | 13 | 6 |
| Percentage of subjects (%) | 0 | 6 | 17 | 13 | 43 | 20 |
Table 9. SGAIS Survey Results
| | Rating |
| | 1 | 2 | 3 | 4 | 5 |
| Number of subjects | 6 | 8 | 13 | 3 | 0 |
| Percentage of subjects (%) | 20 | 27 | 43 | 10 | 0.00 |
Safety Information and Adverse Events Results
Safety information (including images taken before and after treatment) was collected throughout the study during each subsequent visit via patient interviews. Patients were encouraged to write down their symptoms. Additionally, patients were contacted by a study team member within 6 hours after each treatment. Common treatment responses are side effects that result from treatment which resolve on the order of days. Common treatment responses that persist were defined and categorized as adverse events when assessed by the investigator at the next visit. Subjects were informed of the following potential common treatment responses in the informed consent process: skin will be red and flushed similar to a moderate sunburn, skin tightness and mild sensitivity to the touch, redness, burning, tingling, stinging, itching, and/ or scaling/dryness, edema (swelling), tenderness/discomfort, a possibility of developing an infection (an increase in redness, warmth, itching, or pus formation). Adverse events were assessed by the investigator at each subsequent visit. At the 6-month post-treatment visit, no adverse events persisted.
SAFETY ENDPOINT: REPORTED SYMPTOMS NOT DEFINED AS ADVERSE EVENTS
Scabbing/peeling: There were 2 out of 30 (7%) subjects who completed the trial and had their abdomen treated who presented scabbing/peeling symptoms that lasted up to 6 days after treatment.
Dryness: There were 4 out of 30 (13%) subjects who completed the trial and had their abdomen treated that presented dryness symptoms that lasted up to 8 days after treatment.
Discomfort: There were 2 out of 30 (7%) subjects who completed the trial and had their abdomen treated that presented discomfort symptoms that lasted up to 2 hours after treatment.
Redness/Swelling: There were 6 out of 30 (20%) subjects who completed the trial and had their abdomen treated that presented redness/swelling symptoms that lasted up to 4 days after treatment.
Total reported symptoms that were not defined adverse events: There were 10 out of 30 subjects who completed the trial and had their abdomen treated that experienced events not defined as adverse events. The incidence of reported symptoms that were not defined as adverse events was 33% with 95% CI from 17% to 50%.
Adverse Events: There were 2 out of 34 subjects who completed the trial and presented adverse events (hyperpigmentation- one subject Fitzpatrick Skin Type II and one subject Fitzpatrick Skin Type III). The incidence of adverse events (hyperpigmentation) was 6% with 95% CI from 0% to 14% in the 34 subjects that completed the trial. As stated above, at the 90 day after initial treatment visit, 2 subjects (2/34, 5.8%) reported hyperpigmentation in the area of the treated side of the scar that had persisted since treatment on day 31. However, at the 180 day safety visit, both subjects reported that the hyperpigmentation had resolved. This hyperpigmentation adverse event that resolved within the six month safety period was not unexpected, as similar reports of hyperpigmentation that resolves within six months has been reported in the literature5. No other patient reported any other adverse event and the investigators did not observe any other adverse event when examining the subject as well as the images taken before and after each treatment visit.
REFERENCES
1 Fearmonti R, Bond J, Erdmann D, Levinson H. A Review of Scar Scales and Scar Measuring Devices. Eplasty. 2010;10:e43.
2 Duncan, Jonathan & S Bond, Jeremy & Mason, Tracey & Ludlow, Anna & Cridland, Peter & O’Kane, Sharon & Ferguson, Mark. (2006). Visual Analogue Scale Scoring and Ranking: A Suitable and Sensitive Method for Assessing Scar Quality?. Plastic and reconstructive surgery. 118. 909-18.
3 Micomonaco, Damian C.; Fung, Kevin; Mount, Gillian; Franklin, Jason; Yoo, John; Brandt, Michael; Moore, Corey C.; Doyle, Philip C. (2009). Development of a New Visual Analogue Scale for the Assessment of Area Scars. Jr of Otolaryngology Head & Neck Surgery. Feb 2009, Vol. 38 Issue 1, p77-89.
4 Piyush Durani, D.A. McGrouther, M.W.J. Ferguson, (2009) Current scales for assessing human scarring: A review. Journal of Plastic, Reconstructive & Aesthetic Surgery. Volume 62, Issue 6, Pages 713-720.
5 Hou A, Cohen B, Haimovic A, Elbuluk N. Microneedling: a comprehensive review. Dermatol Surg. 2017;43(3):321–39 (PubMed PMID: 27755171).
