Trial Outcomes & Findings for The Clinical Efficacy And Safety Of SkinStylus Microneedling System (NCT NCT03366194)

NCT ID: NCT03366194

Last Updated: 2022-05-11

Results Overview

The Visual Analog Scale Scar Scoring System (VAS Scar Scale) is a validated scar assessment scale with a minimum scar improvement value of 0.0 cm on one end of a 10.0 cm long line and 10.0 cm on the other end. The 0.0 cm represents "no change" in the appearance of the scar while 10.0 cm represents "complete resolution" of the scar. A panel of 3 expert graders viewed images of the treatment area and the control area before treatment and 90 days after the last treatment. The difference between the measurements taken at baseline and measurements taken two weeks following the end of the treatment of the treatment area was calculated for each participant, for each grader. The difference of all three graders analysis for each subject was averaged. Those participants with a VAS score on the treatment side that met the MCID of an improvement of at least 1.0 cm were identified in the results as "responders". A higher score is a better outcome.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 36 participants
• Primary outcome timeframe: 90 days from date of last treatment
• Results posted on: 2022-05-11

Participant Flow

Participant milestones

Measure	SkinStylus Sterilock System Intervention Each subject shall have a relatively homogenous section of the total scar divided into two relatively equal sides. One side shall be treated with SkinStylus Sterilock System and the other not treated. The side that is chosen for treatment remains constant. The side that is chosen is done so randomly and prior to meeting the subject via a coin flip randomization. SkinStylus Sterilock System: Microneedling device will be used to treat ventral hypertrophic scars.
Overall Study STARTED	36
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure

SkinStylus Sterilock System Intervention Each subject shall have a relatively homogenous section of the total scar divided into two relatively equal sides. One side shall be treated with SkinStylus Sterilock System and the other not treated. The side that is chosen for treatment remains constant. The side that is chosen is done so randomly and prior to meeting the subject via a coin flip randomization. SkinStylus Sterilock System: Microneedling device will be used to treat ventral hypertrophic scars.

Overall Study Lost to Follow-up

2

Baseline Characteristics

The Clinical Efficacy And Safety Of SkinStylus Microneedling System

Baseline characteristics by cohort

Measure	Experimental n=36 Participants Each subject shall have a relatively homogenous section of the total scar divided into two relatively equal sides. One side shall be treated with SkinStylus Sterilock System and the other not treated. The side that is chosen for treatment remains constant. The side that is chosen is done so randomly and prior to meeting the subject via a coin flip randomization. SkinStylus Sterilock System: Microneedling device will be used to treat ventral hypertrophic scars.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	41 Years STANDARD_DEVIATION 3 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	9 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	36 participants n=5 Participants
Chest vs abdomen	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 90 days from date of last treatment

The Visual Analog Scale Scar Scoring System (VAS Scar Scale) is a validated scar assessment scale with a minimum scar improvement value of 0.0 cm on one end of a 10.0 cm long line and 10.0 cm on the other end. The 0.0 cm represents "no change" in the appearance of the scar while 10.0 cm represents "complete resolution" of the scar.

A panel of 3 expert graders viewed images of the treatment area and the control area before treatment and 90 days after the last treatment. The difference between the measurements taken at baseline and measurements taken two weeks following the end of the treatment of the treatment area was calculated for each participant, for each grader. The difference of all three graders analysis for each subject was averaged. Those participants with a VAS score on the treatment side that met the MCID of an improvement of at least 1.0 cm were identified in the results as "responders". A higher score is a better outcome.

Outcome measures

Measure

Experimental n=34 Participants Each subject shall have a relatively homogenous section of the total scar divided into two relatively equal sides. One side shall be treated with SkinStylus Sterilock System and the other not treated. The side that is chosen for treatment remains constant. The side that is chosen is done so randomly and prior to meeting the subject via a coin flip randomization. SkinStylus Sterilock System: Microneedling device will be used to treat ventral hypertrophic scars.

Number of Participants With Improvement Assessed Using the VAS Scar Scoring System

22 Participants

SECONDARY outcome

Timeframe: 90 days from date of last treatment

The Self-Assessed Scar Improvement Scale is a validated 6-point scale (-1 to 4) describing the patient's opinion regarding the overall improvement of the scar after treatment with "4" constituting the patient believing that the scar had a "75%-99%" improvement, "3" constituting a "50%-75%" improvement, "2" constituting a "25%-50%" improvement, "1" constituting a "1%-25%" improvement, "0" constituting "no change", and "-1" constituting an "exacerbation of the scar's appearance". A higher score means a better outcome.

Outcome measures

Measure

Experimental n=34 Participants Each subject shall have a relatively homogenous section of the total scar divided into two relatively equal sides. One side shall be treated with SkinStylus Sterilock System and the other not treated. The side that is chosen for treatment remains constant. The side that is chosen is done so randomly and prior to meeting the subject via a coin flip randomization. SkinStylus Sterilock System: Microneedling device will be used to treat ventral hypertrophic scars.

Number of Patients Self-Reporting Improvement Using the Validated Self-Assessed Scar Improvement Scale Satisfaction Survey

28 Participants

Adverse Events

SkinStylus Sterilock System Intervention

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure

SkinStylus Sterilock System Intervention n=34 participants at risk Each subject shall have a relatively homogenous section of the total scar divided into two relatively equal sides. One side shall be treated with SkinStylus Sterilock System and the other not treated. The side that is chosen for treatment remains constant. The side that is chosen is done so randomly and prior to meeting the subject via a coin flip randomization. SkinStylus Sterilock System: Microneedling device will be used to treat ventral hypertrophic scars.

Skin and subcutaneous tissue disorders Hyperpigmentation transient

5.9% 2/34 • Number of events 2 • 6 months

Additional Information

Study Coordinator

Esthetic Education LLC

Phone: (480) 656-2251

Email: Support@skinstylus.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place