Cicatrix, Hypertrophic
Conditions
Brief summary
The purpose of the trial is to provide objective evidence the SkinStylus may be used safely and effectively for the treatment of ventral torso hypertrophic scars.
Detailed description
1. The SkinStylus has been designated as a non-significant risk and therefore will be granted an Investigational Device Exemption (IDE). There are no meaningful changes to the SkinStylus® instructions for use and specifically no new risks will be introduced. 2. Each participant shall have at least one suitable ventral torso hypertropic scar of sufficient length that it may be easily visualized in two halfs. At the conclusion of the trial all participants shall be provided with a cross over treatment on the non-treated portion of the scar identical to that which was provided within the trial for the purpose of evening the ventral torso hypertrophic scar. This is entirely voluntary and participants may decline the treatment if they wish.
Interventions
DEVICESkinStylus Sterilock System
Microneedling device will be used to treat ventral hypertrophic scars.
Sponsors
Esthetic Education LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
3\. The trial shall be blinded and bias minimized in that three (3) physicians who are either dermatologists or plastic surgeons (and not affiliated with the trial or Esthetic Education LLC) shall review the baseline and treatment photographs and score them using the VAS scale (Visual Analogue Scale).
Intervention model description
Each participant shall have at least one suitable ventral torso hypertropic scar of sufficient length that it may be easily visualized in two halfs. At the conclusion of the trial all participants shall be provided with a cross over treatment on the non-treated portion of the scar identical to that which was provided within the trial for the purpose of evening the ventral torso hypertrophic scar.
Eligibility
Sex/Gender
ALL
Age
23 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. at least 23 years old 2. shall have at least one suitable ventral torso hypertropic scar of sufficient length that it may be easily visualized in two halfs. 3. The scar(s) must present along a flat surface suitable for application of the SkinStylus® device and consistent medical photography.
Exclusion criteria
1. Pregnancy or chance of pregnancy 2. Currently taking Coumadin/Warfarin® or heparin 3. Diagnosis of any type of bleeding disorder 4. Any history of keloid formation 5. Lidocaine, tetracaine, prilocaine, bupivacaine, or benzocaine hypersensitivity 6. Diagnosis of mental disorders requiring inpatient treatment 7. Presence of metal implants around the proposed treatment areas 8. Diagnosis of any undefined wasting disease (Cachexia for example) 9. Diagnosis of an active infection in the treatment area other than mild acne 10. Diagnosis of the presence of tumors or those who are being treated by chemotherapy or radiation therapy 11. Diagnosis of severe cardiovascular and cerebrovascular disease 12. Diagnosis of renal failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Improvement Assessed Using the VAS Scar Scoring System | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Self-Reporting Improvement Using the Validated Self-Assessed Scar Improvement Scale Satisfaction Survey | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental 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. | 36 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Experimental |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants |
| Age, Continuous | 41 Years STANDARD_DEVIATION 3 |
| Chest vs abdomen | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 22 Participants |
| Region of Enrollment United States | 36 participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 34 |
| other Total, other adverse events | 2 / 34 |
| serious Total, serious adverse events | 0 / 34 |
Outcome results
Primary
Number of Participants With Improvement Assessed Using the VAS Scar Scoring System
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.
Time frame: 90 days from date of last treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental | Number of Participants With Improvement Assessed Using the VAS Scar Scoring System | 22 Participants |
Secondary
Number of Patients Self-Reporting Improvement Using the Validated Self-Assessed Scar Improvement Scale Satisfaction Survey
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.
Time frame: 90 days from date of last treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental | Number of Patients Self-Reporting Improvement Using the Validated Self-Assessed Scar Improvement Scale Satisfaction Survey | 28 Participants |