Trial Outcomes & Findings for SkinPen Efficacy on Acne Scars on the Face and/or Back (NCT NCT02646917)
NCT ID: NCT02646917
Last Updated: 2021-07-21
Results Overview
Goodman and Baron's Qualitative grading system. Possible scores range from 1 = mild to 4 = severe.
COMPLETED
NA
41 participants
Baseline, 1 month post treatment, and 6 months post treatment
2021-07-21
Participant Flow
Pre-screening was conducted by phone to determine eligibility criteria through and IRB-approved script. Followed by in-clinic screening visits conducted between December 7, 2015 and February 19, 2016.
Only participants who met eligibility requirements were enrolled into the study and assigned to groups.
Participant milestones
| Measure |
SkinPen II
21 Subjects, 3 SkinPen II treatments to each patient, each one month apart.
SkinPen II: Treatment of acne scars on the face and/or back at needle depth settings ranging between 0.25 mm to 2.0 mm, depending on severity and location of scarring.
|
SkinPen Precision
20 Subjects, 3 SkinPen precision treatments to each patient, each one month apart.
SkinPen Precision: Treatment of acne scars on the face and/or back at needle depth settings ranging between 0.25 mm to 2.0 mm, depending on severity and location of scarring.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
|
Overall Study
COMPLETED
|
21
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SkinPen Efficacy on Acne Scars on the Face and/or Back
Baseline characteristics by cohort
| Measure |
SkinPen II
n=21 Participants
3 treatments with SkinPen II to each patient, each one month apart.
SkinPen: Treatment of acne scars on the face and/or back at needle depth settings ranging between 0.25 mm to 2.0 mm, depending on severity and location of scarring.
|
SkinPen Precision
n=20 Participants
3 treatments with SkinPen Precision to each patient, each one month apart.
SkinPen: Treatment of acne scars on the face and/or back at needle depth settings ranging between 0.25 mm to 2.0 mm, depending on severity and location of scarring.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Completed Subjects
|
44.2 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
43.8 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
44 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
20 participants
n=7 Participants
|
41 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1 month post treatment, and 6 months post treatmentPopulation: The analysis population includes all participants who completed the study.
Goodman and Baron's Qualitative grading system. Possible scores range from 1 = mild to 4 = severe.
Outcome measures
| Measure |
Skinpen ll
n=21 Participants
Patients treated with the SkinPen II micro-needling device at 1 day, 30 days and 60 days.
|
Skinpen Precision
n=20 Participants
Patients treated with the SkinPen Precision micro-needling device at 1 day, 30 days and 60 days.
|
|---|---|---|
|
Severity of Acne Scars
Baseline
|
3.19 score on a scale
Standard Deviation .40
|
3.10 score on a scale
Standard Deviation .31
|
|
Severity of Acne Scars
1-Month Post Treatment
|
2.81 score on a scale
Standard Deviation .68
|
2.90 score on a scale
Standard Deviation .55
|
|
Severity of Acne Scars
6-Months Post-Treatment
|
2.62 score on a scale
Standard Deviation .59
|
2.70 score on a scale
Standard Deviation .57
|
PRIMARY outcome
Timeframe: 1 month post treatment, and 6 months post treatmentPopulation: The analysis population includes all participants who completed the study.
Clinician's Global Aesthetic Improvement Assessment: minimal score is 1- Very much improved and, maximum score is 5 -Worse: The appearance is worse than the original condition
Outcome measures
| Measure |
Skinpen ll
n=21 Participants
Patients treated with the SkinPen II micro-needling device at 1 day, 30 days and 60 days.
|
Skinpen Precision
n=20 Participants
Patients treated with the SkinPen Precision micro-needling device at 1 day, 30 days and 60 days.
|
|---|---|---|
|
Clinician's Global Aesthetic Improvement Assessment (CGAIS)
1-Month Post Treatment
|
3.10 score on a scale
Standard Deviation .77
|
3.20 score on a scale
Standard Deviation .77
|
|
Clinician's Global Aesthetic Improvement Assessment (CGAIS)
6-Months Post-Treatment
|
2.76 score on a scale
Standard Deviation .77
|
2.70 score on a scale
Standard Deviation .86
|
SECONDARY outcome
Timeframe: Day 1 (Baseline), Day 30, Day 60, 1-Month post treatment and 6 Month post treatmentPopulation: The analyxed population includes all participants who completed the study.
Photo grading of acne scars assessment was done using the following scale \[Karnik J. et al, JAAD 2014, 71 (1)\]: Grade- Term- Description 0 - Clear-- No depression is seen in the treatment area. Macular discoloration may be seen. 1. \- Very mild- - A single depression is easily noticeable with direct lighting (deep). Most or all of the depressions seen are only readily apparent with tangential lighting (shallow). 2. \- Mild-- A few to several, but less than half of all the depressions are easily noticeable with direct lighting(deep). Most of the depressions see are only readily apparent with tangential lighting (Shallow) 3- Moderate-- More than half of the depressions are apparent with direct lighting (deep) 4- Severe-- All or almost all the lesions can be seen with direct lighting (deep)
Outcome measures
| Measure |
Skinpen ll
n=21 Participants
Patients treated with the SkinPen II micro-needling device at 1 day, 30 days and 60 days.
|
Skinpen Precision
n=20 Participants
Patients treated with the SkinPen Precision micro-needling device at 1 day, 30 days and 60 days.
|
|---|---|---|
|
Photo Grading of Acne Scar Assessment
Baseline
|
2.81 Score on a Scale
Standard Deviation 0.58
|
2.80 Score on a Scale
Standard Deviation 0.52
|
|
Photo Grading of Acne Scar Assessment
Day 30
|
2.55 Score on a Scale
Standard Deviation 0.59
|
2.78 Score on a Scale
Standard Deviation 0.57
|
|
Photo Grading of Acne Scar Assessment
Day 60
|
2.67 Score on a Scale
Standard Deviation 0.53
|
2.70 Score on a Scale
Standard Deviation 0.55
|
|
Photo Grading of Acne Scar Assessment
1-Month post treatment
|
2.71 Score on a Scale
Standard Deviation 0.75
|
2.68 Score on a Scale
Standard Deviation 0.49
|
|
Photo Grading of Acne Scar Assessment
6-Month post treatment
|
2.81 Score on a Scale
Standard Deviation 0.68
|
2.35 Score on a Scale
Standard Deviation 0.59
|
SECONDARY outcome
Timeframe: One Month Post Treatment, 6 Month Post TreatmentSubject self-assessment was completed in 2 steps for self-assessed scar improvement scale (SASIS) and subject global aesthetic improvement scale (SGAIS): 1. Based on a live assessment (subjects were provided with a hand mirror for assessment) of the subject while referring to pre-treatment images. 2. Based on a comparison of pre-treatment images to current post-treatment images. Rating of Acne Scars * 1-Exacerbation of acne scars 0 No change in the appearance of acne scars 1. 1% - 25% improvement in the appearance of acne scars 2. 25% - 50% improvement in the appearance of acne scars 3-50% - 75% improvement in the appearance of acne scars 4-75% - 99% improvement in the appearance of acne scars
Outcome measures
| Measure |
Skinpen ll
n=21 Participants
Patients treated with the SkinPen II micro-needling device at 1 day, 30 days and 60 days.
|
Skinpen Precision
n=20 Participants
Patients treated with the SkinPen Precision micro-needling device at 1 day, 30 days and 60 days.
|
|---|---|---|
|
Subject Self-Assessment Using SASIS
1-Month Post treatment
|
1.67 Score on a Scale
Standard Deviation 1.49
|
1.65 Score on a Scale
Standard Deviation 0.93
|
|
Subject Self-Assessment Using SASIS
6-Month Post treatment
|
1.71 Score on a Scale
Standard Deviation 1.23
|
1.70 Score on a Scale
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: 1-Month Post Treatment and 6- Month Post TreatmentThe following rating scale was used for SGAIS: Rating and 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
Outcome measures
| Measure |
Skinpen ll
n=21 Participants
Patients treated with the SkinPen II micro-needling device at 1 day, 30 days and 60 days.
|
Skinpen Precision
n=20 Participants
Patients treated with the SkinPen Precision micro-needling device at 1 day, 30 days and 60 days.
|
|---|---|---|
|
Subject Self-Assessment Using Global Aesthetic Improvement Scale (SGAIS)
1-Month Post Treatment
|
2.71 Score on a Scale
Standard Deviation 1.06
|
2.85 Score on a Scale
Standard Deviation 0.75
|
|
Subject Self-Assessment Using Global Aesthetic Improvement Scale (SGAIS)
6- Month Post Treatment
|
0.91 Score on a Scale
Standard Deviation 1.00
|
2.50 Score on a Scale
Standard Deviation 0.83
|
Adverse Events
SkinPen II
SkinPen Precision
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SkinPen II
n=21 participants at risk
3 SkinPen ll treatments to each patient, each one month apart.
SkinPen ll: Treatment of acne scars on the face and/or back at needle depth settings ranging between 0.25 mm to 2.0 mm, depending on severity and location of scarring.
|
SkinPen Precision
n=20 participants at risk
3 SkinPen treatments to each patient, each one month apart.
SkinPen Precision: Treatment of acne scars on the face and/or back at needle depth settings ranging between 0.25 mm to 2.0 mm, depending on severity and location of scarring.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Anthrapod bite
|
4.8%
1/21 • Number of events 1 • 1 year, 6 months
Adverse Events (AEs) were defined as any untoward medical occurrence regardless of causal relationship with the test article.
|
0.00%
0/20 • 1 year, 6 months
Adverse Events (AEs) were defined as any untoward medical occurrence regardless of causal relationship with the test article.
|
|
Skin and subcutaneous tissue disorders
Erythema (face)
|
0.00%
0/21 • 1 year, 6 months
Adverse Events (AEs) were defined as any untoward medical occurrence regardless of causal relationship with the test article.
|
5.0%
1/20 • Number of events 1 • 1 year, 6 months
Adverse Events (AEs) were defined as any untoward medical occurrence regardless of causal relationship with the test article.
|
|
Skin and subcutaneous tissue disorders
Oedema (face)
|
0.00%
0/21 • 1 year, 6 months
Adverse Events (AEs) were defined as any untoward medical occurrence regardless of causal relationship with the test article.
|
5.0%
1/20 • Number of events 1 • 1 year, 6 months
Adverse Events (AEs) were defined as any untoward medical occurrence regardless of causal relationship with the test article.
|
|
Skin and subcutaneous tissue disorders
Pruritus (face)
|
0.00%
0/21 • 1 year, 6 months
Adverse Events (AEs) were defined as any untoward medical occurrence regardless of causal relationship with the test article.
|
5.0%
1/20 • Number of events 1 • 1 year, 6 months
Adverse Events (AEs) were defined as any untoward medical occurrence regardless of causal relationship with the test article.
|
|
Skin and subcutaneous tissue disorders
Skin striae (forehead and both sides of face)
|
0.00%
0/21 • 1 year, 6 months
Adverse Events (AEs) were defined as any untoward medical occurrence regardless of causal relationship with the test article.
|
5.0%
1/20 • Number of events 1 • 1 year, 6 months
Adverse Events (AEs) were defined as any untoward medical occurrence regardless of causal relationship with the test article.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/21 • 1 year, 6 months
Adverse Events (AEs) were defined as any untoward medical occurrence regardless of causal relationship with the test article.
|
5.0%
1/20 • Number of events 1 • 1 year, 6 months
Adverse Events (AEs) were defined as any untoward medical occurrence regardless of causal relationship with the test article.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place