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SkinPen Efficacy on Acne Scars on the Face and/or Back

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ClinicalTrials.gov Identifier: NCT02646917
Recruitment Status : Completed
First Posted : January 6, 2016
Results First Posted : July 21, 2021
Last Update Posted : July 21, 2021
Sponsor:
Information provided by (Responsible Party):
Bellus Medical, LLC

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Atrophic Acne Scar
Intervention Procedure: Aesthetic Microneedling Treatment
Enrollment 41
Recruitment Details 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.
Pre-assignment Details Only participants who met eligibility requirements were enrolled into the study and assigned to groups.
Arm/Group Title SkinPen II SkinPen Precision
Hide Arm/Group Description

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.

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.
Period Title: Overall Study
Started 21 20
Completed 21 20
Not Completed 0 0
Arm/Group Title SkinPen II SkinPen Precision Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 21 20 41
Hide Baseline Analysis Population Description
The analysis population includes all participants completing the study.
Age, Customized   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Completed Subjects Number Analyzed 21 participants 20 participants 41 participants
44.2  (11.4) 43.8  (12.7) 44  (11.9)
[1]
Measure Description: Men and women 18-60 years of age in generally good health were enrolled after satisfying the inclusion and exclusion criteria. Their age, race, and ethnicity were recorded.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 20 participants 41 participants
Female
15
  71.4%
13
  65.0%
28
  68.3%
Male
6
  28.6%
7
  35.0%
13
  31.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 20 participants 41 participants
Hispanic or Latino
7
  33.3%
6
  30.0%
13
  31.7%
Not Hispanic or Latino
14
  66.7%
14
  70.0%
28
  68.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 20 participants 41 participants
American Indian or Alaska Native
1
   4.8%
1
   5.0%
2
   4.9%
Asian
6
  28.6%
3
  15.0%
9
  22.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
  19.0%
6
  30.0%
10
  24.4%
White
10
  47.6%
10
  50.0%
20
  48.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants 20 participants 41 participants
21 20 41
[1]
Measure Description: Participants were treated and evaluated in Dallas, Texas, USA.
1.Primary Outcome
Title Severity of Acne Scars
Hide Description Goodman and Baron's Qualitative grading system. Possible scores range from 1 = mild to 4 = severe.
Time Frame Baseline, 1 month post treatment, and 6 months post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all participants who completed the study.
Arm/Group Title Skinpen ll Skinpen Precision
Hide Arm/Group Description:
Patients treated with the SkinPen II micro-needling device at 1 day, 30 days and 60 days.
Patients treated with the SkinPen Precision micro-needling device at 1 day, 30 days and 60 days.
Overall Number of Participants Analyzed 21 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 3.19  (.40) 3.10  (.31)
1-Month Post Treatment 2.81  (.68) 2.90  (.55)
6-Months Post-Treatment 2.62  (.59) 2.70  (.57)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Skinpen ll, Skinpen Precision
Comments Goodman and Baron's qualitative acne scar severity scores. Calculated from Wilcoxon signed-rank test. Testing hypothesis is that the mean change from baseline is equal to zero.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.008
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Primary Outcome
Title Clinician's Global Aesthetic Improvement Assessment (CGAIS)
Hide Description

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
Time Frame 1 month post treatment, and 6 months post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all participants who completed the study.
Arm/Group Title Skinpen ll Skinpen Precision
Hide Arm/Group Description:
Patients treated with the SkinPen II micro-needling device at 1 day, 30 days and 60 days.
Patients treated with the SkinPen Precision micro-needling device at 1 day, 30 days and 60 days.
Overall Number of Participants Analyzed 21 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
1-Month Post Treatment 3.10  (.77) 3.20  (.77)
6-Months Post-Treatment 2.76  (.77) 2.70  (.86)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Skinpen ll, Skinpen Precision
Comments Null hypothesis 4 (no change).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Wilcoxen signed-rank test
Comments [Not Specified]
3.Secondary Outcome
Title Photo Grading of Acne Scar Assessment
Hide Description

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)
Time Frame Day 1 (Baseline), Day 30, Day 60, 1-Month post treatment and 6 Month post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analyxed population includes all participants who completed the study.
Arm/Group Title SkinPen II SkinPen Precision
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 21 20
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
Baseline 2.81  (0.58) 2.80  (0.52)
Day 30 2.55  (0.59) 2.78  (0.57)
Day 60 2.67  (0.53) 2.70  (0.55)
1-Month post treatment 2.71  (0.75) 2.68  (0.49)
6-Month post treatment 2.81  (0.68) 2.35  (0.59)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SkinPen II, SkinPen Precision
Comments Calculated from Wilcoxon signed-rank test. The testing hypothesis is that the mean change from baseline is equal to zero
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Subject Self-Assessment Using SASIS
Hide Description

Subject 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
Time Frame One Month Post Treatment, 6 Month Post Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SkinPen II SkinPen Precision
Hide Arm/Group Description:

Three treatments using SkinPen II aesthetic microneedling device to each patient, with each treatment spaced one month apart.

Aesthetic Microneedling Treatment: 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.

Three treatments using SkinPen Precision aesthetic microneedling device to each patient, with each treatment spaced one month apart.

Aesthetic Microneedling Treatment: 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 Number of Participants Analyzed 21 20
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
1-Month Post treatment 1.67  (1.49) 1.65  (0.93)
6-Month Post treatment 1.71  (1.23) 1.70  (1.08)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SkinPen II, SkinPen Precision
Comments Calculated from Wilcoxon signed-rank test. The testing hypothesis is that the mean score is equal to 0 (no change in the appearance of acne scars).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Subject Self-Assessment Using Global Aesthetic Improvement Scale (SGAIS)
Hide Description

The 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
Time Frame 1-Month Post Treatment and 6- Month Post Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SkinPen II SkinPen Precision
Hide Arm/Group Description:

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.

20 Subjects, 3 SkinPen II 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 Number of Participants Analyzed 21 20
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
1-Month Post Treatment 2.71  (1.06) 2.85  (0.75)
6- Month Post Treatment 0.91  (1.00) 2.50  (0.83)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SkinPen II, SkinPen Precision
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Calculated from Wilcoxon signed-rank test. Testing hypothesis is that the mean score is equal to 4 (no change).
Time Frame 1 year, 6 months
Adverse Event Reporting Description Adverse Events (AEs) were defined as any untoward medical occurrence regardless of causal relationship with the test article.
 
Arm/Group Title SkinPen II SkinPen Precision
Hide Arm/Group Description

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.

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.
All-Cause Mortality
SkinPen II SkinPen Precision
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)      1/20 (5.00%)    
Hide Serious Adverse Events
SkinPen II SkinPen Precision
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/21 (0.00%)      0/20 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
SkinPen II SkinPen Precision
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/21 (4.76%)      2/20 (10.00%)    
Pregnancy, puerperium and perinatal conditions     
Pregnancy *  0/21 (0.00%)  0 1/20 (5.00%)  1
Skin and subcutaneous tissue disorders     
Anthrapod bite * [1]  1/21 (4.76%)  1 0/20 (0.00%)  0
Erythema (face) *  0/21 (0.00%)  0 1/20 (5.00%)  1
Oedema (face) *  0/21 (0.00%)  0 1/20 (5.00%)  1
Pruritus (face) *  0/21 (0.00%)  0 1/20 (5.00%)  1
Skin striae (forehead and both sides of face) *  0/21 (0.00%)  0 1/20 (5.00%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Brown recluse - inner right thigh
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Thomas Hitchcock, PhD
Organization: Crown Laboratories, Inc.
Phone: 8883723982
EMail: THitchcock@crownlaboratories.com
Layout table for additonal information
Responsible Party: Bellus Medical, LLC
ClinicalTrials.gov Identifier: NCT02646917    
Other Study ID Numbers: Bellmed001
First Submitted: December 21, 2015
First Posted: January 6, 2016
Results First Submitted: September 30, 2019
Results First Posted: July 21, 2021
Last Update Posted: July 21, 2021