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

• Sponsor: Bellus Medical, LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02646917
• Collaborator: (none)
• Enrollment: 41
• Location: 1
• Arms: 2
• Duration (Months): 19.8
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

This single-center, clinical trial will take place over a 90 day course followed by 1-month and 6-month post treatment visits to assess the efficacy and tolerability of the SkinPen device when used on both men and women on the face and/or back.

Condition or Disease	Intervention/Treatment	Phase
Atrophic Acne Scar	Procedure: Aesthetic Microneedling Treatment	N/A

Detailed Description

At least 20 subjects of varying Fitzpatrick skin types will be admitted to the trial for treatment on their moderate to severe acne scars on the face and/or back. Implementation of needle depths ranging from 0.25 mm to 2.0 mm will depend on severity of scars and their location. Each subject will undergo 3 treatments in 30 day increments and will take pre-treatment images as well as 1-month and 6-months post treatment images. Assessment will be based on the Goodman and Baron's grading system, the Clinician's Global Aesthetic Improvement Scale, as well as a self-assessment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 41 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Single-Center Trial to Evaluate the Efficacy and Tolerability of SkinPen on Male and Female Subjects' Acne Scars on the Face and/or Back
• Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Jul 25, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: SkinPen II Three treatments using SkinPen II aesthetic microneedling device to each patient, with each treatment spaced one month apart.	Procedure: 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.
Active Comparator: SkinPen Precision Three treatments using SkinPen Precision aesthetic microneedling device to each patient, with each treatment spaced one month apart.	Procedure: 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.

Outcome Measures

Primary Outcome Measures

1. Severity of Acne Scars [Baseline, 1 month post treatment, and 6 months post treatment]

   Goodman and Baron's Qualitative grading system. Possible scores range from 1 = mild to 4 = severe.

2. Clinician's Global Aesthetic Improvement Assessment (CGAIS) [1 month post treatment, and 6 months post treatment]

   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

Secondary Outcome Measures

1. Photo Grading of Acne Scar Assessment [Day 1 (Baseline), Day 30, Day 60, 1-Month post treatment and 6 Month post treatment]

   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. - 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). - 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)

2. Subject Self-Assessment Using SASIS [One Month Post Treatment, 6 Month Post Treatment]

   Subject self-assessment was completed in 2 steps for self-assessed scar improvement scale (SASIS) and subject global aesthetic improvement scale (SGAIS): Based on a live assessment (subjects were provided with a hand mirror for assessment) of the subject while referring to pre-treatment images. 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% - 25% improvement in the appearance of acne scars 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

3. Subject Self-Assessment Using Global Aesthetic Improvement Scale (SGAIS) [1-Month Post Treatment and 6- Month Post Treatment]

   The following rating scale was used for SGAIS: Rating and Description - Very much improved: Optimal cosmetic result - Much improved: Marked improvement in appearance from the initial condition, but not completely optimal - Improved: Obvious improvement in appearance from initial condition -No change: The appearance is essentially the same as the original condition - Worse: The appearance is worse than the original condition

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Men and women 18 to 60 years of age.

• Subjects in good health.

• Approximately 5 to 10 atrophic acne scars of mixed types (boxcar and/or rolling scars with some icepick scars allowed) on face and/or back that are moderate to severe.

• Desire correction of his/her acne scarring.

• Subjects of child bearing potential must take a urine pregnancy test and must test negative.

• Subjects willing to sign a photography release.

• Willingness to cooperate and participate by following study requirements.

Exclusion Criteria:

• Allergies to facial or general skin care products

• Presence of an active systemic or local skin disease.

• Severe solar elastosis.

• Sensitivity to topical lidocaine.

• Recent history of significant trauma to the face (< 6 months).

• Significant scarring other than acne scars in treated area(s).

• Severe of cystic active and clinically significant acne on the area(s) to be treated.

• History of systemic granulomatous diseases.

• History of hypertrophic or keloid scars.

• Current cancerous or pre-cancerous lesions in area(s) to be treated.

• Had microdermabrasion or glycolic acid treatment to treatment area(s) within 1 month prior to study participation.

• History of chronic drug or alcohol abuse.

• Current smokers or have smoked in the last 5 years.

• History of cosmetic treatments: Skin tightening within last year, injectable filler of any type within the last year, neurotoxins within the last 3 months, ablative resurfacing laser treatments, non-ablative, rejuvanative laser treatments in last 6 months, chemical peel, dermabrasion, non-ablative laser or fractional laser resurfacing of face and neck within the last 4 weeks.

• History of certain prescription medications (accutane or other retinoids, topical retinoids, prescription strength skin lightening devices, anti-wrinkle, skin lightening devices, antiplatelet agents/Anticoagulants, and/or psychiatric drugs).

• Nursing, pregnant, or planning to become pregnant during study.

• Current or pre-existing dermatologic diseases on the face or body (psoriasis, rosacea, eczema, etc.)

• History of immunosupression/immune deficiency disorders.

• Current or history of uncontrolled disease such as asthma, diabetes, hyperthyroidism, etc.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stephens & Associates	Richardson	Texas	United States	45081

Sponsors and Collaborators

• Bellus Medical, LLC

Investigators

• Principal Investigator: Thomas J Stephens, Ph.D, Thomas J. Stephens & Associates, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bellus Medical, LLC
• ClinicalTrials.gov Identifier: NCT02646917
• Other Study ID Numbers: Bellmed001
• First Posted: Jan 6, 2016
• Last Update Posted: Jul 21, 2021
• Last Verified: Jun 1, 2021

• Additional relevant MeSH terms: Acne Vulgaris; Atrophy

Study Results

Participant Flow

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 Detail	Only participants who met eligibility requirements were enrolled into the study and assigned to groups.

Arm/Group Title	SkinPen II	SkinPen Precision
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

Baseline Characteristics

Arm/Group Title	SkinPen II	SkinPen Precision	Total
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 Participants	21	20	41
Age, Customized (years) [Mean (Standard Deviation) ]
Completed Subjects	44.2 (11.4)	43.8 (12.7)	44 (11.9)
Sex: Female, Male (Count of Participants)
Female	15 71.4%	13 65%	28 68.3%
Male	6 28.6%	7 35%	13 31.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	7 33.3%	6 30%	13 31.7%
Not Hispanic or Latino	14 66.7%	14 70%	28 68.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 4.8%	1 5%	2 4.9%
Asian	6 28.6%	3 15%	9 22%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	4 19%	6 30%	10 24.4%
White	10 47.6%	10 50%	20 48.8%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	21 100%	20 100%	41 100%

Outcome Measures

1. Primary Outcome

Title	Severity of Acne Scars
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

Outcome Measure Data

Analysis Population Description

The analysis population includes all participants who completed the study.

Arm/Group Title	Skinpen ll	Skinpen Precision
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.
Measure Participants	21	20
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)

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
Statistical Test of Hypothesis	p-Value	<0.008
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Primary Outcome

Title	Clinician's Global Aesthetic Improvement Assessment (CGAIS)
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

Outcome Measure Data

Analysis Population Description

The analysis population includes all participants who completed the study.

Arm/Group Title	Skinpen ll	Skinpen Precision
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.
Measure Participants	21	20
1-Month Post Treatment	3.10 (.77)	3.20 (.77)
6-Months Post-Treatment	2.76 (.77)	2.70 (.86)

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
Statistical Test of Hypothesis	p-Value	<.001
	Comments
	Method	Wilcoxen signed-rank test
	Comments

3. Secondary Outcome

Title	Photo Grading of Acne Scar Assessment
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. - 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). - 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

Outcome Measure Data

Analysis Population Description

The analyxed population includes all participants who completed the study.

Arm/Group Title	SkinPen II	SkinPen Precision
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.
Measure Participants	21	20
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)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Skinpen ll, 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
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

4. Secondary Outcome

Title	Subject Self-Assessment Using SASIS
Description	Subject self-assessment was completed in 2 steps for self-assessed scar improvement scale (SASIS) and subject global aesthetic improvement scale (SGAIS): Based on a live assessment (subjects were provided with a hand mirror for assessment) of the subject while referring to pre-treatment images. 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% - 25% improvement in the appearance of acne scars 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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SkinPen II	SkinPen Precision
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.
Measure Participants	21	20
1-Month Post treatment	1.67 (1.49)	1.65 (0.93)
6-Month Post treatment	1.71 (1.23)	1.70 (1.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Skinpen ll, 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
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

5. Secondary Outcome

Title	Subject Self-Assessment Using Global Aesthetic Improvement Scale (SGAIS)
Description	The following rating scale was used for SGAIS: Rating and Description - Very much improved: Optimal cosmetic result - Much improved: Marked improvement in appearance from the initial condition, but not completely optimal - Improved: Obvious improvement in appearance from initial condition -No change: The appearance is essentially the same as the original condition - Worse: The appearance is worse than the original condition
Time Frame	1-Month Post Treatment and 6- Month Post Treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SkinPen II	SkinPen Precision
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.
Measure Participants	21	20
1-Month Post Treatment	2.71 (1.06)	2.85 (0.75)
6- Month Post Treatment	0.91 (1.00)	2.50 (0.83)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Skinpen ll, Skinpen Precision
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments	Calculated from Wilcoxon signed-rank test. Testing hypothesis is that the mean score is equal to 4 (no change).

Adverse Events

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
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		1/20 (5%)
Serious Adverse Events
	SkinPen II		SkinPen Precision
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	SkinPen II		SkinPen Precision
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/21 (4.8%)		2/20 (10%)
Pregnancy, puerperium and perinatal conditions
Pregnancy	0/21 (0%)	0	1/20 (5%)	1
Skin and subcutaneous tissue disorders
Anthrapod bite	1/21 (4.8%)	1	0/20 (0%)	0
Erythema (face)	0/21 (0%)	0	1/20 (5%)	1
Oedema (face)	0/21 (0%)	0	1/20 (5%)	1
Pruritus (face)	0/21 (0%)	0	1/20 (5%)	1
Skin striae (forehead and both sides of face)	0/21 (0%)	0	1/20 (5%)	1

Limitations/Caveats

[Not Specified]

More Information

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.