Back to resultsSkinPen Efficacy on Acne Scars on the Face and/or Back
Primary Purpose
Atrophic Acne Scar
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aesthetic Microneedling Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Atrophic Acne Scar
Eligibility Criteria
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.
Sites / Locations
- Stephens & Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
SkinPen II
SkinPen Precision
Arm Description
Three treatments using SkinPen II aesthetic microneedling device to each patient, with each treatment spaced one month apart.
Three treatments using SkinPen Precision aesthetic microneedling device to each patient, with each treatment spaced one month apart.
Outcomes
Primary Outcome Measures
Severity of Acne Scars
Goodman and Baron's Qualitative grading system. Possible scores range from 1 = mild to 4 = severe.
Clinician's Global Aesthetic Improvement Assessment (CGAIS)
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
Photo Grading of Acne Scar Assessment
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)
Subject Self-Assessment Using SASIS
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
Subject Self-Assessment Using Global Aesthetic Improvement Scale (SGAIS)
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02646917
Brief Title
SkinPen Efficacy on Acne Scars on the Face and/or Back
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 Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
July 25, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bellus Medical, LLC
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophic Acne Scar
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SkinPen II
Arm Type
Active Comparator
Arm Description
Three treatments using SkinPen II aesthetic microneedling device to each patient, with each treatment spaced one month apart.
Arm Title
SkinPen Precision
Arm Type
Active Comparator
Arm Description
Three treatments using SkinPen Precision aesthetic microneedling device to each patient, with each treatment spaced one month apart.
Intervention Type
Procedure
Intervention Name(s)
Aesthetic Microneedling Treatment
Intervention Description
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.
Primary Outcome Measure Information:
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
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
Secondary Outcome Measure Information:
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
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
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas J Stephens, Ph.D
Organizational Affiliation
Thomas J. Stephens & Associates, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stephens & Associates
City
Richardson
State/Province
Texas
ZIP/Postal Code
45081
Country
United States
12. IPD Sharing Statement
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SkinPen Efficacy on Acne Scars on the Face and/or Back
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