We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE December 21, 2015
First Posted Date  ICMJE January 6, 2016
Results First Submitted Date  ICMJE September 30, 2019
Results First Posted Date  ICMJE July 21, 2021
Last Update Posted Date July 21, 2021
Study Start Date  ICMJE December 2015
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2021)
  • Severity of Acne Scars [ Time Frame: 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.
  • Clinician's Global Aesthetic Improvement Assessment (CGAIS) [ Time Frame: 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
Original Primary Outcome Measures  ICMJE
 (submitted: January 4, 2016)
Assessment of Change of Acne Scar Severity using Goodman and Baron's quantitative and qualitative grading system [ Time Frame: Baseline, 1 month post treatment, and 6 month post treatment ]
Assessment of acne scar severity using Goodman and Baron's quantitative and qualitative grading system at baseline, 1 month post treatment and 6 months post treatment.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2021)
  • Photo Grading of Acne Scar Assessment [ Time Frame: 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.
    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)
  • Subject Self-Assessment Using SASIS [ Time Frame: 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):
    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
  • Subject Self-Assessment Using Global Aesthetic Improvement Scale (SGAIS) [ Time Frame: 1-Month Post Treatment and 6- Month Post Treatment ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2016)
Assessment of Change of Facial Wrinkling using a modified Griffiths' 10-point scale [ Time Frame: Baseline, 1 month post treatment, and 6 month post treatment ]
Assessment of facial wrinkling at baseline, 1-month post treatment, and 6-months post treatment using a modified Griffiths' 10-point scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SkinPen Efficacy on Acne Scars on the Face and/or Back
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atrophic Acne Scar
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Active Comparator: SkinPen II
    Three treatments using SkinPen II aesthetic microneedling device to each patient, with each treatment spaced one month apart.
    Intervention: Procedure: Aesthetic Microneedling Treatment
  • Active Comparator: SkinPen Precision
    Three treatments using SkinPen Precision aesthetic microneedling device to each patient, with each treatment spaced one month apart.
    Intervention: Procedure: Aesthetic Microneedling Treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 30, 2021)
41
Original Estimated Enrollment  ICMJE
 (submitted: January 4, 2016)
20
Actual Study Completion Date  ICMJE July 25, 2017
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02646917
Other Study ID Numbers  ICMJE Bellmed001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Bellus Medical, LLC
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Bellus Medical, LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas J Stephens, Ph.D Thomas J. Stephens & Associates, Inc.
PRS Account Bellus Medical, LLC
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP