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

• 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: Bellus Medical, LLC
• Information provided by (Responsible Party): Bellus Medical, LLC

Tracking Information

• First Submitted Date: December 21, 2015
• First Posted Date: January 6, 2016
• Results First Submitted Date: September 30, 2019
• Results First Posted Date: July 21, 2021
• Last Update Posted Date: July 21, 2021
• Study Start Date: December 2015
• Actual Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

Current Secondary Outcome Measures (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 (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: 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
• 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: Interventional
• Study Phase: Not Applicable
• 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

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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 30, 2021): 41
• Original Estimated Enrollment (submitted: January 4, 2016): 20
• Actual Study Completion Date: July 25, 2017
• Actual Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02646917
• Other Study ID Numbers: Bellmed001
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Bellus Medical, LLC
• Original Responsible Party: Same as current
• Current Study Sponsor: Bellus Medical, LLC
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Bellus Medical, LLC
• Verification Date: June 2021