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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 Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : December 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : July 25, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars

Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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.

  2. 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



Secondary Outcome Measures :
  1. 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)


  2. 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

  3. 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02646917


Locations
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United States, Texas
Stephens & Associates
Richardson, Texas, United States, 45081
Sponsors and Collaborators
Bellus Medical, LLC
Investigators
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Principal Investigator: Thomas J Stephens, Ph.D Thomas J. Stephens & Associates, Inc.
More Information
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Responsible Party: Bellus Medical, LLC
ClinicalTrials.gov Identifier: NCT02646917    
Other Study ID Numbers: Bellmed001
First Posted: January 6, 2016    Key Record Dates
Results First Posted: July 21, 2021
Last Update Posted: July 21, 2021
Last Verified: June 2021
Additional relevant MeSH terms:
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Acne Vulgaris
Atrophy
Acneiform Eruptions
 Skin Diseases
Sebaceous Gland Diseases
Pathological Conditions, Anatomical