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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
Last Update Posted : October 2, 2017
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 Device: SkinPen 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 : 65 participants
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
Experimental: SkinPenTreatment
3 SkinPen treatments to each patient, each one month apart.
 Device: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

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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
Last Update Posted: October 2, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Acne Vulgaris
Cicatrix
Atrophy
Acneiform Eruptions
Skin Diseases
 Sebaceous Gland Diseases
Fibrosis
Pathologic Processes
Pathological Conditions, Anatomical