Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
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
Last Update Posted : October 2, 2017
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
Last Update Posted Date October 2, 2017
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: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current 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
Original Secondary Outcome Measures  ICMJE Same as current
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 Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atrophic Acne Scar
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: SkinPenTreatment
3 SkinPen treatments to each patient, each one month apart.
Intervention: Device: SkinPen
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: January 23, 2017)
65
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
Responsible Party Bellus Medical, LLC
Study Sponsor  ICMJE Bellus Medical, LLC
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 January 2017

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