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

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

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.

Study Overview

• Status: Completed
• Conditions: Atrophic Acne Scar
• Intervention / Treatment: Procedure: Aesthetic Microneedling Treatment

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
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Richardson, Texas, United States, 45081
      • Stephens & Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of Acne Scars	Goodman and Baron's Qualitative grading system. Possible scores range from 1 = mild to 4 = severe.	Baseline, 1 month post treatment, and 6 months post treatment
Clinician's Global Aesthetic Improvement Assessment (CGAIS)	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	1 month post treatment, and 6 months post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Photo Grading of Acne Scar Assessment	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.; - 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).; - 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)	Day 1 (Baseline), Day 30, Day 60, 1-Month post treatment and 6 Month post treatment
Subject Self-Assessment Using SASIS	Subject self-assessment was completed in 2 steps for self-assessed scar improvement scale (SASIS) and subject global aesthetic improvement scale (SGAIS): Based on a live assessment (subjects were provided with a hand mirror for assessment) of the subject while referring to pre-treatment images.; Based on a comparison of pre-treatment images to current post-treatment images. Rating of Acne Scars1-Exacerbation of acne scars 0 No change in the appearance of acne scars1% - 25% improvement in the appearance of acne scars25% - 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	One Month Post Treatment, 6 Month Post Treatment
Subject Self-Assessment Using Global Aesthetic Improvement Scale (SGAIS)	The following rating scale was used for SGAIS: Rating and Description; - Very much improved: Optimal cosmetic result; - Much improved: Marked improvement in appearance from the initial condition, but not completely optimal; - Improved: Obvious improvement in appearance from initial condition; -No change: The appearance is essentially the same as the original condition; - Worse: The appearance is worse than the original condition	1-Month Post Treatment and 6- Month Post Treatment

Collaborators and Investigators

• Sponsor: Bellus Medical, LLC
• Investigators: Principal Investigator: Thomas J Stephens, Ph.D, Thomas J. Stephens & Associates, Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): July 25, 2017

Study Registration Dates

• First Submitted: December 21, 2015
• First Submitted That Met QC Criteria: January 4, 2016
• First Posted (Estimate): January 6, 2016

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: June 30, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Atrophy
• Other Study ID Numbers: Bellmed001