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.
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
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.
Stephens & Associates
Richardson, Texas, United States
Severity of Acne Scars
Goodman and Baron's Qualitative grading system. Possible scores range from 1 = mild to 4 = severe.
Time frame: 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
Time frame: 1 month post treatment, and 6 months post treatment
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. 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)
Time frame: 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): 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
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Time frame: 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 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
Time frame: 1-Month Post Treatment and 6- Month Post Treatment