Atrophic Acne Scar
Conditions
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.
Interventions
PROCEDUREAesthetic 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.
Sponsors
Bellus Medical, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Acne Scars | 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. |
| Clinician's Global Aesthetic Improvement Assessment (CGAIS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Photo Grading of Acne Scar Assessment | 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) |
| Subject Self-Assessment Using SASIS | 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 |
| Subject Self-Assessment Using Global Aesthetic Improvement Scale (SGAIS) | 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 |
Countries
United States
Participant flow
Recruitment details
Pre-screening was conducted by phone to determine eligibility criteria through and IRB-approved script. Followed by in-clinic screening visits conducted between December 7, 2015 and February 19, 2016.
Pre-assignment details
Only participants who met eligibility requirements were enrolled into the study and assigned to groups.
Participants by arm
| Arm | Count |
|---|---|
| SkinPen II 3 treatments with SkinPen II to each patient, each one month apart.
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. | 21 |
| SkinPen Precision 3 treatments with SkinPen Precision to each patient, each one month apart.
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. | 20 |
| Total | 41 |
Baseline characteristics
| Characteristic | SkinPen II | SkinPen Precision | Total |
|---|---|---|---|
| Age, Customized Completed Subjects | 44.2 years STANDARD_DEVIATION 11.4 | 43.8 years STANDARD_DEVIATION 12.7 | 44 years STANDARD_DEVIATION 11.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 6 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 14 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 3 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 6 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 10 Participants | 20 Participants |
| Region of Enrollment United States | 21 participants | 20 participants | 41 participants |
| Sex: Female, Male Female | 15 Participants | 13 Participants | 28 Participants |
| Sex: Female, Male Male | 6 Participants | 7 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 1 / 20 |
| other Total, other adverse events | 1 / 21 | 2 / 20 |
| serious Total, serious adverse events | 0 / 21 | 0 / 20 |
Outcome results
Primary
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
Population: The analysis population includes all participants who completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Skinpen ll | Clinician's Global Aesthetic Improvement Assessment (CGAIS) | 1-Month Post Treatment | 3.10 score on a scale | Standard Deviation 0.77 |
| Skinpen ll | Clinician's Global Aesthetic Improvement Assessment (CGAIS) | 6-Months Post-Treatment | 2.76 score on a scale | Standard Deviation 0.77 |
| Skinpen Precision | Clinician's Global Aesthetic Improvement Assessment (CGAIS) | 1-Month Post Treatment | 3.20 score on a scale | Standard Deviation 0.77 |
| Skinpen Precision | Clinician's Global Aesthetic Improvement Assessment (CGAIS) | 6-Months Post-Treatment | 2.70 score on a scale | Standard Deviation 0.86 |
Comparison: Null hypothesis 4 (no change).p-value: <0.001Wilcoxen signed-rank test
Primary
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
Population: The analysis population includes all participants who completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Skinpen ll | Severity of Acne Scars | Baseline | 3.19 score on a scale | Standard Deviation 0.4 |
| Skinpen ll | Severity of Acne Scars | 1-Month Post Treatment | 2.81 score on a scale | Standard Deviation 0.68 |
| Skinpen ll | Severity of Acne Scars | 6-Months Post-Treatment | 2.62 score on a scale | Standard Deviation 0.59 |
| Skinpen Precision | Severity of Acne Scars | Baseline | 3.10 score on a scale | Standard Deviation 0.31 |
| Skinpen Precision | Severity of Acne Scars | 1-Month Post Treatment | 2.90 score on a scale | Standard Deviation 0.55 |
| Skinpen Precision | Severity of Acne Scars | 6-Months Post-Treatment | 2.70 score on a scale | Standard Deviation 0.57 |
Comparison: Goodman and Baron's qualitative acne scar severity scores. Calculated from Wilcoxon signed-rank test. Testing hypothesis is that the mean change from baseline is equal to zero.p-value: <0.008Wilcoxon (Mann-Whitney)
Secondary
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
Population: The analyxed population includes all participants who completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Skinpen ll | Photo Grading of Acne Scar Assessment | Day 30 | 2.55 Score on a Scale | Standard Deviation 0.59 |
| Skinpen ll | Photo Grading of Acne Scar Assessment | 1-Month post treatment | 2.71 Score on a Scale | Standard Deviation 0.75 |
| Skinpen ll | Photo Grading of Acne Scar Assessment | Baseline | 2.81 Score on a Scale | Standard Deviation 0.58 |
| Skinpen ll | Photo Grading of Acne Scar Assessment | 6-Month post treatment | 2.81 Score on a Scale | Standard Deviation 0.68 |
| Skinpen ll | Photo Grading of Acne Scar Assessment | Day 60 | 2.67 Score on a Scale | Standard Deviation 0.53 |
| Skinpen Precision | Photo Grading of Acne Scar Assessment | 6-Month post treatment | 2.35 Score on a Scale | Standard Deviation 0.59 |
| Skinpen Precision | Photo Grading of Acne Scar Assessment | Baseline | 2.80 Score on a Scale | Standard Deviation 0.52 |
| Skinpen Precision | Photo Grading of Acne Scar Assessment | Day 30 | 2.78 Score on a Scale | Standard Deviation 0.57 |
| Skinpen Precision | Photo Grading of Acne Scar Assessment | Day 60 | 2.70 Score on a Scale | Standard Deviation 0.55 |
| Skinpen Precision | Photo Grading of Acne Scar Assessment | 1-Month post treatment | 2.68 Score on a Scale | Standard Deviation 0.49 |
Comparison: Calculated from Wilcoxon signed-rank test. The testing hypothesis is that the mean change from baseline is equal to zerop-value: <0.01Wilcoxon (Mann-Whitney)
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Skinpen ll | Subject Self-Assessment Using Global Aesthetic Improvement Scale (SGAIS) | 1-Month Post Treatment | 2.71 Score on a Scale | Standard Deviation 1.06 |
| Skinpen ll | Subject Self-Assessment Using Global Aesthetic Improvement Scale (SGAIS) | 6- Month Post Treatment | 0.91 Score on a Scale | Standard Deviation 1 |
| Skinpen Precision | Subject Self-Assessment Using Global Aesthetic Improvement Scale (SGAIS) | 1-Month Post Treatment | 2.85 Score on a Scale | Standard Deviation 0.75 |
| Skinpen Precision | Subject Self-Assessment Using Global Aesthetic Improvement Scale (SGAIS) | 6- Month Post Treatment | 2.50 Score on a Scale | Standard Deviation 0.83 |
p-value: <0.01Wilcoxon (Mann-Whitney)
Secondary
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
Time frame: One Month Post Treatment, 6 Month Post Treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Skinpen ll | Subject Self-Assessment Using SASIS | 1-Month Post treatment | 1.67 Score on a Scale | Standard Deviation 1.49 |
| Skinpen ll | Subject Self-Assessment Using SASIS | 6-Month Post treatment | 1.71 Score on a Scale | Standard Deviation 1.23 |
| Skinpen Precision | Subject Self-Assessment Using SASIS | 1-Month Post treatment | 1.65 Score on a Scale | Standard Deviation 0.93 |
| Skinpen Precision | Subject Self-Assessment Using SASIS | 6-Month Post treatment | 1.70 Score on a Scale | Standard Deviation 1.08 |
Comparison: Calculated from Wilcoxon signed-rank test. The testing hypothesis is that the mean score is equal to 0 (no change in the appearance of acne scars).p-value: <0.01Wilcoxon (Mann-Whitney)