Atrophic Acne ScarNCT02646917
SkinPen Efficacy on Acne Scars on the Face and/or Back
A study testing Aesthetic Microneedling Treatment in people with Atrophic Acne Scar, run by Bellus Medical, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrophic Acne Scar
- What is being tested?
- Aesthetic Microneedling Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to 25 Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Atrophic Acne Scar
- Being tested
- Aesthetic Microneedling Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aesthetic Microneedling TreatmentProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| SkinPen II | Active comparator | Three treatments using SkinPen II aesthetic microneedling device to each patient, with each treatment spaced one month apart. Receives: Procedure: Aesthetic Microneedling Treatment |
| SkinPen Precision | Active comparator | Three treatments using SkinPen Precision aesthetic microneedling device to each patient, with each treatment spaced one month apart. Receives: Procedure: Aesthetic Microneedling Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Acne Scars
Goodman and Baron's Qualitative grading system. Possible scores range from 1 = mild to 4 = severe.
Measured: 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
Measured: 1 month post treatment, and 6 months post treatment
Secondary outcomes (3)
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)
Measured: 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 Scars
- 1-Exacerbation of acne scars 0 No change in the appearance of acne scars
- 1% - 25% improvement in the appearance of acne scars
- 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
Measured: 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
Measured: 1-Month Post Treatment and 6- Month Post Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2016
- Study completion25 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrophic Acne ScarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bellus Medical, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas J Stephens, Ph.D, Principal investigator, Thomas J. Stephens & Associates, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02646917
- Sponsor's protocol ID
- Bellmed001
- Status last verified
- Jun 2021
- First submitted
- 21 Dec 2015
- Last updated
- 21 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02646917
- Acronym / sponsor ID
- Bellmed001
- Conditions
- Atrophic Acne Scar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Bellus Medical, LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- 25 Jul 2017 (actual)
- First posted
- 6 Jan 2016 (estimated)
- Results
- Posted 21 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SkinPen II | Active comparator | Procedure: Aesthetic Microneedling TreatmentThree treatments using SkinPen II aesthetic microneedling device to each patient, with each treatment spaced one month apart. |
| SkinPen Precision | Active comparator | Procedure: Aesthetic Microneedling TreatmentThree treatments using SkinPen Precision aesthetic microneedling device to each patient, with each treatment spaced one month apart. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (19 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aesthetic Microneedling TreatmentTreatment 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. | Procedure or surgery | SkinPen II, SkinPen Precision |
Primary outcome
Severity of Acne Scars
Time frame: 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)
Time frame: 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
3 secondary outcomes
Photo Grading of Acne Scar Assessment
Time frame: Day 1 (Baseline), Day 30, Day 60, 1-Month post treatment and 6 Month post treatment
Subject Self-Assessment Using SASIS
Time frame: One Month Post Treatment, 6 Month Post Treatment
Subject Self-Assessment Using Global Aesthetic Improvement Scale (SGAIS)
Time frame: 1-Month Post Treatment and 6- Month Post Treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas J Stephens, Ph.D principal investigator
Thomas J. Stephens & Associates, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aesthetic Microneedling Treatment in people with Atrophic Acne Scar, run by Bellus Medical, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of Acne Scars (time frame: Baseline, 1 month post treatment, and 6 months post treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2021.