N/A
N=41
SkinPen Efficacy on Acne Scars on the Face and/or Back
Atrophic Acne Scar
Bottom Line
View on ClinicalTrials.gov: NCT02646917 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Severity of Acne Scars — 3.19; 3.10; 2.81; 2.90 score on a scale — p=<0.008
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Aesthetic Microneedling Treatment (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bellus Medical, LLC
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Severity of Acne Scars |
3.19; 3.10; 2.81; 2.90; 2.62; 2.70 | <0.008 sig |
| PRIMARY Clinician's Global Aesthetic Improvement Assessment (CGAIS) |
3.10; 3.20; 2.76; 2.70 | <.001 sig |
| SECONDARY Photo Grading of Acne Scar Assessment |
2.81; 2.80; 2.55; 2.78; 2.67; 2.70 | <0.01 sig |
| SECONDARY Subject Self-Assessment Using SASIS |
1.67; 1.65; 1.71; 1.70 | <0.01 sig |
| SECONDARY Subject Self-Assessment Using Global Aesthetic Improvement Scale (SGAIS) |
2.71; 2.85; 0.91; 2.50 | <0.01 sig |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02646917). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.