Clinical trial NCT02646917: SkinPen Efficacy on Acne Scars on the Face and/or Back
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrophic Acne Scar
Lead sponsor: Bellus Medical, LLC
Sponsor class: INDUSTRY
First posted: 2016-01-06
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Severity of Acne Scars
timeFrame: Baseline, 1 month post treatment, and 6 months post treatment
measure: Clinician's Global Aesthetic Improvement Assessment (CGAIS)
timeFrame: 1 month post treatment, and 6 months post treatment
Secondary outcomes:
measure: Photo Grading of Acne Scar Assessment
timeFrame: Day 1 (Baseline), Day 30, Day 60, 1-Month post treatment and 6 Month post treatment
measure: Subject Self-Assessment Using SASIS
timeFrame: One Month Post Treatment, 6 Month Post Treatment
measure: Subject Self-Assessment Using Global Aesthetic Improvement Scale (SGAIS)
timeFrame: 1-Month Post Treatment and 6- Month Post Treatment
Other outcomes:
Locations:
city: Richardson
country: United States
facility: Stephens & Associates
state: Texas
Study officials:
affiliation: Thomas J. Stephens & Associates, Inc.
name: Thomas J Stephens, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: