SkinPen Efficacy on Acne Scars on the Face and/or Back

Bellus Medical

Status

Completed

Conditions

Atrophic Acne Scar

Treatments

Procedure: Aesthetic Microneedling Treatment

Study type

Interventional

Funder types

Industry

Identifiers

NCT02646917

Bellmed001

Details and patient eligibility

About

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.

Full 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.

Enrollment

41 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.