SkinPen Efficacy on Acne Scars on the Face and/or Back (NCT02646917) | Clinical Trial Compass
CompletedNot Applicable
SkinPen Efficacy on Acne Scars on the Face and/or Back
United States41 participantsStarted 2015-12
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 treat…
What they're measuring
1
Severity of Acne Scars
Timeframe: Baseline, 1 month post treatment, and 6 months post treatment
2
Clinician's Global Aesthetic Improvement Assessment (CGAIS)
Timeframe: 1 month post treatment, and 6 months post treatment