title: Safety of a novel microneedle device applied to facial skin: a subject- and rater-blinded, sham-controlled, randomized trial.
abstract: OBJECTIVE
  To assess the safety of a novel microneedle device on facial skin of healthy individuals of all Fitzpatrick skin types.
  
  
  METHODS
  Subject- and live rater–blinded, sham-controlled, randomized trial.
  
  
  METHODS
  University-based ambulatory dermatology service providing both primary and referral care.
  
  
  METHODS
  Healthy adults recruited from postings.
  
  
  METHODS
  Device or sham applied with finger pressure to the right or left sides, respectively, of the participants' lateral forehead, temple, and nasolabial fold. At the 24-hour visit, a larger area (3 × 3 matrix) at the central forehead was treated with the device, and the participants applied the device to their chins.
  
  
  METHODS
  Live blinded rater determination of local skin reaction scores (SRSs).
  
  
  RESULTS
  At the 5-minute skin assessment, the median SRS was 1 for all skin type and age groups. There was no median pain score higher than 1 for any age or skin type group. For the sham device, median SRSs were 0 at all time points for all age and skin type groups. Mean SRSs for the device and sham were significantly different only for the lateral forehead at 5 and 30 minutes (P = .04).
  
  
  CONCLUSIONS
  The microneedle device appears to be safe and well tolerated in both sexes and various skin types and ages. Facial skin application of the device elicits mild, self-limited, and rapidly resolving erythema marginally greater than that associated with the sham control.
authors.affiliation: Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.
authors.forename: Fridolin J
authors.initials: FJ
authors.lastname: Hoesly
authors.forename: Judy
authors.initials: J
authors.lastname: Borovicka
authors.forename: Jennifer
authors.initials: J
authors.lastname: Gordon
authors.forename: Beatrice
authors.initials: B
authors.lastname: Nardone
authors.forename: Jaimee S
authors.initials: JS
authors.lastname: Holbrook
authors.forename: Natalie
authors.initials: N
authors.lastname: Pace
authors.forename: Omer
authors.initials: O
authors.lastname: Ibrahim
authors.forename: Diana
authors.initials: D
authors.lastname: Bolotin
authors.forename: Melanie
authors.initials: M
authors.lastname: Warycha
authors.forename: Mary
authors.initials: M
authors.lastname: Kwasny
authors.forename: Dennis
authors.initials: D
authors.lastname: West
authors.forename: Murad
authors.initials: M
authors.lastname: Alam
mesh_terms: D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000368:Aged; D000554:Ambulatory Care Facilities; D004311:Double-Blind Method; D016503:Drug Delivery Systems / Q000009:adverse effects* / Q000295:instrumentation; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008845:Microinjections / Q000009:adverse effects*; D008875:Middle Aged; D009339:Needles; D004364:Pharmaceutical Preparations / Q000008:administration & dosage; D012867:Skin / Q000378:metabolism*; D013678:Technology, Pharmaceutical / Q000295:instrumentation; D013997:Time Factors; D055815:Young Adult
chemical_list: D004364:Pharmaceutical Preparations