Objective To assess the safety of a novel microneedle device on facial skin of healthy individuals of all Fitzpatrick skin types. Design Subject- and live rater–blinded, sham-controlled, randomized trial. Setting University-based ambulatory dermatology service providing both primary and referral care. Participants Healthy adults recruited from postings. Intervention 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. Main Outcome Measure 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. Trial Registration clinicaltrials.gov Identifier: NCT01257763
