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, shamcontrolled, 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 x 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.
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