Safety of a novel microneedle device applied to facial skin: a subject- and rater-blinded, sham-controlled, randomized trial.

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.