A microneedle device designed to administer drugs to the stratum corneum was well-tolerated by users in a recent study.
In a subject- and rater-blinded, sham-controlled randomized trial, researchers tested the Microchannel Skin System, a microneedle device developed by 3M Company, on 54 healthy participants aged 18 to 74 years across all Fitzpatrick skin types.
During a baseline visit, investigators applied either the device or an identical sham device lacking microneedles with finger pressure to the lateral forehead, temple and nasolabial fold three times for 10 seconds each. Participants indicated pain levels on a 10-point scale at each application, and investigators performed skin assessments at 5 minutes, 30 minutes, 1 hour, 2 hours and 4 hours after application. After 24 hours, along with further skin assessments at six sites for each participant, the device also was applied nine times to the central forehead, and participants self-applied the device three times to the chin.
Across all applications, participants reported a median skin reaction score of 1 at the 5-minute assessment, compared with a median score of 0 for all applications of the sham device. No individuals reported a reaction score of more than 1 beyond the 1-hour assessment. The mean skin reaction scores between the device and the sham were only significantly different for the lateral forehead applications at the 5- and 30-minute assessments (P=.04).
No median pain scores of more than 1 were reported across all age and skin type groups using the device, but pain reported at the lateral forehead, temple and nasolabial fold was significant compared with that from the sham device (P<.001). Adverse events reported included mild stinging and irritation (17% of patients) and mild pruritus (7%).
“This device appears to offer a safe and practical mechanism by which to potentially enhance cutaneous absorption of topically applied medications,” researchers wrote. “Additional studies with concomitant use of substances such as topical anesthetics … may better delineate the clinical utility of this novel [microneedle device].”