TY - JOUR
T1 - Safety of a novel microneedle device applied to facial skin
T2 - A subject- and rater-blinded, sham-controlled, randomized trial
AU - Hoesly, Fridolin J.
AU - Borovicka, Judy
AU - Gordon, Jennifer
AU - Nardone, Beatrice
AU - Holbrook, Jaimee S.
AU - Pace, Natalie
AU - Ibrahim, Omer
AU - Bolotin, Diana
AU - Warycha, Melanie
AU - Kwasny, Mary
AU - West, Dennis
AU - Alam, Murad
PY - 2012/6
Y1 - 2012/6
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84862675010&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84862675010&partnerID=8YFLogxK
U2 - 10.1001/archdermatol.2012.280
DO - 10.1001/archdermatol.2012.280
M3 - Article
C2 - 22431712
AN - SCOPUS:84862675010
SN - 0003-987X
VL - 148
SP - 711
EP - 717
JO - Archives of Dermatology
JF - Archives of Dermatology
IS - 6
ER -