Efficacy and safety of a new microneedle patch for skin brightening: A Randomized, split-face, single-blind study.

BACKGROUND: Although microneedles are one of the best transdermal drug delivery systems for active compounds, few clinical trials have examined the safety and efficacy of brightening microneedle patches.

AIMS: To determine the efficacy and safety of a newly developed whitening microneedle patch.

PATIENTS/METHODS: A split-face study was designed for efficacy assessment with 34 Korean women applying the tested product (a whitening microneedle patch) on one cheek and a control whitening essence on the other. We objectively measured changes in melanin index values and skin brightness by mexameter and chromameter. Each participant also used global assessment to determine skin whitening. In addition, 55 participants were selected for primary skin irritation tests and repeated insult patch tests for safety assessments.

RESULTS: Mean skin brightness and melanin indexes improved (P<.05) 4 weeks and 8 weeks after product use in both the whitening patch and whitening essence groups. Significant differences (P<.05) were observed between the whitening patch and whitening essence groups 8 weeks after use. Global assessment by participants showed moderate cosmetic outcomes for both the whitening patch and whitening essence groups. No adverse effects were reported, and primary irritation and human repeated insult patch tests revealed no irritation from the test product.

CONCLUSIONS: A newly developed microneedle patch was effective and safe for skin brightening and would be a promising functional cosmetic product.