Efficacy and Human Safety of Microneedle Patches Containing Cannabidiol (YC-2106) from Cannabis sativa in Treating Inflammatory Diseases

Purpose: In this study, a microneedle patch (MNP) containing cannabidiol (CBD, YC-2106) was produced, and its efficacy was evaluated for human safety and the treatment of inflammatory diseases. Methods: First, MNPs containing 0%, 1%, and 3% cannabidiol were prepared. To evaluate the anti-inflammatory efficacy, a human skin tissue model (KeraSkin™) was purchased, the culture medium was collected 24 h and 48 h after MNP attachment, and the expression of interleukin-8 (IL-8) was compared and analyzed. A primary dermal irritation test was performed by requesting SGS certification in the United States, where an MNP was attached to 32 participants, and the attachment site was checked after 48 h and 96 h to confirm the occurrence of side effects. Results: No significant decrease in IL-8 expression was observed 24 h after lipopolysaccharide (LPS)-induced inflammation. However, after 48 h, IL-8 expression was significantly inhibited in the group treated with MNPs containing 1% and 3% CBD. In the primary dermal irritation test, no side effects were observed in any of the participants; therefore, safety was confirmed in the percutaneous phase. Conclusion: The CBD-MNP is effective in treating inflammatory diseases through the inhibition of IL-8 expression and exhibits high potential as a percutaneous drug for inflammatory treatment, which is safe for use in the human body.