Designing a Placebo Microneedle Stamp: Modeling and Validation in a Clinical Control Trial

    March 2024 in “ Pharmaceutics
    Seung-Yeon Jeong, Ye‐Seul Lee, Ji-Yeun Park, Jung‐Hwan Park, Hi‐Joon Park, Song‐Yi Kim
    TLDR The placebo microneedle stamp didn't penetrate skin and caused less pain, but blinding was only effective for those with low skin sensitivity.
    The study aimed to design and validate a placebo microneedle (MN) stamp for clinical trials, involving 15 participants. The placebo stamp, featuring non-penetrating needles, was tested to ensure it did not penetrate the skin and to evaluate its effectiveness as a control. Results showed that the placebo stamp did not cause skin penetration and induced lower pain levels compared to the MN stamp. However, successful blinding was only achieved in participants with low skin sensitivity, highlighting challenges in achieving complete blinding. The study suggests further research is needed to develop effective placebo controls for MN studies, considering variations in needle length and count.
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