The Current Status of Clinical Research Involving Microneedles: A Systematic Review

Abstract

In recent years, a number of clinical trials have been published on the efficacy and safety of drug delivery using microneedles (MNs). This review aims to systematically summarize and analyze the current evidence including the clinical effect and safety of MNs. Three electronic databases, including PubMed, were used to search the literature for randomized controlled trials (RCTs) and clinical controlled trials (CCTs) that evaluated the therapeutic efficacy of MNs from their inception to 28 June 2018. Data were extracted according to the characteristics of study subjects; disorder, types, and details of the intervention (MNs) and control groups; outcome measurements; effectiveness; and incidence of adverse events (AEs). Overall, 31 RCTs and seven CCTs met the inclusion criteria. Although MNs were commonly used in skin-related studies, evaluating the effects of MNs was difficult because many studies did not provide adequate comparison values between groups. For osteoporosis treatment, vaccine, and insulin delivery studies, MNs were comparable to or more effective than the gold standard. Regarding the safety of MNs, most AEs reported in each study were minor (grade 1 or 2). A well-designed RCT is necessary to clearly evaluate the effectiveness of MNs in the future.

Keywords: microneedle; randomized controlled trial; research and development; systematic review.

Figure 1

Flow chart for selection of studies.

Figure 2

Number of studies included by diseases or microneedles types.

Figure 3

Risk of bias graph: (A) Risk of bias graph of randomized controlled trials (RCTs); (B) Risk of bias graph of controlled clinical trials (CCTs).3.3.2. Risk of Bias in Clinical Controlled Trials (Non Randomized Studies) (n = 7).