In the clinical efficacy test of four skin-improvement parameters, adenosine-loaded dissolving microneedle patches showed the same or better effect than the adenosine cream, although the weekly adenosine dose was 140 times lower. The dissolving microneedle patches caused no adverse reactions. These adenosine-loaded dissolving microneedle patches are expected to be safe, effective, and novel cosmetics for skin improvement.
Objectives
Dissolving microneedle patches have been extensively studied in the field of cosmetics comparison with topical cosmetics focusing on the delivery of active ingredients. Nevertheless, the skin improvement effect of hyaluronic acid, which is mainly used as a backbone material for dissolving microneedle, was not analyzed. In this study, adenosine encapsulated high and low molecular weight hyaluronic acid dissolving microneedle patch (Ad‐HMN and Ad‐LMN) were evaluated with respect to skin wrinkling, dermal density, elasticity, and safety in a clinical test on the crow’s feet area.
Methods
Clinical efficacy and safety tests were performed for 12 weeks on twenty three female subjects with wrinkles around their eyes. The Ad‐HMN and Ad‐LMN patch were applied once every 3 days, in the evening, for 8 weeks to the designated crow’s feet area. Skin wrinkling, dermal density, and elasticity were measured by using PRIMOS® premium, Dermascan®C, Cutometer® MPA580, and Corneometer® CM 825, respectively.
Results
Both Ad‐HMN and Ad‐LMN groups showed statistically significant efficacy for almost all parameters. The Ad‐HMN patch had better effect on the mean depth of biggest wrinkles, maximum depth of biggest wrinkles, dermal density, and skin elasticity than the Ad‐LMN patch. No adverse effects were observed in either group during the test period.
Conclusion
In the clinical efficacy test of four skin‐improvement parameters, the Ad‐HMN patch showed the better effect than the Ad‐LMN patch with the similar adenosine dose.
Summary
Background
Dissolving microneedles (DMNs), microscale needles with a biodegradable polymer matrix, have been widely investigated for transdermal drug delivery. However, the restricted drug loading space of DMNs limited the delivery of the desired quantity of active compounds. In this study, we developed novel combinatorial therapies involving sequential application of adenosine‐loaded DMN (Ad‐DMN) patches and a topical adenosine‐loaded cream (Ad‐cream). The application of DMNs created skin channels, which delivered encapsulated drugs from both the DMNs and cream. The use of combinatorial therapies can maximize drug delivery.
Methods
To compare the efficacy of combinatorial therapies and Ad‐cream application, a double‐blind clinical test was conducted over 10 weeks on 21 females with wrinkles around their eyes, and the skin parameters such as wrinkles, dermal density, elasticity, and hydration were analyzed. The skin irritation test was assessed by expert interviewers to elucidate undesirable side effects.
Results
The combinatorial therapies showed statistically significant efficacy for the improvement of average depth of wrinkles, dermal density, elasticity, and hydration after an 8‐week application (P < 0.001). Adverse effects on the skin were not observed in any subject during the test period.
Conclusion
The efficacy and safety results showed that the combinatorial therapies were a safe and outstanding innovation for the optimization of transdermal therapy.
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