At a glance
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Usability of STAR Particles in Healthy Volunteers: A Pilot Study
In Brief
A clinical study evaluating STAR Particles and Gel without STAR Particles for Healthy. Completed, enrolled 20 participants across 1 site.
Detailed Summary
The objective of this study is to find out the best method of applying STAR particles to the skin. STAR particles are very small particles with microneedles on the surface that can increase and create small punctures in the skin. The small punctures should allow for different topical medications to work more effectively. This is important to understand the potential use of STAR particles in future topical medications. This study will not use any medication with active ingredients. The study will include healthy adult participants. The first visit will be to collect medical information and assess eligibility in the study. The second visit will have the application of STAR particles on different areas of the arm, hand, and face with different pressures to determine what the most effective method of application is. The skin will be evaluated after the application, and surveys will be collected on the tolerability of the application.
Study Details
Timeline
Interventions
A 1.5-gram dose of STAR particles (10% concentration in aloe vera ointment) will be applied to the eight application sites (forearm and hand). Two rubbing cycles (30 and 60 cycles at a minimum of 1 cycle/second) and three pressures (40, 60, and 80 kPa) will be evaluated
A 100mg dose of the gel without STAR particles is applied to the control site (the forearm for all participants and, additionally, the face for participants 11-20).