Aldena STAR Particles

Healthy Clinical Trial

Official title: Usability of STAR Particles in Healthy Volunteers: A Pilot Study

Status Recruiting

Clinical Trial 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 for the collection of medical information and assessing eligibility in the study. The second visit will have the application of STAR particles on different areas of the arm and hand with different pressures to see 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.

Clinical Trial Description

The goal of this study is to identify the most efficacious pressure of administration and the minimum number of rubbing cycles necessary to perforate the stratum corneum (the outermost layer of the skin).

Many medical indications are treated through the topical application of a therapeutic compound formulated into a gel, cream, ointment, or lotion (e.g., eczema, psoriasis, actinic keratosis, cutaneous warts, etc.). This is especially true in dermatology in which the skin is often the primary site of action. Topicals (i.e., drugs applied to the skin's surface) allow patients to easily self-apply these therapies without the need for painful or difficult-to-use medical technologies (e.g., hypodermic needles) or the risks associated with systemic exposure to a drug (e.g., oral, intravenous, or intramuscular administration).

Despite the advantages associated with topical delivery, the skin serves as a barrier in the transport of most external compounds. There are several techniques to overcome the skin barrier. There have been several studies to increase skin permeability such as chemical, biochemical, and physical methods. However, chemical and biochemical methods do not appear to be broadly useful for the delivery of large molecule therapeutics (e.g., peptides, proteins, genetic material) across the skin. STAR particles are millimeter-scale particles with micron-scale projections made of biocompatible materials that painlessly disrupt the stratum corneum. As STAR particles are rubbed on the skin, their microscopic projections create micron-scale pores in the stratum corneum to increase skin permeability to topical compounds independent of physicochemical properties. After the arms of the STAR particle puncture the skin, the elastic forces of the skin push the particles out. The first 10 participants will receive the 8 interventions (different application pressures) plus the control (Site and treatment will not be randomly assigned on the arm) by the investigator. In addition, two applications of STAR particles will be applied to one of the hands. After these participants have completed the study, an interim analysis will be performed. At this point, a decision will be made by the investigator to determine if changes in STAR particle administration will be implemented for the next 10 participants. ;

Related Conditions & MeSH terms

• Healthy

• NCT number: NCT06004973
• Study type: Interventional
• Source: Emory University
• Contact: Eric I Felner, MD, MSCR
• Phone: 404-727-7651
• Email: efelner@emory.edu
• Status: Recruiting
• Phase: N/A
• Start date: February 7, 2024
• Completion date: August 2024