Aldena STAR Particles

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 conditions 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). 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 to the transport of most external compounds. There are several techniques to overcome the skin barrier. Several studies have been conducted to increase skin permeability using various methods, including chemical, biochemical, and physical approaches. 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 to 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.

Inclusion criteria

• Adult, 18 - 39 years of age
• In good general health as determined by a medical history
• Willing and able to provide informed consent and follow all study requirements
• Not pregnant and does not desire to become pregnant in the subsequent two months

Exclusion criteria

• Has a known allergy or sensitivity to aloe vera or alumina
• Has any skin disorders or skin allergies
• Has any medical condition that may affect skin or skin sensation
• Has abnormal (e.g., tattooed) skin at forearms
• Has known neurological condition affecting sensory function or perception of pain
• Has inflammatory bowel disease
• Has applied skin ointment or cream to forearms in the previous 24 hours
• Has a major congenital or chromosomal abnormality known to affect the skin
• Has taken pain medication in the last 24 hours
• Is currently participating in another interventional clinical trial
• Has previously participated in a STAR particle interventional clinical trial
• Is pregnant or wishing to be pregnant
• Has any condition (social or medical), which in the opinion of the investigator would make study participation unsafe, would interfere with adherence to the clinical study requirements, or would complicate data interpretation