Aldena STAR Particles

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Device: STAR Particles


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STAR Particles<br>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. | Device: STAR Particles<br>* 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) and 100 mg of aloe vera will be applied to the control site on one of the forearms. Two rubbing cycles (20 and 30 cycles at 1 cycle/second) and three pressures (40, 60, and 80 kPa) will be evaluated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in conditions for the administration of STAR particles to penetrate the stratum corneum | Identification of the most efficacious conditions for the administration of STAR particles will be measured by the number of perforations per cm2 using Gentian Violet (GV) staining and trans-epidermal water loss (TEWL) measurement before and after application of STAR particles [(T0 (before), T20 (after), T30, GV)]. | Before application, 20 minutes after application, and 30 minutes after application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the sensation and pain during and after application of STAR particle | Participants will complete a tolerability questionnaire with questions regarding a list of specific symptoms. Did you experience any of the following (yes/no)? If yes, how strong (very slight, slight, moderate, strong, very strong) was the sensation in the different area or sites? Was the sensation comfortable, bothersome (yes/no)? | Immediately After STAR particles application | 
| Assess standard adverse event (AE) | Removal & Disposal Questionnaire | Enrollment until 5 days after the last visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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STAR particles, Skin