Aldena STAR Particles

Usability of STAR Particles in Healthy Volunteers: A Pilot Study

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: STAR Particles; Device: Gel without STAR Particles

Detailed 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 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory Children's Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STAR Particles application; 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; 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
Other: Control Application; Participants 1 to 10 will receive one control application on the volar side of one forearm. Participants 11 to 20 will receive one control application on the opposite forearm and on the contralateral side of the face.	Device: Gel without STAR Particles; 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).; Other Names: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transepidermal Water Loss (TEWL)	Trans-epidermal water loss (TEWL) measurement (only for the first 10 participants 1-10) before and after application of STAR particles [(T0 (before), T20 (after), T30 (after)].	Before application, 20 minutes after application, and 30 minutes after application

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensation After Application of STAR Particles (Part 2 Only)	Measured using a Likert-type scale ranging from 0 to 5, where 0 = No Pain and 5 = Severe Pain. Higher scores indicate greater perceived sensation. Sensation was evaluated only among participants in the STAR Particles study, Part 2.	Immediately After STAR particles application
Evaluate Pain Using the Visual Analog Pain Scale (VAPS) After Application of the STAR Particles (Part 2 Only)	The Visual Analog Pain Scale is a tool used to measure a person's pain intensity. It is a unidimensional scale, typically represented by a straight line often depicted as a 100 mm line with one end marked "no pain" (0) and the other marked "worst imaginable pain" (100). For this outcome, results will be reported as a percentage of the 100 mm VAPS scale, where 0% corresponds to no pain and 100% corresponds to the worst imaginable pain. A higher percentage indicates greater pain intensity. VAPS was evaluated only among participants in the STAR Particles study, Part 2.	Immediately After STAR particles application
Number or Participants Who Reported Standard Adverse Event (AE)	Number of participants during each period of participation who reported any adverse events after the removal of the STAR particles at any of the sites of application.	Up to 5 days after the STAR particles removal (for a total of 5 days)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Experience Adverse Events Due to Residual STAR Particles	Participants will perform a visual inspection of the residual STAR particles after their removal and report any adverse events due to residual STAR particles up to 30 days after removal.	After STAR particles removal up to 30 days (for a total of 30 days)

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Eric I Felner, MD, MSCR, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2024
• Primary Completion (Actual): November 7, 2024
• Study Completion (Actual): December 7, 2024

Study Registration Dates

• First Submitted: June 18, 2023
• First Submitted That Met QC Criteria: August 16, 2023
• First Posted (Actual): August 22, 2023

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: January 19, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Skin; STAR particles
• Other Study ID Numbers: STUDY00005486; 2024P008520 (Other Identifier: Emory IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes