Aldena STAR Particles

NCT06004973 | Completed Results FDA Device

• 2 other identifiers: STUDY000054862024P008520
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

STAR particles; Skin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Sensation After Application of STAR Particles (Part 2 Only)

  Immediately After STAR particles application

• Evaluate Pain Using the Visual Analog Pain Scale (VAPS) After Application of the STAR Particles (Part 2 Only)

  Immediately After STAR particles application

• Number or Participants Who Reported Standard Adverse Event (AE)

  Up to 5 days after the STAR particles removal (for a total of 5 days)

Other Outcomes (1)

• Number of Participants Who Experience Adverse Events Due to Residual STAR Particles

  After STAR particles removal up to 30 days (for a total of 30 days)

Study Arms (2)

STAR Particles application

EXPERIMENTAL

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

Control Application

OTHER

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

Interventions

STAR Particles DEVICE

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

STAR Particles application

Gel without STAR Particles DEVICE

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).

Also known as: Control

Control Application

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory Children's Center

Atlanta, Georgia, 30322, United States

Location

Results Point of Contact

• Title: Eric I Felner, MD, MSCR, Professor of Pediatrics
• Organization: Emory University

efelner@emory.edu

404-785-0935

Study Officials

• Eric I Felner, MD, MSCR

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: June 18, 2023
• First Posted: August 22, 2023
• Study Start: February 7, 2024
• Primary Completion: November 7, 2024
• Study Completion: December 7, 2024
• Last Updated: February 4, 2026
• Results First Posted: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)