N/A
N=10
Aldena STAR Particles
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT06004973 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Transepidermal Water Loss (TEWL) — 25.96; 20.44; 20.31; 23.82 g/m^2/hr
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- STAR Particles (Device); Gel without STAR Particles (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Transepidermal Water Loss (TEWL) |
25.96; 20.44; 20.31; 23.82; 19.33; 21.44 | — |
| SECONDARY Sensation After Application of STAR Particles (Part 2 Only) |
0.60; 0.60; 0.20; 0.10 | — |
| SECONDARY Evaluate Pain Using the Visual Analog Pain Scale (VAPS) After Application of the STAR Particles (Part 2 Only) |
1.90; 2.70; 0.80; 0.10 | — |
| SECONDARY Number or Participants Who Reported Standard Adverse Event (AE) |
0; 0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT06004973). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.