HealthyNCT06004973
Aldena STAR Particles
A study testing STAR Particles and Gel without STAR Particles in people with Healthy, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- STAR Particles and Gel without STAR Particles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2024to 7 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- STAR Particles, Gel without STAR Particles
- Keywords
- STAR particles, Skin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAR ParticlesDevice
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
Gel without STAR ParticlesDevice
Also called Control
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Gel without STAR Particles |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)].
Measured: Before application, 20 minutes after application, and 30 minutes after application
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Up to 5 days after the STAR particles removal (for a total of 5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start7 Feb 2024
- Primary completion7 Nov 2024
- Study completion7 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Felner, Emory University
- Investigators
- Eric I Felner, MD, MSCR, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004973
- Sponsor's protocol ID
- STUDY00005486
- Other IDs
- 2024P008520
- Status last verified
- Jan 2026
- First submitted
- 18 Jun 2023
- Last updated
- 4 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability of STAR Particles in Healthy Volunteers: A Pilot Study
- ClinicalTrials.gov ID
- NCT06004973
- Acronym / sponsor ID
- STUDY00005486
- Conditions
- Healthy
- Keywords
- STAR particles, Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- 7 Nov 2024 (actual)
- Study completion
- 7 Dec 2024 (actual)
- First posted
- 22 Aug 2023 (actual)
- Results
- Posted 4 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STAR Particles application | Experimental | Device: STAR ParticlesParticipants 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. |
| Control Application | Other | Device: Gel without STAR ParticlesParticipants 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. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STAR ParticlesA 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 | Device | STAR Particles application |
| Gel without STAR ParticlesAlso: ControlA 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). | Device | Control Application |
Primary outcome
Transepidermal Water Loss (TEWL)
Time frame: Before application, 20 minutes after application, and 30 minutes after application
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)].
3 secondary outcomes
Sensation After Application of STAR Particles (Part 2 Only)
Time frame: Immediately After STAR particles application
Evaluate Pain Using the Visual Analog Pain Scale (VAPS) After Application of the STAR Particles (Part 2 Only)
Time frame: Immediately After STAR particles application
Number or Participants Who Reported Standard Adverse Event (AE)
Time frame: Up to 5 days after the STAR particles removal (for a total of 5 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric I Felner, MD, MSCR principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STAR Particles and Gel without STAR Particles in people with Healthy, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transepidermal Water Loss (TEWL) (time frame: Before application, 20 minutes after application, and 30 minutes after application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.