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STAR Particles for Skin Treatment Enhancement

N/A
Recruiting
Led By Eric I Felner, MD, MSCR
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after star particles removal up to 30 days
Awards & highlights

Study Summary

This trial will test the best way to use small particles with needles on the surface to puncture the skin, to help topical medications work better.

Who is the study for?
This trial is for healthy adults aged 18-39 who can consent to study requirements. Participants must not be pregnant or planning pregnancy soon, have no allergies to aloe vera or alumina, no inflammatory bowel disease, skin disorders/allergies, recent pain medication use, abnormal forearm skin, neurological conditions affecting sensation/perception of pain.Check my eligibility
What is being tested?
The trial tests the application of STAR particles—tiny microneedle-covered particles—to see how they create punctures in the skin and enhance topical medication effectiveness. No active medications are used; it's about finding the best method to apply these particles on arm and hand areas.See study design
What are the potential side effects?
Potential side effects may include discomfort at the application site due to microneedles creating punctures in the skin. There might also be temporary redness or swelling where STAR particles are applied.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before application, 20 minutes after application, and 30 minutes after application
This trial's timeline: 3 weeks for screening, Varies for treatment, and before application, 20 minutes after application, and 30 minutes after application for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in conditions for the administration of STAR particles to penetrate the stratum corneum
Secondary outcome measures
Assess standard adverse event (AE)
Evaluate the sensation and pain during and after application of STAR particle
Other outcome measures
Assess potential adverse events after removal

Trial Design

1Treatment groups
Experimental Treatment
Group I: STAR ParticlesExperimental Treatment1 Intervention
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.

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Who is running the clinical trial?

Emory UniversityLead Sponsor
1,640 Previous Clinical Trials
2,560,637 Total Patients Enrolled
Eric I Felner, MD, MSCRPrincipal InvestigatorEmory University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly individuals being sought to participate in this research?

"Participants of this clinical trial must be legally adults with ages between 18 and 39 years old."

Answered by AI

What demographics are eligible to participate in this research?

"Applicants must be within the 18 to 39 age range and have no pre-existing medical conditions in order to take part in this trial. The team is targeting a maximum of 20 participants for enrollment."

Answered by AI

Are additional participants being sought for this trial?

"According to the data hosted on clinicaltrials.gov, this particular study is no longer recruiting patients; the trial was first posted September 1st 2023 and had its last update August 16th 2023. Fortunately for those seeking medical trials, there are 834 different studies actively enrolling individuals at this time."

Answered by AI

Who else is applying?

What site did they apply to?
Emory Children's Center
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Looking to make a little extra money and I'm a healthy subject.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Aldena STAR Particles
Eric Felner 2024. "Aldena STAR Particles". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06004973.
~10 spots leftby Jul 2024
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