Status:
COMPLETED
Aldena STAR Particles
Lead Sponsor:
Emory University
Conditions:
Healthy
Eligibility:
All Genders
18-39 years
Phase:
NA
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...
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 sk...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 7 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06004973
Start Date
February 7 2024
End Date
December 7 2024
Last Update
January 29 2025
Active Locations (1)
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1
Emory Children's Center
Atlanta, Georgia, United States, 30322