Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06004973
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2023-06-18
Brief Title:
Aldena STAR Particles
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Usability of STAR Particles in Healthy Volunteers A Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 for the collection of medical information and assessing eligibility in the study The second visit will have the application of STAR particles on different areas of the arm and hand with different pressures to see 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
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 for the collection of medical information and assessing eligibility in the study The second visit will have the application of STAR particles on different areas of the arm and hand with different pressures to see 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 indications are treated through the topical application of a therapeutic compound formulated into a gel cream ointment or lotion eg eczema psoriasis actinic keratosis cutaneous warts etc This is especially true in dermatology in which the skin is often the primary site of action Topicals ie drugs applied to the skins surface allow patients to easily self-apply these therapies without the need for painful or difficult-to-use medical technologies eg hypodermic needles or the risks associated with systemic exposure to a drug eg oral intravenous or intramuscular administration
Despite the advantages associated with topical delivery the skin serves as a barrier in the transport of most external compounds There are several techniques to overcome the skin barrier There have been several studies to increase skin permeability such as chemical biochemical and physical methods However chemical and biochemical methods do not appear to be broadly useful for the delivery of large molecule therapeutics eg 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 on 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
Many medical indications are treated through the topical application of a therapeutic compound formulated into a gel cream ointment or lotion eg eczema psoriasis actinic keratosis cutaneous warts etc This is especially true in dermatology in which the skin is often the primary site of action Topicals ie drugs applied to the skins surface allow patients to easily self-apply these therapies without the need for painful or difficult-to-use medical technologies eg hypodermic needles or the risks associated with systemic exposure to a drug eg oral intravenous or intramuscular administration
Despite the advantages associated with topical delivery the skin serves as a barrier in the transport of most external compounds There are several techniques to overcome the skin barrier There have been several studies to increase skin permeability such as chemical biochemical and physical methods However chemical and biochemical methods do not appear to be broadly useful for the delivery of large molecule therapeutics eg 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 on 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None