Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2024P008520 | Other Identifier | Emory IRB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STAR Particles | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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)]. | Before application, 20 minutes after application, and 30 minutes after application |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately After STAR particles application |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience Adverse Events Due to Residual STAR Particles | Participants will perform a visual inspection of the residual STAR particles after their removal and report any adverse events due to residual STAR particles up to 30 days after removal. | After STAR particles removal up to 30 days (for a total of 30 days) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eric I Felner, MD, MSCR | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Children's Center | Atlanta | Georgia | 30322 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
This was an ADAPTIVE STUDY DESIGN so that after reviewing the data collected from the first 10 participants (Part 1), conditions were altered so that the ideal conditions (cycles and pressure application) discovered from Part 1 (first 10 participants) would be used for the next 10 participants (11 - 20) in Part 2 of the study. In Part 2, each subject had STARs applied to the right head/face and the right forearm, and a control was applied to the left head/face and the left forearm.
Participants were recruited in Atlanta, Georgia, USA. Participant enrollment began February 7, 2024, and all follow-up was complete by December 7, 2024.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | STAR Particles Part 1 | 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. STAR Particles: 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) and 100 mg of aloe vera will be applied to the control site on one of the forearms. Two rubbing cycles (20 and 30 cycles at 1 cycle/second) and three pressures (40, 60, and 80 kPa) will be evaluated. |
| FG001 | STAR Particle Part 2 | Participants in Part 2 will receive the STAR particle applications (one on the forearm and one on the side of the face) and one control application on the other forearm and on the other side of the face. STAR Particles: 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), and 100 mg of aloe vera will be applied to the control site on one of the forearms. Two rubbing cycles (60 cycles at 1 cycle/second and 80 kPa) will be evaluated. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1 (Participants 1-10) |
| ||||||||||||||||||||||||||||||||||||||||
| Part 2 (Participants 11-20) |
|
Twenty participants enrolled: Participants 1-10 (9 application sites each) were used to determine ideal pressure & TEWL. Participants 11-20 had pain and sensation assessed at the forearms and face at the pressure and cycle levels previously chosen from the first 10 enrolled participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | STAR Particles Part 1 | Part 1 (Participants 1-10): Each participant received eight interventions (different application pressures) plus one control. Sites and treatments were not randomly assigned to arms; the investigator administered all applications. |
| BG001 | STAR Particles Part 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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)]. | Participants 1-10, who had TEWL measurements. | Posted | Mean | Standard Deviation | g/m^2/hr | Before application, 20 minutes after application, and 30 minutes after application |
|
Information on adverse events was collected from the time of STAR particles application until 30 days after their removal, for a total observation period of 30 days.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | STAR Particles Part 1 | 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. STAR Particles: 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) and 100 mg of aloe vera will be applied to the control site on one of the forearms. Two rubbing cycles (20 and 30 cycles at 1 cycle/second) and three pressures (40, 60, and 80 kPa) will be evaluated. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric I Felner, MD, MSCR, Professor of Pediatrics | Emory University | 404-785-0935 | efelner@emory.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 22, 2024 | Oct 23, 2025 | Prot_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Gel without STAR Particles | Device | 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). |
|
|
| 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. |
| 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. | Up to 5 days after the STAR particles removal (for a total of 5 days) |
| STAR Particles on the Right Face (Forehead) |
|
| Control Gel Application without STAR Particles on the Left Arm |
|
| Control Gel Application without STAR Particles on the Left head (Forehead) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Part 2 (Participants 11-20): Conditions were adjusted based on the findings from Part 1, so that the optimal cycles and pressure application identified earlier could be applied. Each participant received STAR applications to the right head/face and right forearm, and a control application to the left head/face and left forearm. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Site 2 -STAR Particles on Right Forearm, 60 Rubbing Cycles/Min at 60 kPa Pressure | Site 2 -STAR Particles on Right forearm, 60 Rubbing Cycles/min at 60 kPa pressure Participants 1-10 will receive the 8 interventions (different application pressures) plus the control (Site and treatment will not be randomly assigned to an arm) from the investigator. STAR Particles: 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), and 100 mg of aloe vera will be applied to the control site on one of the forearms. Two rubbing cycles (20 and 30 cycles at 1 cycle/second) and three pressures (40, 60, and 80 kPa) will be evaluated. |
| OG002 | Site 3: STAR Particles on Right Forearm, 60 Rubbing Cycles/Min at 80 kPa | Site 3: STAR particles on Right forearm, 60 Rubbing Cycles/Min at 80 kPa Participants 1-10 will receive the 8 interventions (different application pressures) plus the control (Site and treatment will not be randomly assigned to an arm) from the investigator. STAR Particles: 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), and 100 mg of aloe vera will be applied to the control site on one of the forearms. Two rubbing cycles (20 and 30 cycles at 1 cycle/second) and three pressures (40, 60, and 80 kPa) will be evaluated. |
| OG003 | Site 4: Control Gel on Left Forearm, 30 Rubbing Cycles/Min at 60 kPa Pressure | Site 4: Control Gel: Left forearm, 30 Rubbing Cycles/Min at 60 kPa pressure Participants 1-10 will receive the 8 interventions (different application pressures) plus the control (Site and treatment will not be randomly assigned to an arm) from the investigator. STAR Particles: 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), and 100 mg of aloe vera will be applied to the control site on one of the forearms. Two rubbing cycles (20 and 30 cycles at 1 cycle/second) and three pressures (40, 60, and 80 kPa) will be evaluated. |
| OG004 | Site 5: STAR Particles on Left Forearm, 30 Rubbing Cycles/Min at 80 kPa Pressure | Site 5: STAR Particles on Left forearm, 30 Rubbing Cycles/Min at 80 kPa pressure Participants 1-10 will receive the 8 interventions (different application pressures) plus the control (Site and treatment will not be randomly assigned to an arm) from the investigator. STAR Particles: 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), and 100 mg of aloe vera will be applied to the control site on one of the forearms. Two rubbing cycles (20 and 30 cycles at 1 cycle/second) and three pressures (40, 60, and 80 kPa) will be evaluated. |
| OG005 | Site 6: STAR Particles on Left Forearm, 30 Rubbing Cycles/Min at 60 kPa Pressure | Site 6: STAR Particles on Left forearm, 30 Rubbing Cycles/Min at 60 kPa pressure Participants 1-10 will receive the 8 interventions (different application pressures) plus the control (Site and treatment will not be randomly assigned to an arm) from the investigator. STAR Particles: 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), and 100 mg of aloe vera will be applied to the control site on one of the forearms. Two rubbing cycles (20 and 30 cycles at 1 cycle/second) and three pressures (40, 60, and 80 kPa) will be evaluated. |
| OG006 | SITE 7: STAR Particles on Left Forearm, 30 Rubbing Cycles/Min at 40 kPa Pressure. | SITE 7: STAR particles on Left forearm, 30 Rubbing Cycles/Min at 40 kPa pressure. Participants 1-10 will receive the 8 interventions (different application pressures) plus the control (Site and treatment will not be randomly assigned to an arm) from the investigator. STAR Particles: 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), and 100 mg of aloe vera will be applied to the control site on one of the forearms. Two rubbing cycles (20 and 30 cycles at 1 cycle/second) and three pressures (40, 60, and 80 kPa) will be evaluated. |
| OG007 | Site 8: STAR Particles on the Palm of the Right Hand at 30 Rubbing Cycles/Minute at 60 kPa Pressure | Site 8: STAR Particles on the Palm of the Right Hand at 30 Rubbing Cycles/Minute at 60 kPa Pressure Participants 1-10 will receive the 8 interventions (different application pressures) plus the control (Site and treatment will not be randomly assigned to an arm) from the investigator. STAR Particles: 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), and 100 mg of aloe vera will be applied to the control site on one of the forearms. Two rubbing cycles (20 and 30 cycles at 1 cycle/second) and three pressures (40, 60, and 80 kPa) will be evaluated. |
| OG008 | Site 9: STAR Particles on the Dorsum of the Right Hand, 30 Rubbing Cycles/Min at 60 kPa Pressure | Site 9: STAR Particles on the dorsum of the Right Hand, 30 Rubbing Cycles/Min at 60 kPa pressure Participants 1-10 will receive the 8 interventions (different application pressures) plus the control (Site and treatment will not be randomly assigned to an arm) from the investigator. STAR Particles: 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), and 100 mg of aloe vera will be applied to the control site on one of the forearms. Two rubbing cycles (20 and 30 cycles at 1 cycle/second) and three pressures (40, 60, and 80 kPa) will be evaluated. |
|
|
| Secondary | 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. | Sensation was evaluated only among participants in Part 2 of the STAR Particles study (Participants 11-20). | Posted | Mean | Standard Deviation | score on a Likert scale | Immediately After STAR particles application |
|
|
|
| Secondary | 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. | VAPS was evaluated only among participants in Part 2 of the STAR Particles study (Participants 11-20). For each participant, all application sites on the right arm were assessed, and the results were aggregated into a single value. Similarly, all application sites on the right side of the face were assessed and reported as a separate aggregated result. | Posted | Mean | Standard Deviation | score on a scale | Immediately After STAR particles application |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Up to 5 days after the STAR particles removal (for a total of 5 days) |
|
|
|
| Other Pre-specified | Number of Participants Who Experience Adverse Events Due to Residual STAR Particles | Participants will perform a visual inspection of the residual STAR particles after their removal and report any adverse events due to residual STAR particles up to 30 days after removal. | Because no serious adverse events (SAEs) occurred and the safety profile was consistent across all sites and study parts, safety data are reported in aggregate for all participants rather than by individual site or part. This approach was chosen to simplify reporting without compromising accuracy. | Posted | Count of Participants | Participants | After STAR particles removal up to 30 days (for a total of 30 days) |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | STAR Particles Part 2 | Participants will receive eight applications (one on the forearm and one on the side of the face of STAR particles, and one control application on the other forearm and on the other side of the face).STAR Particles: 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), and 100 mg of aloe vera will be applied to the control site on one of the forearms. Two rubbing cycles (60 cycles at 1 cycle/second and 80 kPa) will be evaluated. | 0 | 10 | 0 | 10 | 0 | 10 |
Not provided
Not provided
Not provided