Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06440473
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-28
Brief Title:
Visualization of Topical Zoryve vs Vehicle Using Line Field Optical Coherence Tomography in Healthy Skin
Sponsor:
Rao Dermatology
Organization:
Rao Dermatology
Study Overview
Official Title:
Visualization of Topical Zoryve vs Vehicle Using Line Field Optical Coherence Tomography in Healthy Skin
Status:
RECRUITING
Status Verified Date:
2024-05
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 goal of this study is to visualize the deposition of topical 03 roflumilast Zoryve compared to vehicle using Line-Field Optical Coherence Tomography LC-OCT in vivo in healthy skin We hypothesize that the application of topical 03 roflumilast Zoryve will result in distinct patterns of deposition within the epidermal and dermal layers compared to the vehicle Specifically we anticipate observing deeper penetration and more uniform distribution of roflumilast within the skin layers indicative of enhanced efficacy as visualized by LC-OCT imaging
Detailed Description:
Primary Objective
Compare the deposition of Zoryve and the vehicle in the epidermal and dermal layers using LC-OCT
Primary Endpoint
The primary endpoint of this study is a visual qualitative analysis of LC-OCT images conducted by an expert confocalist Babar Rao MD This analysis aims to assess the penetration of the active drug product compared to the vehicle
Subjects will be instructed to apply topical 03 Zoryve once daily for seven consecutive days to a predetermined 2x2cm area on the dorsal surface forearm as defined by the investigator Additionally participants will apply a topical cream vehicle provided by Zoryve to the dorsall side of the opposite forearm Therefore one forearm will be designated for application of Zoryve while the other forearm will the designated for application of the topical cream vehicle supplied by Zoryve Subjects will apply the topical vehicle and roflumilast daily for 7 consecutive days LC-OCT imaging will be conducted on both arms at various time points baseline T0A 15 minutes T0B 1 hour T0C 8-12 hours T0D 24 hours T0E seven days after application T7 and seven days after not applying cream T14 LC-OCT imaging will follow a predefined image acquisition protocol with investigators designating 2x2cm areas for imaging The imaging protocol will include capturing 2D vertical photos 3D photos and 2D vertical videos per imaging site Participants will be instructed to photograph the imaging sites to aid in the accurate application of the active drug product or vehicle cream base
Compare the deposition of Zoryve and the vehicle in the epidermal and dermal layers using LC-OCT
Primary Endpoint
The primary endpoint of this study is a visual qualitative analysis of LC-OCT images conducted by an expert confocalist Babar Rao MD This analysis aims to assess the penetration of the active drug product compared to the vehicle
Subjects will be instructed to apply topical 03 Zoryve once daily for seven consecutive days to a predetermined 2x2cm area on the dorsal surface forearm as defined by the investigator Additionally participants will apply a topical cream vehicle provided by Zoryve to the dorsall side of the opposite forearm Therefore one forearm will be designated for application of Zoryve while the other forearm will the designated for application of the topical cream vehicle supplied by Zoryve Subjects will apply the topical vehicle and roflumilast daily for 7 consecutive days LC-OCT imaging will be conducted on both arms at various time points baseline T0A 15 minutes T0B 1 hour T0C 8-12 hours T0D 24 hours T0E seven days after application T7 and seven days after not applying cream T14 LC-OCT imaging will follow a predefined image acquisition protocol with investigators designating 2x2cm areas for imaging The imaging protocol will include capturing 2D vertical photos 3D photos and 2D vertical videos per imaging site Participants will be instructed to photograph the imaging sites to aid in the accurate application of the active drug product or vehicle cream base
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None