Visualization of Topical Zoryve vs. Vehicle Using Line Field Optical Coherence Tomography in Healthy Skin
Rao Dermatology
Summary
The goal of this study is to visualize the deposition of topical 0.3% 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 0.3% 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.
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 0.3% 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 top…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Healthy subjects over 18 years of age from the outpatient dermatology clinic, Rao Dermatology. All subjects must have provided written informed consent. Exclusion Criteria: * Subjects with a history of immune-mediated skin conditions will be excluded from participation. Additionally, participants who have received systemic therapy within the last 60 days will not be eligible. Those using topical therapy must have discontinued their current treatment for a minimum of seven days prior to enrollment.
Interventions
- DrugRoflumilast
Roflumilast 0.3% cream
- OtherVehicle (Roflumilast 0.3% vehicle cream)
Vehicle (Roflumilast 0.3% vehicle cream)
Location
- Rao DermatologyAtlantic Highlands, New Jersey