Visualization of Topical Zoryve vs. Vehicle Using Line Field Optical Coherence Tomography in Healthy Skin

RECRUITING

I'm interested ...!!

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.

Conditions:

Healthy Skin

Study Start (Actual) 2024-05-28

Primary Completion (Estimated) 2024-06-28

Study Completion (Estimated) 2024-07-28

Enrollment (Estimated) 3

Study Type INTERVENTIONAL

Phase PHASE4

Locations:

📍 Atlantic Highlands, New Jersey, United States

Eligibility Criteria

Description

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.

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: Yes

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted2024-05-28
First Submitted that Met QC Criteria2024-05-28
First Posted2024-06-03

Study Record Updates

Last Update Submitted that Met QC Criteria2024-05-28
Last Update Posted2024-06-03
Last Verified2024-05