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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Skin
• Intervention / Treatment: Drug: Roflumilast; Other: Vehicle (Roflumilast 0.3% vehicle cream)

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 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 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 Type: Interventional
• Enrollment (Estimated): 3
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Bassem Rafiq, BS; Phone Number: 2403974368; Email: Rafiqbassem@gmail.com

Study Locations

• United States
  • New Jersey
    • Atlantic Highlands, New Jersey, United States, 07716
      • Recruiting
      • Rao Dermatology
      • Contact: Bassem Rafiq; Phone Number: 240-397-4368; Email: Rafiqbassem@gmail.com
      • Principal Investigator: Babar K Rao, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Vehicle	Other: Vehicle (Roflumilast 0.3% vehicle cream); Vehicle (Roflumilast 0.3% vehicle cream)
Active Comparator: Roflumilast	Drug: Roflumilast; Roflumilast 0.3% cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LC-OCT	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.	14 days

Collaborators and Investigators

• Sponsor: Rao Dermatology

Publications and helpful links

General Publications

• Pixley JN, Schaetzle T, Feldman SR. A Review of Topical Roflumilast for the Treatment of Plaque Psoriasis. Ann Pharmacother. 2023 Aug;57(8):966-969. doi: 10.1177/10600280221137750. Epub 2022 Nov 24.

Study record dates

Study Major Dates

• Study Start (Estimated): May 28, 2024
• Primary Completion (Estimated): June 28, 2024
• Study Completion (Estimated): July 28, 2024

Study Registration Dates

• First Submitted: May 28, 2024
• First Submitted That Met QC Criteria: May 28, 2024
• First Posted (Actual): June 3, 2024

Study Record Updates

• Last Update Posted (Actual): June 3, 2024
• Last Update Submitted That Met QC Criteria: May 28, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Pro00078950

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Results to be reported as pulled data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No