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

NCT06440473 | Recruiting Phase 4 FDA Drug

• 1 other identifier: Pro00078950
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Skin

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Roflumilast

ACTIVE COMPARATOR

Drug: Roflumilast

Vehicle

PLACEBO COMPARATOR

Other: Vehicle (Roflumilast 0.3% vehicle cream)

Interventions

Roflumilast DRUG

Roflumilast 0.3% cream

Roflumilast

Vehicle (Roflumilast 0.3% vehicle cream) OTHER

Vehicle (Roflumilast 0.3% vehicle cream)

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subjects over 18 years of age from the outpatient dermatology clinic, Rao Dermatology. All subjects must have provided written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rao Dermatology: lead

Study Sites (1)

Rao Dermatology

Atlantic Highlands, New Jersey, 07716, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 36420929 BACKGROUND

MeSH Terms

Interventions

Roflumilast

Central Study Contacts

Bassem Rafiq, BS

CONTACT

2403974368; Rafiqbassem@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Owner

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 3, 2024
• Study Start: May 28, 2024
• Primary Completion: June 28, 2024
• Study Completion: July 28, 2024
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)