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

Part of paid clinical trials in Atlantic Highlands, New Jersey.

Sponsor
Rao Dermatology
Study ID
NCT06440473
Phase
PHASE4
Status
Unknown

Conditions

  • Healthy Skin

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
May 28, 2024
Status verified
May 2024
Primary completion
Jun 28, 2024
Completion
Jul 28, 2024

Study Design

Enrollment
3 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Roflumilast
  • Placebo Comparator: Vehicle

Primary Outcome Measure

LC-OCT [ Time Frame: 14 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rao DermatologyAtlantic HighlandsNew Jersey07716
Bassem Rafiq
[email protected]
240-397-4368
Babar K Rao, MD (PRINCIPAL_INVESTIGATOR)

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