Recruiting

Zoryve vs. Vehicle

Sponsor:

Rao Dermatology

Code:

NCT06440473

Conditions

Healthy Skin

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Roflumilast

Vehicle (Roflumilast 0.3% vehicle cream)

Study Details

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

Study ID

NCT06440473

Start date

May 28, 2024

Status verified date

May, 2024

Completion date

Jul 28, 2024

Anticipated

Primary completion date

Jun 28, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

3 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Roflumilast

placebo comparator: Vehicle

Interventions

Roflumilast

Roflumilast 0.3% cream

Vehicle (Roflumilast 0.3% vehicle cream)

Vehicle (Roflumilast 0.3% vehicle cream)

Primary outcome measure

  • LC-OCT [ Time Frame: 14 days ]

Central Contacts and Locations

Central contacts

Bassem Rafiq, BS

2403974368Rafiqbassem@gmail.com

Locations

Rao Dermatology

Recruiting

Atlantic Highlands, New Jersey, United States, 07716

Contacts

Bassem Rafiq

240-397-4368Rafiqbassem@gmail.com

Principal Investigator:

Babar K Rao, MD

More Information

Sponsor

Rao Dermatology

Last update posted

Jun 3, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rao Dermatology on 2024-06-03.