Comparing the skin absorption of Zoryve and a placebo cream
Visualization of Topical Zoryve vs. Vehicle Using Line Field Optical Coherence Tomography in Healthy Skin
This study is testing how well a new skin cream called Zoryve is absorbed into healthy skin compared to a regular cream by having participants apply both creams on their arms for a week.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 3 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rao Dermatology Academic / other |
| Locations | 1 site (Atlantic Highlands, New Jersey) |
| Trial ID | NCT06440473 on ClinicalTrials.gov |
What this trial studies
This study aims to visualize how well topical 0.3% roflumilast (Zoryve) penetrates healthy skin compared to a vehicle cream using Line-Field Optical Coherence Tomography (LC-OCT). Participants will apply Zoryve to one forearm and the vehicle to the other for seven consecutive days. The primary endpoint is a qualitative analysis of LC-OCT images to assess the drug's penetration in the skin layers. Imaging will occur at various time points to capture the absorption patterns of both treatments.
Who should consider this trial
Good fit: Ideal candidates are healthy adults over 18 years old who can provide informed consent.
Not a fit: Patients with a history of immune-mediated skin conditions or those currently using systemic or topical therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of how Zoryve is absorbed in the skin, potentially leading to improved treatment strategies for skin conditions.
How similar studies have performed: While similar studies have explored drug penetration in skin, this specific approach using LC-OCT for Zoryve is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Atlantic Highlands, New Jersey
- Rao Dermatology — Atlantic Highlands, New Jersey, United States (Recruiting)
Study contacts
- Study coordinator: Bassem Rafiq, BS
- Email: Rafiqbassem@gmail.com
- Phone: 2403974368
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.