Healthy SkinPhase 4NCT06440473
Visualization of Topical Zoryve vs. Vehicle Using Line Field Optical Coherence Tomography in Healthy Skin
A Phase 4 study testing Roflumilast in people with Healthy Skin, run by Rao Dermatology at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Skin
- What is being tested?
- Roflumilast
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2024to 28 Jul 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects over 18 years of age from the outpatient dermatology clinic, Rao Dermatology. All subjects must have provided written informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Rao Dermatology
Atlantic Highlands, New Jersey, 07716
Bassem Rafiq, 240-397-4368, Rafiqbassem@gmail.com
Babar K Rao, MD
About this study
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.
Read the 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.
- Conditions
- Healthy Skin
- Being tested
- Roflumilast, Vehicle (Roflumilast 0.3% vehicle cream)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RoflumilastDrug
Roflumilast 0.3% cream
Vehicle (Roflumilast 0.3% vehicle cream)Other
Vehicle (Roflumilast 0.3% vehicle cream)
| Study group | Role | What they receive |
|---|---|---|
| Roflumilast | Active comparator | Not described Receives: Drug: Roflumilast |
| Vehicle | Placebo comparator | Not described Receives: Other: Vehicle (Roflumilast 0.3% vehicle cream) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start28 May 2024 (estimated)
- Primary completion28 Jun 2024 (estimated)
- Study completion28 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rao Dermatology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Babar Rao, Rao Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06440473
- Sponsor's protocol ID
- Pro00078950
- Status last verified
- May 2024
- First submitted
- 28 May 2024
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Results to be reported as pulled data
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.
PubMed 36420929
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visualization of Topical Zoryve vs. Vehicle Using Line Field Optical Coherence Tomography in Healthy Skin
- ClinicalTrials.gov ID
- NCT06440473
- Acronym / sponsor ID
- Pro00078950
- Conditions
- Healthy Skin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Rao DermatologyUniversity, hospital or other
- Study start
- 28 May 2024 (estimated)
- Primary completion
- 28 Jun 2024 (estimated)
- Study completion
- 28 Jul 2024 (estimated)
- First posted
- 3 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Roflumilast | Active comparator | Drug: Roflumilast |
| Vehicle | Placebo comparator | Other: Vehicle (Roflumilast 0.3% vehicle cream) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy subjects over 18 years of age from the outpatient dermatology clinic, Rao Dermatology. All subjects must have provided written informed consent.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RoflumilastRoflumilast 0.3% cream | Drug | Roflumilast |
| Vehicle (Roflumilast 0.3% vehicle cream)Vehicle (Roflumilast 0.3% vehicle cream) | Other | Vehicle |
Primary outcome
LC-OCT
Time frame: 14 days
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Background: PubMed 36420929Pixley 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.
- Individual participant dataSharing planned: No. Results to be reported as pulled data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Roflumilast in people with Healthy Skin, run by Rao Dermatology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bassem Rafiq, BS (2403974368, Rafiqbassem@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LC-OCT (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06440473, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2024.