PsoriasisPhase 4NCT06103695

Vtama in Psoriasis Patients Being Treated With Biologics.

A Phase 4 study testing Tapinarof in people with Psoriasis, run by Psoriasis Treatment Center of Central New Jersey at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Open label study to assess 12 weeks of add-on VTAMA® (tapinarof) Cream, 1% QD in patients with ≥3% BSA who have received biologic therapy for at least 24 weeks. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Psoriasis
What is being tested?: Tapinarof
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 27 Feb 2023to 18 Oct 2023
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
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female adult ≥ 18 years of age;
Diagnosis of chronic plaque-type
Patient with ≥3% BSA
Patient has been treated with biologic for a minimum of 24 weeks
Able and willing to give written informed consent prior to performance of any study-related procedures.

Who cannot join

≤3% BSA
Patient not receiving biologic agent, or receiving biologic agent <24weeks

Trial locations and contacts

1 site in 1 country.

United States1 site

Schweiger Derm Group
East Windsor, New Jersey, 08520

Other trials in United States

About this study

Official title: Open Label, Observational Study, Evaluating VTAMA® (Tapinarof) Cream, 1% QD in Psoriasis Patients Being Treated With Biologic Agents.

Open label study to assess 12 weeks of add-on VTAMA® (tapinarof) Cream, 1% QD in patients with ≥3% BSA who have received biologic therapy for at least 24 weeks.

Conditions: Psoriasis
Being tested: Tapinarof
Medical subject headings: Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TapinarofDrug
Add on Vtama (tapinarof) to biololgic therapy

Study groups in NCT06103695
Study group	Role	What they receive
Vtama	Other	open label Vtama Receives: Drug: Tapinarof

What is being measured

The primary outcome is the main question the study is designed to answer.

Body surface area ≤1%
Patients who achieve body surface area of ≤1%
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Feb 202318 Oct 2023

First posted27 Oct 2023
Study start27 Feb 2023
Primary completion18 Oct 2023
Study completion18 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PsoriasisStudies 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: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: open label
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06103695
Sponsor's protocol ID: PTC10
Status last verified: Oct 2023
First submitted: 19 Oct 2023
Last updated: 27 Oct 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
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Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
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All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open Label, Observational Study, Evaluating VTAMA® (Tapinarof) Cream, 1% QD in Psoriasis Patients Being Treated With Biologic Agents.
ClinicalTrials.gov ID: NCT06103695
Acronym / sponsor ID: PTC10
Conditions: Psoriasis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Psoriasis Treatment Center of Central New JerseyUniversity, hospital or other
Study start: 27 Feb 2023 (actual)
Primary completion: 18 Oct 2023 (actual)
Study completion: 18 Oct 2023 (actual)
First posted: 27 Oct 2023 (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.

Open label study to assess 12 weeks of add-on VTAMA® (tapinarof) Cream, 1% QD in patients with ≥3% BSA who have received biologic therapy for at least 24 weeks.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: open label

Arm	Type	Receives
Vtama	Other	Drug: Tapinarofopen label Vtama

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Male or female adult ≥ 18 years of age;
Diagnosis of chronic plaque-type
Patient with ≥3% BSA
Patient has been treated with biologic for a minimum of 24 weeks
Able and willing to give written informed consent prior to performance of any study-related procedures.

Key exclusion criteria (2 listed)

≤3% BSA
Patient not receiving biologic agent, or receiving biologic agent <24weeks

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
TapinarofAdd on Vtama (tapinarof) to biololgic therapy	Drug	Vtama

Primary outcome

Body surface area ≤1%
Time frame: 12 weeks
Patients who achieve body surface area of ≤1%

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
Individual participant dataSharing planned: No

Related trials for Psoriasis

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

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.

The record lists no contact. Use the official record to reach the sponsor.

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 Tapinarof in people with Psoriasis, run by Psoriasis Treatment Center of Central New Jersey 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 27 Oct 2023. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body surface area ≤1% (time frame: 12 weeks). 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 NCT06103695.

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 27 Oct 2023; AzTrials last refreshed its copy on 7 Nov 2026.