Vtama in Psoriasis Patients Being Treated With Biologics.

October 19, 2023 updated by: Jerry Bagel, Psoriasis Treatment Center of Central New Jersey

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • East Windsor, New Jersey, United States, 08520
        • Schweiger Derm Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. ≤3% BSA
  2. Patient not receiving biologic agent, or receiving biologic agent <24weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Vtama
open label Vtama
Drug: Tapinarof
Add on Vtama (tapinarof) to biololgic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body surface area ≤1%
Time Frame: 12 weeks
Patients who achieve body surface area of ≤1%
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Psoriasis Treatment Center of Central New Jersey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2023

Primary Completion (Actual)

October 18, 2023

Study Completion (Actual)

October 18, 2023

Study Registration Dates

First Submitted

October 19, 2023

First Submitted That Met QC Criteria

October 19, 2023

First Posted (Actual)

October 27, 2023

Study Record Updates

Last Update Posted (Actual)

October 27, 2023

Last Update Submitted That Met QC Criteria

October 19, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTC10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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