search
Back to results

A Study to Investigate Efficacy and Safety of VTAMA® (Tapinarof) Cream, 1% in Plaque Psoriasis in the Head and Neck Region

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
VTAMA (tapinarof) cream, 1%
Sponsored by
Dermavant Sciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Tapinarof, Plaque Psoriasis, Scalp Psoriasis, Psoriasis, Phase 4, Topical, Open-label, Efficacy, Safety, Adult, Face Psoriasis, Neck Psoriasis, Psoriatic conditions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18 years of age or older, at the time of signing the informed consent Participants with clinical diagnosis of plaque psoriasis, including lesion(s) in the head and neck region and stable disease in the head and neck region for at least 3 months prior to the study Participant has a plaque psoriasis lesion in the head and neck region that is suitable for evaluation as the target lesion and has a PGA (target lesion) score of 2 (Mild), 3 (Moderate), or 4 (Severe) at Screening and Baseline Female subjects of child bearing potential who are engaging in sexual activity that could lead to pregnancy agree to follow the specified contraceptive guidance throughout the study Negative pregnancy test at Baseline (Day 1) Capable of giving written informed consent Exclusion Criteria: Diagnosis of a type of psoriasis other than plaque psoriasis Any sign of infection of any of the psoriatic lesions Concurrent significant dermatologic or inflammatory condition other than plaque psoriasis that, in the Investigator's opinion, would make it difficult to interpret data or assessments during the study History of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the Investigator's opinion, may interfere with participation in the study and ability to understand and give informed consent History of sensitivity to the study product, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates participation in the study Previous known participation in a clinical study with tapinarof (previously known as GSK2894512 and WBI-1001); previous or current use of VTAMA® (Tapinarof) cream, 1% Use of any prohibited medication or procedure within the indicated period before the baseline visit including other investigational product within 30 days or 5 half-lives of the investigational product (whichever is longer) UV light therapy or prolonged exposure to natural or artificial sources of UV radiation (e.g., phototherapy, tanning beds/booths, or therapeutic sunbathing) within 4 weeks prior to the Baseline

Sites / Locations

  • Dermavant Investigative Site
  • Dermavant Investigative Site
  • Dermavant Investigative Sites
  • Dermavant Investigative Site
  • Dermavant Investigative Site
  • Dermavant Investigative Site
  • Dermavant Investigative Site
  • Dermavant Investigative Site
  • Dermavant Investigative Site
  • Dermavant Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VTAMA (tapinarof) cream, 1%

Arm Description

VTAMA (tapinarof) cream, 1% applied topically once daily

Outcomes

Primary Outcome Measures

Percentage of participants who achieve a target lesion Physician Global Assessment (PGA) score in the head and neck region of Clear (0) or Almost Clear (1) with a ≥ 2-grade improvement from Baseline to Week 12
Physician Global Assessment (PGA) is a clinical tool for assessing the current state/severity of a participant's psoriasis in a target lesion of the head and neck region at a given timepoint. It is a static 5-point assessment of plaque qualities on the clinical characteristics of erythema, scaling, and plaque thickness/elevation within the head and neck region. The PGA ranges from 0 to 4, and is assessed as Clear (0), Almost Clear (1), Mild (2), Moderate (3), and Severe (4). Higher PGA scores represent more severe disease.

Secondary Outcome Measures

Time to achieve a target lesion PGA score of Clear (0) or Almost Clear (1) with a ≥ 2-grade improvement
Physician Global Assessment (PGA) is a clinical tool for assessing the current state/severity of a participant's psoriasis in a target lesion of the head and neck region at a given timepoint. It is a static 5-point assessment of plaque qualities on the clinical characteristics of erythema, scaling, and plaque thickness/elevation within the head and neck region. The PGA ranges from 0 to 4, and is assessed as Clear (0), Almost Clear (1), Mild (2), Moderate (3), and Severe (4). Higher PGA scores represent more severe disease.

Full Information

First Posted
March 14, 2023
Last Updated
October 3, 2023
Sponsor
Dermavant Sciences, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05789576
Brief Title
A Study to Investigate Efficacy and Safety of VTAMA® (Tapinarof) Cream, 1% in Plaque Psoriasis in the Head and Neck Region
Official Title
A Phase 4, Open-label Study to Investigate the Efficacy and Safety of VTAMA® (Tapinarof) Cream, 1% in the Treatment of Plaque Psoriasis Occurring in the Head and Neck Region
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 13, 2023 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
July 19, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dermavant Sciences, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is an open-label, multi-center study to evaluate the efficacy and safety of VTAMA (tapinarof) cream, 1% in adults with plaque psoriasis occurring in the head and neck region
Detailed Description
This is an open-label study in which participants with plaque psoriasis in the head and neck region will be assigned to receive VTAMA (tapinarof) cream, 1% once daily for 12 weeks. Study participants will have a follow-up period of 1 week. The study duration will be up to 17 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Tapinarof, Plaque Psoriasis, Scalp Psoriasis, Psoriasis, Phase 4, Topical, Open-label, Efficacy, Safety, Adult, Face Psoriasis, Neck Psoriasis, Psoriatic conditions

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VTAMA (tapinarof) cream, 1%
Arm Type
Experimental
Arm Description
VTAMA (tapinarof) cream, 1% applied topically once daily
Intervention Type
Drug
Intervention Name(s)
VTAMA (tapinarof) cream, 1%
Intervention Description
VTAMA (tapinarof) cream, 1% applied topically once daily
Primary Outcome Measure Information:
Title
Percentage of participants who achieve a target lesion Physician Global Assessment (PGA) score in the head and neck region of Clear (0) or Almost Clear (1) with a ≥ 2-grade improvement from Baseline to Week 12
Description
Physician Global Assessment (PGA) is a clinical tool for assessing the current state/severity of a participant's psoriasis in a target lesion of the head and neck region at a given timepoint. It is a static 5-point assessment of plaque qualities on the clinical characteristics of erythema, scaling, and plaque thickness/elevation within the head and neck region. The PGA ranges from 0 to 4, and is assessed as Clear (0), Almost Clear (1), Mild (2), Moderate (3), and Severe (4). Higher PGA scores represent more severe disease.
Time Frame
from Baseline to Week 12
Secondary Outcome Measure Information:
Title
Time to achieve a target lesion PGA score of Clear (0) or Almost Clear (1) with a ≥ 2-grade improvement
Description
Physician Global Assessment (PGA) is a clinical tool for assessing the current state/severity of a participant's psoriasis in a target lesion of the head and neck region at a given timepoint. It is a static 5-point assessment of plaque qualities on the clinical characteristics of erythema, scaling, and plaque thickness/elevation within the head and neck region. The PGA ranges from 0 to 4, and is assessed as Clear (0), Almost Clear (1), Mild (2), Moderate (3), and Severe (4). Higher PGA scores represent more severe disease.
Time Frame
Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age or older, at the time of signing the informed consent Participants with clinical diagnosis of plaque psoriasis, including lesion(s) in the head and neck region and stable disease in the head and neck region for at least 3 months prior to the study Participant has a plaque psoriasis lesion in the head and neck region that is suitable for evaluation as the target lesion and has a PGA (target lesion) score of 2 (Mild), 3 (Moderate), or 4 (Severe) at Screening and Baseline Female subjects of child bearing potential who are engaging in sexual activity that could lead to pregnancy agree to follow the specified contraceptive guidance throughout the study Negative pregnancy test at Baseline (Day 1) Capable of giving written informed consent Exclusion Criteria: Diagnosis of a type of psoriasis other than plaque psoriasis Any sign of infection of any of the psoriatic lesions Concurrent significant dermatologic or inflammatory condition other than plaque psoriasis that, in the Investigator's opinion, would make it difficult to interpret data or assessments during the study History of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the Investigator's opinion, may interfere with participation in the study and ability to understand and give informed consent History of sensitivity to the study product, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates participation in the study Previous known participation in a clinical study with tapinarof (previously known as GSK2894512 and WBI-1001); previous or current use of VTAMA® (Tapinarof) cream, 1% Use of any prohibited medication or procedure within the indicated period before the baseline visit including other investigational product within 30 days or 5 half-lives of the investigational product (whichever is longer) UV light therapy or prolonged exposure to natural or artificial sources of UV radiation (e.g., phototherapy, tanning beds/booths, or therapeutic sunbathing) within 4 weeks prior to the Baseline
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Brown, MD, JD
Organizational Affiliation
Chief Medical Officer, Dermavant Sciences, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Dermavant Investigative Site
City
Macon
State/Province
Georgia
ZIP/Postal Code
31217
Country
United States
Facility Name
Dermavant Investigative Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60602
Country
United States
Facility Name
Dermavant Investigative Sites
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Dermavant Investigative Site
City
Auburn Hills
State/Province
Michigan
ZIP/Postal Code
48326
Country
United States
Facility Name
Dermavant Investigative Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Dermavant Investigative Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
Dermavant Investigative Site
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Dermavant Investigative Site
City
Kew Gardens
State/Province
New York
ZIP/Postal Code
11415
Country
United States
Facility Name
Dermavant Investigative Site
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
Country
United States
Facility Name
Dermavant Investigative Site
City
Arlington
State/Province
Texas
ZIP/Postal Code
76014
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study to Investigate Efficacy and Safety of VTAMA® (Tapinarof) Cream, 1% in Plaque Psoriasis in the Head and Neck Region

We'll reach out to this number within 24 hrs