Clinical trial NCT05789576: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis
Keywords: Tapinarof
Plaque Psoriasis
Scalp Psoriasis
Psoriasis
Phase 4
Topical
Open-label
Efficacy
Safety
Adult
Face Psoriasis
Neck Psoriasis
Psoriatic conditions
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2023-03-29
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
timeFrame: from Baseline to Week 12
Secondary outcomes:
measure: Time to Achieve a Target Lesion PGA Score of Clear (0) or Almost Clear (1) With a ≥ 2-grade Improvement
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Macon
country: United States
facility: Dermavant Investigative Site
state: Georgia
city: Chicago
country: United States
facility: Dermavant Investigative Site
state: Illinois
city: Rockville
country: United States
facility: Dermavant Investigative Sites
state: Maryland
city: Auburn Hills
country: United States
facility: Dermavant Investigative Site
state: Michigan
city: Detroit
country: United States
facility: Dermavant Investigative Site
state: Michigan
city: Las Vegas
country: United States
facility: Dermavant Investigative Site
state: Nevada
city: Portsmouth
country: United States
facility: Dermavant Investigative Site
state: New Hampshire
city: Kew Gardens
country: United States
facility: Dermavant Investigative Site
state: New York
city: Marion
country: United States
facility: Dermavant Investigative Site
state: Ohio
city: Arlington
country: United States
facility: Dermavant Investigative Site
state: Texas
Study officials:
References: