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

Organon

Status and phase

Completed

Phase 4

Conditions

Psoriasis

Treatments

Drug: VTAMA (tapinarof) cream, 1%

Study type

Interventional

Funder types

Industry

Identifiers

NCT05789576

DMVT-505-4002

Details and patient eligibility

About

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

Full 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.

Enrollment

31 patients

Sex

All

Ages

18+ years old

Volunteers

No 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