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Topical Agent
A Study to Investigate Efficacy and Safety of VTAMA® (Tapinarof) Cream, 1% in Plaque Psoriasis in the Head and Neck Region
Phase 4
Waitlist Available
Research Sponsored by Dermavant Sciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 12
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved
Summary
This trial is testing a cream called VTAMA that contains 1% tapinarof. It is aimed at adults who have plaque psoriasis on their head and neck. The cream works by calming the skin and reducing the overproduction of skin cells, which helps with the red and scaly patches.
Eligible Conditions
- Psoriasis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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
Secondary study objectives
Time to Achieve a Target Lesion PGA Score of Clear (0) or Almost Clear (1) With a ≥ 2-grade Improvement
Side effects data
From 2023 Phase 4 trial • 31 Patients • NCT0578957623%
Dermatitis contact
19%
Folliculitis
16%
Headache
6%
Sinusitis
6%
Seborrheic keratosis
3%
Rectal haemorrhage
3%
Anaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
VTAMA (Tapinarof) Cream, 1%
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
1Treatment groups
Experimental Treatment
Group I: VTAMA (tapinarof) cream, 1%Experimental Treatment1 Intervention
VTAMA (tapinarof) cream, 1% applied topically once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VTAMA (tapinarof) cream, 1%
2023
Completed Phase 4
~40
Find a Location
Who is running the clinical trial?
Dermavant Sciences, Inc.Lead Sponsor
8 Previous Clinical Trials
1,757 Total Patients Enrolled
3 Trials studying Psoriasis
174 Patients Enrolled for Psoriasis
Philip Brown, MD, JDStudy DirectorChief Medical Officer, Dermavant Sciences, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a type of psoriasis that is different from plaque psoriasis.You have received UV light therapy or spent a lot of time in the sun or tanning beds in the past 4 weeks.You have been diagnosed with plaque psoriasis, including lesions on your head and neck, and your condition has been stable for at least 3 months before the study.
Research Study Groups:
This trial has the following groups:- Group 1: VTAMA (tapinarof) cream, 1%
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.