Brief Summary

This is an open-label, multicenter study to evaluate the systemic exposure and safety of topical tapinarof cream, 1% under conditions of maximal use in adults with plaque psoriasis.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

Completed

Started Jul 2019

Shorter than P25 for phase_2

Geographic Reach

1 country

6 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6 months study duration

Study Start

First participant enrolled

July 23, 2019

Completed

1 day until next milestone

First Submitted

Initial submission to the registry

July 24, 2019

Completed

8 days until next milestone

First Posted

Study publicly available on registry

August 1, 2019

Completed

5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2020

Completed

2.3 years until next milestone

Results Posted

Study results publicly available

May 6, 2022

Completed

Last Updated

June 19, 2025

Status Verified

May 1, 2022

Enrollment Period

6 months

First QC Date

July 24, 2019

Results QC Date

August 17, 2021

Last Update Submit

May 30, 2025

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (6)

Number of Participants That Experienced Adverse Events (AEs), Severe Adverse Events, and Serious Adverse Events (SAEs)
Frequency and severity of AEs (local and systemic)
Baseline to Week 4
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Biomarker Values, ECG Results or Vital Signs
Changes in laboratory values, biomarker values, ECG results and vital signs were assessed for clinical relevance.
Baseline to Week 4 or Follow-Up (7-10 days after Week 4 Visit)
Number of Participants With Irritation as Assessed by the Local Tolerability Scale
At each specified study visit, the Investigator (or qualified evaluator) assessed the presence and overall degree of irritation at the application sites, according to the LTS. The score will ideally represent an 'average' across all application sites. To the fullest extent possible, the same Investigator (or designated evaluator) will perform all tolerability assessments for an individual participant throughout the study.
Day 1, Day 15, Day 29
Tapinarof and Tapinarof Sulfate (Metabolite) Plasma PK Parameters on Day 1 and Day 29: AUCo-tau
The AUC in plasma is a pharmacokinetic parameter that describes the overall exposure of the drug.
Day 1 and Day 29 (PK samples collected at pre-dose and at 1, 2, 3, 4, 5, 8, 12, and 24 hours after dosing)
Tapinarof and Tapinarof Sulfate (Metabolite) Plasma PK Parameters on Day 1 and Day 29: Cmax
The Cmax is a pharmacokinetic parameter that describes the highest concentration of the drug that is achieved after dosing.
Day 1 and Day 29 (PK samples collected at pre-dose and at 1, 2, 3, 4, 5, 8, 12, and 24 hours after dosing)
Tapinarof and Tapinarof Sulfate (Metabolite) Plasma PK Parameters on Day 1 and Day 29: Tmax and t1/2
The tmax is a pharmacokinetic parameter that describes the time point at which the highest concentration of the drug is achieved after dosing.
Day 1 and Day 29 (PK samples collected at pre-dose and at 1, 2, 3, 4, 5, 8, 12, and 24 hours after dosing)

Secondary Outcomes (5)

Change From Baseline in QTcF (ΔQTcF) at Each Post-treatment Time Point on the Sampling Day With the Higher Cmax (Day 1 or Day 29)
Baseline and Day 1
Analysis of the Relationship Between Plasma Concentration and ΔQTcF
Day 1
Mean Change From Baseline to Day 29 in Physician's Global Assessment (PGA)
Baseline to Day 29
Mean Change From Baseline to Day 29 Psoriasis Area and Severity Index (PASI)
Baseline to Day 29
Mean Change From Baseline to Day 29 in Percent of Total Body Surface Area (%BSA) Affected
Baseline to Day 29

Study Arms (1)

Tapinarof (DMVT-505) cream, 1%

EXPERIMENTAL

Tapinarof (DMVT-505) cream, 1% applied topically once daily

Drug: Tapinarof cream, 1%

Interventions

Tapinarof cream, 1%DRUG

Tapinarof cream, 1% applied topically once daily

Also known as: DMVT-505

Tapinarof (DMVT-505) cream, 1%

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male and female subjects age 18 to 75 with a confirmed clinical diagnosis of plaque psoriasis and stable disease for at least 6 months prior to the study
BSA involvement ≥ 20%
PGA score of ≥ 3 at screening
Females of child bearing potential and male subjects who are engaging in sexual activity that could lead to pregnancy agree to follow the specified contraceptive guidance throughout the study
Capable of giving written informed consent

You may not qualify if:

Psoriasis other than plaque variant
Any sign of infection of any of the psoriatic lesions
Evidence of significant hepatic, renal, respiratory, endocrine, hematologic, neurologic, psychiatric, or cardiovascular (CV) system abnormalities or laboratory abnormality that will affect the health of the subject or interfere with the interpretation of the results
Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation within 4 weeks prior to the Baseline visit and/or plans to have such exposures during the study which could potentially impact the subject's psoriasis
Use of any prohibited medication within the indicated period before the first dose of study drug
Pregnant females or lactating females
The subject has received an investigational product within 30 days, 5 half-lives, or twice the duration of the biological effect of the study drug (whichever is longer) prior to first dose of study drug
Current or a history of cancer within 5 years except for fully excised skin basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix
Previous known participation in a clinical study with tapinarof

Contact the study team to confirm eligibility.