Trial Outcomes & Findings for A Study to Investigate Efficacy and Safety of VTAMA (Tapinarof) Cream, 1% in Intertriginous Plaque Psoriasis (NCT NCT05680740)
NCT ID: NCT05680740
Last Updated: 2025-06-12
Results Overview
Intertriginous Physician Global Assessment (iPGA) is a clinical tool for assessing the current state/severity of a subject's psoriasis in the intertriginous areas 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 intertriginous areas. The iPGA ranges from 0 to 4, and is calculated as Clear (0), Almost Clear (1), Mild (2), Moderate (3), and Severe (4). Higher iPGA scores represent more severe disease.
COMPLETED
PHASE4
34 participants
from Baseline to Week 12
2025-06-12
Participant Flow
Participant milestones
| Measure |
VTAMA® (Tapinarof) Cream 1%
VTAMA® (tapinarof) Cream 1% applied topically once daily
VTAMA® (tapinarof) Cream 1%: VTAMA® (tapinarof) Cream 1% applied topically once daily
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Investigate Efficacy and Safety of VTAMA (Tapinarof) Cream, 1% in Intertriginous Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
VTAMA® (Tapinarof) Cream 1%
n=34 Participants
VTAMA® (tapinarof) Cream 1% applied topically once daily
VTAMA® (tapinarof) Cream 1%: VTAMA® (tapinarof) Cream 1% applied topically once daily
|
|---|---|
|
Age, Continuous
|
54.1 years
STANDARD_DEVIATION 15.88 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
|
Intertriginous PGA
0 - Clear
|
0 Participants
n=5 Participants
|
|
Intertriginous PGA
1 - Almost Clear
|
0 Participants
n=5 Participants
|
|
Intertriginous PGA
2 - Mild
|
10 Participants
n=5 Participants
|
|
Intertriginous PGA
3 - Moderate
|
22 Participants
n=5 Participants
|
|
Intertriginous PGA
4 - Severe
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: from Baseline to Week 12Population: Observed cases
Intertriginous Physician Global Assessment (iPGA) is a clinical tool for assessing the current state/severity of a subject's psoriasis in the intertriginous areas 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 intertriginous areas. The iPGA ranges from 0 to 4, and is calculated as Clear (0), Almost Clear (1), Mild (2), Moderate (3), and Severe (4). Higher iPGA scores represent more severe disease.
Outcome measures
| Measure |
VTAMA® (Tapinarof) Cream 1%
n=29 Participants
VTAMA® (tapinarof) Cream 1% applied topically once daily
VTAMA® (tapinarof) Cream 1%: VTAMA® (tapinarof) Cream 1% applied topically once daily
|
|---|---|
|
Percentage of Participants Who Achieve an Intertriginous PGA (iPGA) Score of Clear (0) or Almost Clear (1) With a ≥ 2-grade Improvement
|
24 Participants
|
SECONDARY outcome
Timeframe: from Baseline to Week 12Population: Observed cases
Intertriginous Physician Global Assessment (iPGA) is a clinical tool for assessing the current state/severity of a subject's psoriasis in the intertriginous areas 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 intertriginous areas. The iPGA ranges from 0 to 4, and is calculated as Clear (0), Almost Clear (1), Mild (2), Moderate (3), and Severe (4). Higher iPGA scores represent more severe disease.
Outcome measures
| Measure |
VTAMA® (Tapinarof) Cream 1%
n=25 Participants
VTAMA® (tapinarof) Cream 1% applied topically once daily
VTAMA® (tapinarof) Cream 1%: VTAMA® (tapinarof) Cream 1% applied topically once daily
|
|---|---|
|
Time to Achieve an iPGA Score of 0 or 1 With a ≥ 2 Grade Improvement
|
45.0 days
Interval 29.0 to 56.0
|
Adverse Events
VTAMA® (Tapinarof) Cream 1%
Serious adverse events
| Measure |
VTAMA® (Tapinarof) Cream 1%
n=34 participants at risk
VTAMA® (tapinarof) Cream 1% applied topically once daily
VTAMA® (tapinarof) Cream 1%: VTAMA® (tapinarof) Cream 1% applied topically once daily
|
|---|---|
|
Gastrointestinal disorders
Pancreatitis acute
|
2.9%
1/34 • Number of events 1 • 13 Weeks
|
|
Nervous system disorders
Ischaemic stroke
|
2.9%
1/34 • Number of events 1 • 13 Weeks
|
Other adverse events
| Measure |
VTAMA® (Tapinarof) Cream 1%
n=34 participants at risk
VTAMA® (tapinarof) Cream 1% applied topically once daily
VTAMA® (tapinarof) Cream 1%: VTAMA® (tapinarof) Cream 1% applied topically once daily
|
|---|---|
|
Infections and infestations
Folliculitis
|
23.5%
8/34 • Number of events 8 • 13 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
5.9%
2/34 • Number of events 2 • 13 Weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
8.8%
3/34 • Number of events 3 • 13 Weeks
|
Additional Information
Clinical Lead, Late-Stage Clinical Development
Organon and Co
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place