Trial Outcomes & Findings for A Study to Investigate Efficacy and Safety of VTAMA® (Tapinarof) Cream, 1% in Plaque Psoriasis in the Head and Neck Region (NCT NCT05789576)

Last Updated: 2025-06-12

Results Overview

Physician Global Assessment (PGA) is a clinical tool for assessing the current state/severity of a participant's psoriasis in a target lesion of the head and neck region 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 head and neck region. The PGA ranges from 0 to 4, and is assessed as Clear (0), Almost Clear (1), Mild (2), Moderate (3), and Severe (4). Higher PGA scores represent more severe disease.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

31 participants

Primary outcome timeframe

from Baseline to Week 12

Results posted on

2025-06-12

Participant Flow

Participant milestones

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	31
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VTAMA (Tapinarof) Cream, 1% n=31 Participants VTAMA (tapinarof) cream, 1% applied topically once daily VTAMA (tapinarof) cream, 1%: VTAMA (tapinarof) cream, 1% applied topically once daily
Age, Continuous	55.5 years STANDARD_DEVIATION 16.90 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 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	1 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	1 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants
PGA (Target Lesion) 0 - Clear	0 Participants n=5 Participants
PGA (Target Lesion) 1 - Almost Clear	0 Participants n=5 Participants
PGA (Target Lesion) 2 - Mild	12 Participants n=5 Participants
PGA (Target Lesion) 3 - Moderate	17 Participants n=5 Participants
PGA (Target Lesion) 4 - Severe	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: from Baseline to Week 12

Population: Observed cases

Outcome measures

Outcome measures
Measure	VTAMA (Tapinarof) Cream, 1% n=26 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 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	23 Participants

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: Observed cases

Outcome measures

Outcome measures
Measure	VTAMA (Tapinarof) Cream, 1% n=31 Participants VTAMA (tapinarof) cream, 1% applied topically once daily VTAMA (tapinarof) cream, 1%: VTAMA (tapinarof) cream, 1% applied topically once daily
Time to Achieve a Target Lesion PGA Score of Clear (0) or Almost Clear (1) With a ≥ 2-grade Improvement	29.0 days Interval 15.0 to 53.0

Adverse Events

VTAMA (Tapinarof) Cream, 1%

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	VTAMA (Tapinarof) Cream, 1% n=31 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 Rectal haemorrhage	3.2% 1/31 • Number of events 1 • 13 weeks
Blood and lymphatic system disorders Anaemia	3.2% 1/31 • Number of events 1 • 13 weeks

Other adverse events

Other adverse events
Measure	VTAMA (Tapinarof) Cream, 1% n=31 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	19.4% 6/31 • Number of events 6 • 13 weeks
Infections and infestations Sinusitis	6.5% 2/31 • Number of events 2 • 13 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrheic keratosis	6.5% 2/31 • Number of events 2 • 13 weeks
Nervous system disorders Headache	16.1% 5/31 • Number of events 5 • 13 weeks
Skin and subcutaneous tissue disorders Dermatitis contact	22.6% 7/31 • Number of events 8 • 13 weeks

Additional Information

Clinical Lead, Late-Stage Clinical Development

Organon and Co

Phone: 551-430-6000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place