Trial Outcomes & Findings for Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults (NCT NCT05014568)
NCT ID: NCT05014568
Last Updated: 2025-09-04
Results Overview
The vIGA-AD is a global assessment of the current state of the disease. It is a static 5-point scale used to grade overall disease severity (scalp excluded), as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. The vIGA-AD ranges from 0 to 4 and is calculated as Clear (0), Almost clear (1), Mild (2), Moderate (3), and Severe (4). Higher vIGA-AD scores represent more severe disease. Statistics are based on 100 imputed datasets.
COMPLETED
PHASE3
407 participants
Baseline to Week 8
2025-09-04
Participant Flow
Participants from the main study (DMVT-505-3101) had the option to participate in the open label extension study (DMVT-505-3103, NCT05142774).
Participant milestones
| Measure |
Tapinarof Cream
tapinarof cream, 1%, applied topically once daily
tapinarof cream, 1%: applied topically once daily
|
Vehicle Cream
vehicle cream, applied topically once daily
Vehicle cream: applied topically once daily
|
|---|---|---|
|
Overall Study
STARTED
|
270
|
137
|
|
Overall Study
COMPLETED
|
238
|
110
|
|
Overall Study
NOT COMPLETED
|
32
|
27
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults
Baseline characteristics by cohort
| Measure |
Tapinarof Cream
n=270 Participants
tapinarof cream, 1%, applied topically once daily
tapinarof cream, 1%: applied topically once daily
|
Vehicle Cream
n=137 Participants
vehicle cream, applied topically once daily
Vehicle cream: applied topically once daily
|
Total
n=407 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.6 years
STANDARD_DEVIATION 16.62 • n=5 Participants
|
15.6 years
STANDARD_DEVIATION 16.49 • n=7 Participants
|
15.6 years
STANDARD_DEVIATION 16.56 • n=5 Participants
|
|
Age, Customized
2-6 Years
|
76 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Age, Customized
7-11 Years
|
75 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Age, Customized
12-17 Years
|
67 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Age, Customized
≥ 18 Years
|
52 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
140 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
211 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
130 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
196 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
54 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
212 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
304 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
26 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
70 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
152 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
231 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
14 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
40 Count of participants
n=5 Participants
|
12 Count of participants
n=7 Participants
|
52 Count of participants
n=5 Participants
|
|
Region of Enrollment
United States
|
230 Count of participants
n=5 Participants
|
125 Count of participants
n=7 Participants
|
355 Count of participants
n=5 Participants
|
|
Validated Investigator Global Assessment for Atopic Dermatitis
0 - Clear
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Validated Investigator Global Assessment for Atopic Dermatitis
1 - Almost Clear
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Validated Investigator Global Assessment for Atopic Dermatitis
2 - Mild
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Validated Investigator Global Assessment for Atopic Dermatitis
3 - Moderate
|
244 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
366 Participants
n=5 Participants
|
|
Validated Investigator Global Assessment for Atopic Dermatitis
4 - Severe
|
26 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Percent Body Surface Area (BSA)
|
16.45 Percentage of Affected BSA
STANDARD_DEVIATION 8.666 • n=5 Participants
|
17.71 Percentage of Affected BSA
STANDARD_DEVIATION 9.500 • n=7 Participants
|
16.87 Percentage of Affected BSA
STANDARD_DEVIATION 8.964 • n=5 Participants
|
|
Eczema Area and Severity Index (EASI)
|
12.24 units on a scale
STANDARD_DEVIATION 5.007 • n=5 Participants
|
12.86 units on a scale
STANDARD_DEVIATION 5.633 • n=7 Participants
|
12.45 units on a scale
STANDARD_DEVIATION 5.228 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 8Population: ITT Population (MI Estimand)
The vIGA-AD is a global assessment of the current state of the disease. It is a static 5-point scale used to grade overall disease severity (scalp excluded), as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. The vIGA-AD ranges from 0 to 4 and is calculated as Clear (0), Almost clear (1), Mild (2), Moderate (3), and Severe (4). Higher vIGA-AD scores represent more severe disease. Statistics are based on 100 imputed datasets.
Outcome measures
| Measure |
Tapinarof Cream
n=270 Participants
tapinarof cream, 1%, applied topically once daily
tapinarof cream, 1%: applied topically once daily
|
Vehicle Cream
n=137 Participants
vehicle cream, applied topically once daily
Vehicle cream: applied topically once daily
|
|---|---|---|
|
Percent of Subjects Who Have a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Score of Clear or Almost Clear (0 or 1) With a Minimum 2-grade Improvement From Baseline to Week 8. Analyses Were Done Using Multiple Imputation.
|
45.4 Percentage of participants
|
13.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: ITT Population (MI Estimand)
The Eczema Area and Severity Index (EASI) is a scoring system that takes into account the overall severity of disease based on lesion severity and the extent of percent body surface area affected with atopic dermatitis. The EASI is a composite score ranging from 0 -72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the percent body surface area involved for each body region relative to the whole body. A higher EASI score represents more severe disease. Statistics are based on 100 imputed datasets.
Outcome measures
| Measure |
Tapinarof Cream
n=270 Participants
tapinarof cream, 1%, applied topically once daily
tapinarof cream, 1%: applied topically once daily
|
Vehicle Cream
n=137 Participants
vehicle cream, applied topically once daily
Vehicle cream: applied topically once daily
|
|---|---|---|
|
Percent of Subjects With ≥ 75% Improvement in Eczema Area and Severity Index (EASI) From Baseline to Week 8. Analyses Were Done Using Multiple Imputation.
|
55.8 Percentage of participants
|
22.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: ITT Population (MI Estimand)
Assessment of percent body surface area (%BSA) is an estimate of the percentage of total involved skin with atopic dermatitis. Estimates were made using the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumbs together) represented approximately 1% of the total BSA. Body regions are assigned a specific number of handprints with associated percentages (Head and neck = 10% \[10 handprints\], upper extremities = 20% \[20 handprints\], trunk (including axillae and groin) = 30% \[30 handprints\], lower extremities, including buttocks, = 40% \[40 handprints\]). Estimates of the percent involvement of each body region will be multiplied by the fraction of total body area to obtain the total %BSA involved by region and overall.
Outcome measures
| Measure |
Tapinarof Cream
n=270 Participants
tapinarof cream, 1%, applied topically once daily
tapinarof cream, 1%: applied topically once daily
|
Vehicle Cream
n=137 Participants
vehicle cream, applied topically once daily
Vehicle cream: applied topically once daily
|
|---|---|---|
|
Mean Change in in Percent of Total Body Surface Area (%BSA) Affected From Baseline to Week 8.
|
-10.11 change in affected BSA percentage
Standard Error 0.527
|
-4.47 change in affected BSA percentage
Standard Error 0.654
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: ITT Population (MI Estimand)
The Eczema Area and Severity Index (EASI) is a scoring system that takes into account the overall severity of disease based on lesion severity and the extent of percent body surface area affected with atopic dermatitis. The EASI is a composite score ranging from 0 -72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the percent body surface area involved for each body region relative to the whole body. A higher EASI score represents more severe disease. Statistics are based on 100 imputed datasets.
Outcome measures
| Measure |
Tapinarof Cream
n=270 Participants
tapinarof cream, 1%, applied topically once daily
tapinarof cream, 1%: applied topically once daily
|
Vehicle Cream
n=137 Participants
vehicle cream, applied topically once daily
Vehicle cream: applied topically once daily
|
|---|---|---|
|
Percent of Subjects With ≥ 90% Improvement in Eczema Area and Severity Index (EASI) From Baseline to Week 8. Analyses Were Done Using Multiple Imputation.
|
29.8 Percentage of participants
|
6.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: ITT Population (MI Estimand) - subjects ≥ 12 years old with a Baseline PP-NRS score ≥ 4
The Peak Pruritus Numeric Rating Scale (PP-NRS) is used to quickly assess itch/pruritus severity over a 24-hour period. The PP-NRS is scored on a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable". The subject will utilize the scale to assess peak pruritis once per day and record the results in their diaries. The daily ratings are averaged to generate a score for the week. Statistics are based on 100 imputed datasets.
Outcome measures
| Measure |
Tapinarof Cream
n=103 Participants
tapinarof cream, 1%, applied topically once daily
tapinarof cream, 1%: applied topically once daily
|
Vehicle Cream
n=54 Participants
vehicle cream, applied topically once daily
Vehicle cream: applied topically once daily
|
|---|---|---|
|
Percent of Subjects ≥ 12 Years Old With a Baseline Peak Pruritis-Numeric Rating Scale (PP-NRS) Score ≥ 4 Who Achieve ≥ 4-point Reduction in the Average Weekly PP-NRS From Baseline to Week 8.
|
55.8 Percentage of participants
|
34.2 Percentage of participants
|
Adverse Events
Tapinarof Cream
Vehicle Cream
Serious adverse events
| Measure |
Tapinarof Cream
n=270 participants at risk
tapinarof cream, 1%, applied topically once daily
tapinarof cream, 1%: applied topically once daily
|
Vehicle Cream
n=137 participants at risk
vehicle cream, applied topically once daily
Vehicle cream: applied topically once daily
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.37%
1/270 • Number of events 1 • Through study completion, up to 9 weeks
|
0.00%
0/137 • Through study completion, up to 9 weeks
|
|
Immune system disorders
Anaphylactic Shock
|
0.37%
1/270 • Number of events 1 • Through study completion, up to 9 weeks
|
0.00%
0/137 • Through study completion, up to 9 weeks
|
|
Infections and infestations
Arthritis bacterial
|
0.37%
1/270 • Number of events 1 • Through study completion, up to 9 weeks
|
0.00%
0/137 • Through study completion, up to 9 weeks
|
Other adverse events
| Measure |
Tapinarof Cream
n=270 participants at risk
tapinarof cream, 1%, applied topically once daily
tapinarof cream, 1%: applied topically once daily
|
Vehicle Cream
n=137 participants at risk
vehicle cream, applied topically once daily
Vehicle cream: applied topically once daily
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
3.7%
10/270 • Number of events 15 • Through study completion, up to 9 weeks
|
0.73%
1/137 • Number of events 1 • Through study completion, up to 9 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
4/270 • Number of events 4 • Through study completion, up to 9 weeks
|
0.00%
0/137 • Through study completion, up to 9 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
3/270 • Number of events 3 • Through study completion, up to 9 weeks
|
0.73%
1/137 • Number of events 1 • Through study completion, up to 9 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.37%
1/270 • Number of events 1 • Through study completion, up to 9 weeks
|
1.5%
2/137 • Number of events 2 • Through study completion, up to 9 weeks
|
|
General disorders
Pyrexia
|
1.9%
5/270 • Number of events 5 • Through study completion, up to 9 weeks
|
2.2%
3/137 • Number of events 3 • Through study completion, up to 9 weeks
|
|
General disorders
Application site pain
|
1.1%
3/270 • Number of events 4 • Through study completion, up to 9 weeks
|
0.00%
0/137 • Through study completion, up to 9 weeks
|
|
Infections and infestations
Folliculitis
|
8.1%
22/270 • Number of events 22 • Through study completion, up to 9 weeks
|
0.73%
1/137 • Number of events 1 • Through study completion, up to 9 weeks
|
|
Infections and infestations
Nasopharyngitis
|
4.8%
13/270 • Number of events 13 • Through study completion, up to 9 weeks
|
5.1%
7/137 • Number of events 7 • Through study completion, up to 9 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
4.8%
13/270 • Number of events 13 • Through study completion, up to 9 weeks
|
0.00%
0/137 • Through study completion, up to 9 weeks
|
|
Infections and infestations
COVID-19
|
2.6%
7/270 • Number of events 7 • Through study completion, up to 9 weeks
|
3.6%
5/137 • Number of events 5 • Through study completion, up to 9 weeks
|
|
Infections and infestations
Influenza
|
2.2%
6/270 • Number of events 6 • Through study completion, up to 9 weeks
|
0.73%
1/137 • Number of events 1 • Through study completion, up to 9 weeks
|
|
Infections and infestations
Application site folliculitis
|
1.1%
3/270 • Number of events 3 • Through study completion, up to 9 weeks
|
0.00%
0/137 • Through study completion, up to 9 weeks
|
|
Infections and infestations
Gastroenteritis viral
|
1.1%
3/270 • Number of events 3 • Through study completion, up to 9 weeks
|
0.00%
0/137 • Through study completion, up to 9 weeks
|
|
Infections and infestations
Pharyngitis streptococcal
|
1.1%
3/270 • Number of events 3 • Through study completion, up to 9 weeks
|
0.00%
0/137 • Through study completion, up to 9 weeks
|
|
Infections and infestations
Sinusitis
|
1.1%
3/270 • Number of events 3 • Through study completion, up to 9 weeks
|
0.00%
0/137 • Through study completion, up to 9 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.5%
4/270 • Number of events 5 • Through study completion, up to 9 weeks
|
0.00%
0/137 • Through study completion, up to 9 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.1%
3/270 • Number of events 3 • Through study completion, up to 9 weeks
|
0.00%
0/137 • Through study completion, up to 9 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skim papilloma
|
1.1%
3/270 • Number of events 3 • Through study completion, up to 9 weeks
|
0.00%
0/137 • Through study completion, up to 9 weeks
|
|
Nervous system disorders
Headache
|
7.0%
19/270 • Number of events 20 • Through study completion, up to 9 weeks
|
2.2%
3/137 • Number of events 3 • Through study completion, up to 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.2%
6/270 • Number of events 6 • Through study completion, up to 9 weeks
|
0.73%
1/137 • Number of events 1 • Through study completion, up to 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.5%
4/270 • Number of events 4 • Through study completion, up to 9 weeks
|
0.73%
1/137 • Number of events 1 • Through study completion, up to 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.1%
3/270 • Number of events 3 • Through study completion, up to 9 weeks
|
0.00%
0/137 • Through study completion, up to 9 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.5%
4/270 • Number of events 4 • Through study completion, up to 9 weeks
|
2.2%
3/137 • Number of events 3 • Through study completion, up to 9 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.5%
4/270 • Number of events 4 • Through study completion, up to 9 weeks
|
1.5%
2/137 • Number of events 2 • Through study completion, up to 9 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.1%
3/270 • Number of events 3 • Through study completion, up to 9 weeks
|
0.00%
0/137 • Through study completion, up to 9 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.37%
1/270 • Number of events 1 • Through study completion, up to 9 weeks
|
2.2%
3/137 • Number of events 3 • Through study completion, up to 9 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