Trial Outcomes & Findings for Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults (DMVT-505-3102) (NCT NCT05032859)
NCT ID: NCT05032859
Last Updated: 2025-09-02
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
406 participants
Baseline to Week 8
2025-09-02
Participant Flow
Participants from the main study (DMVT-505-3102) 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
|
Vehicle Cream
vehicle cream, applied topically once daily
|
|---|---|---|
|
Overall Study
STARTED
|
271
|
135
|
|
Overall Study
COMPLETED
|
235
|
106
|
|
Overall Study
NOT COMPLETED
|
36
|
29
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults (DMVT-505-3102)
Baseline characteristics by cohort
| Measure |
Tapinarof Cream
n=271 Participants
tapinarof cream, 1%, applied topically once daily
|
Vehicle Cream
n=135 Participants
vehicle cream, applied topically once daily
|
Total
n=406 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
16.4 years
STANDARD_DEVIATION 16.24 • n=5 Participants
|
16.7 years
STANDARD_DEVIATION 16.05 • n=7 Participants
|
16.5 years
STANDARD_DEVIATION 16.16 • n=5 Participants
|
|
Age, Customized
2-6 Years
|
65 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Age, Customized
7-11 Years
|
64 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Age, Customized
12-17 Years
|
89 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Age, Customized
≥18 Years
|
53 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
154 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
231 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
117 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
49 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
221 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
328 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
39 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
95 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
124 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
41 Count of participants
n=5 Participants
|
22 Count of participants
n=7 Participants
|
63 Count of participants
n=5 Participants
|
|
Region of Enrollment
United States
|
230 Count of participants
n=5 Participants
|
113 Count of participants
n=7 Participants
|
343 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
|
228 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
341 Participants
n=5 Participants
|
|
Validated Investigator Global Assessment for Atopic Dermatitis
4 - Severe
|
43 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Percent Body Surface Area (BSA)
|
17.13 Percentage of Affected BSA
STANDARD_DEVIATION 8.743 • n=5 Participants
|
15.84 Percentage of Affected BSA
STANDARD_DEVIATION 7.888 • n=7 Participants
|
16.70 Percentage of Affected BSA
STANDARD_DEVIATION 8.480 • n=5 Participants
|
|
Eczema Area and Severity Index (EASI)
|
13.45 units on a scale
STANDARD_DEVIATION 5.615 • n=5 Participants
|
13.09 units on a scale
STANDARD_DEVIATION 4.689 • n=7 Participants
|
13.33 units on a scale
STANDARD_DEVIATION 5.322 • 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=271 Participants
tapinarof cream, 1%, applied topically once daily
|
Vehicle Cream
n=135 Participants
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.
|
46.4 Percentage of participants
|
18.0 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=271 Participants
tapinarof cream, 1%, applied topically once daily
|
Vehicle Cream
n=135 Participants
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.
|
59.1 Percentage of participants
|
21.2 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=271 Participants
tapinarof cream, 1%, applied topically once daily
|
Vehicle Cream
n=135 Participants
vehicle cream, applied topically once daily
|
|---|---|---|
|
Mean Change in in Percent of Total Body Surface Area (%BSA) Affected From Baseline to Week 8.
|
-10.36 Change in affected BSA percentage
Standard Error 0.540
|
-3.14 Change in affected BSA percentage
Standard Error 0.676
|
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=271 Participants
tapinarof cream, 1%, applied topically once daily
|
Vehicle Cream
n=135 Participants
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.
|
30.1 Percentage of participants
|
10.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: ITT Population (MI Estimand)
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=271 Participants
tapinarof cream, 1%, applied topically once daily
|
Vehicle Cream
n=135 Participants
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.
|
52.8 Percentage of participants
|
24.1 Percentage of participants
|
Adverse Events
Tapinarof Cream
Vehicle Cream
Serious adverse events
| Measure |
Tapinarof Cream
n=271 participants at risk
tapinarof cream, 1%, applied topically once daily
|
Vehicle Cream
n=133 participants at risk
vehicle cream, applied topically once daily
|
|---|---|---|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.37%
1/271 • Number of events 1 • Through study completion, up to 9 weeks
|
0.00%
0/133 • Through study completion, up to 9 weeks
|
|
Nervous system disorders
Psychogenic seizure
|
0.37%
1/271 • Number of events 1 • Through study completion, up to 9 weeks
|
0.00%
0/133 • Through study completion, up to 9 weeks
|
Other adverse events
| Measure |
Tapinarof Cream
n=271 participants at risk
tapinarof cream, 1%, applied topically once daily
|
Vehicle Cream
n=133 participants at risk
vehicle cream, applied topically once daily
|
|---|---|---|
|
Gastrointestinal disorders
Pyrexia
|
1.5%
4/271 • Number of events 4 • Through study completion, up to 9 weeks
|
1.5%
2/133 • Number of events 2 • Through study completion, up to 9 weeks
|
|
Infections and infestations
Folliculitis
|
8.1%
22/271 • Number of events 23 • Through study completion, up to 9 weeks
|
1.5%
2/133 • Number of events 2 • Through study completion, up to 9 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
3.0%
8/271 • Number of events 9 • Through study completion, up to 9 weeks
|
1.5%
2/133 • Number of events 2 • Through study completion, up to 9 weeks
|
|
Infections and infestations
COVID-19
|
2.2%
6/271 • Number of events 6 • Through study completion, up to 9 weeks
|
0.00%
0/133 • Through study completion, up to 9 weeks
|
|
Infections and infestations
Nasopharyngitis
|
1.5%
4/271 • Number of events 4 • Through study completion, up to 9 weeks
|
0.75%
1/133 • Number of events 3 • Through study completion, up to 9 weeks
|
|
Infections and infestations
Ear infection
|
1.1%
3/271 • Number of events 3 • Through study completion, up to 9 weeks
|
0.00%
0/133 • Through study completion, up to 9 weeks
|
|
Nervous system disorders
Headache
|
1.5%
4/271 • Number of events 4 • Through study completion, up to 9 weeks
|
0.00%
0/133 • Through study completion, up to 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.5%
4/271 • Number of events 4 • Through study completion, up to 9 weeks
|
0.00%
0/133 • Through study completion, up to 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.1%
3/271 • Number of events 3 • Through study completion, up to 9 weeks
|
0.75%
1/133 • Number of events 1 • Through study completion, up to 9 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.1%
3/271 • Number of events 3 • Through study completion, up to 9 weeks
|
1.5%
2/133 • Number of events 2 • Through study completion, up to 9 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.37%
1/271 • Number of events 1 • Through study completion, up to 9 weeks
|
1.5%
2/133 • Number of events 2 • Through study completion, up to 9 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/271 • Through study completion, up to 9 weeks
|
1.5%
2/133 • Number of events 2 • 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