Trial Outcomes & Findings for Maximal Use Study of Tapinarof Cream, 1% in Pediatric Subjects With Extensive Atopic Dermatitis (NCT NCT05186805)
NCT ID: NCT05186805
Last Updated: 2025-09-05
Results Overview
Number of Participants that Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs).
COMPLETED
PHASE2
36 participants
Baseline to Day 28 for subjects enrolling in Long-Term Extension (LTE), otherwise to Day 35
2025-09-05
Participant Flow
Participants from the DMVT-505-2104 study had the option to participate in the open label extension study (DMVT-505-3103, NCT05142774).
Participant milestones
| Measure |
Tapinarof Cream
Tapinarof (DMVT-505) cream, 1% applied topically once daily
Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Maximal Use Study of Tapinarof Cream, 1% in Pediatric Subjects With Extensive Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Tapinarof Cream
n=36 Participants
Tapinarof (DMVT-505) cream, 1% applied topically once daily
Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
|
|---|---|
|
Age, Categorical
<=18 years
|
36 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
8.9 years
STANDARD_DEVIATION 4.85 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 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
|
3 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
|
6 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
|
0 Participants
n=5 Participants
|
|
Validated Investigator Global Assessment for Atopic Dermatitis
0 - Clear
|
0 Participants
n=5 Participants
|
|
Validated Investigator Global Assessment for Atopic Dermatitis
1 - Almost Clear
|
0 Participants
n=5 Participants
|
|
Validated Investigator Global Assessment for Atopic Dermatitis
2 - Mild
|
0 Participants
n=5 Participants
|
|
Validated Investigator Global Assessment for Atopic Dermatitis
3 - Moderate
|
28 Participants
n=5 Participants
|
|
Validated Investigator Global Assessment for Atopic Dermatitis
4 - Severe
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 28 for subjects enrolling in Long-Term Extension (LTE), otherwise to Day 35Population: Safety population
Number of Participants that Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs).
Outcome measures
| Measure |
Tapinarof Cream
n=36 Participants
Tapinarof (DMVT-505) cream, 1% applied topically once daily
Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
|
|---|---|
|
Number of Participants That Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs)
Experienced an AE
|
8 Participants
|
|
Number of Participants That Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs)
Experienced an SAE
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 28Population: Safety Population, Observed Cases
Change in laboratory values was assessed for clinical relevance
Outcome measures
| Measure |
Tapinarof Cream
n=36 Participants
Tapinarof (DMVT-505) cream, 1% applied topically once daily
Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
|
|---|---|
|
Change From Baseline in Laboratory Values (U/L)
Alanine aminotransferase (U/L)
|
1.9 U/L
Standard Deviation 10.80
|
|
Change From Baseline in Laboratory Values (U/L)
Alkaline phosphatase (U/L)
|
0.7 U/L
Standard Deviation 52.95
|
|
Change From Baseline in Laboratory Values (U/L)
Aspartate aminotransferase (U/L)
|
0.6 U/L
Standard Deviation 6.44
|
PRIMARY outcome
Timeframe: Baseline to Day 28Population: Safety Population, Observed Cases
Change in laboratory values was assessed for clinical relevance
Outcome measures
| Measure |
Tapinarof Cream
n=36 Participants
Tapinarof (DMVT-505) cream, 1% applied topically once daily
Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
|
|---|---|
|
Change From Baseline in Laboratory Values (g/L)
Albumin (g/L)
|
-0.7 g/L
Standard Deviation 2.72
|
|
Change From Baseline in Laboratory Values (g/L)
Protein (g/L)
|
-0.5 g/L
Standard Deviation 4.20
|
|
Change From Baseline in Laboratory Values (g/L)
Ery. mean corpuscular HGB Concentration (g/L)
|
-1.7 g/L
Standard Deviation 7.68
|
|
Change From Baseline in Laboratory Values (g/L)
Hemoglobin (g/L)
|
0.0 g/L
Standard Deviation 7.61
|
PRIMARY outcome
Timeframe: Baseline to Day 28Population: Safety Population, Observed Cases
Change in laboratory values was assessed for clinical relevance
Outcome measures
| Measure |
Tapinarof Cream
n=36 Participants
Tapinarof (DMVT-505) cream, 1% applied topically once daily
Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
|
|---|---|
|
Change From Baseline in Laboratory Values (mmol/L)
Bicarbonate (mmol/L)
|
-0.3 mmol/L
Standard Deviation 2.16
|
|
Change From Baseline in Laboratory Values (mmol/L)
Calcium (mmol/L)
|
-0.006 mmol/L
Standard Deviation 0.0846
|
|
Change From Baseline in Laboratory Values (mmol/L)
Chloride (mmol/L)
|
0.0 mmol/L
Standard Deviation 2.99
|
|
Change From Baseline in Laboratory Values (mmol/L)
Glucose (mmol/L)
|
0.20 mmol/L
Standard Deviation 0.819
|
|
Change From Baseline in Laboratory Values (mmol/L)
Potassium (mmol/L)
|
0.08 mmol/L
Standard Deviation 0.532
|
|
Change From Baseline in Laboratory Values (mmol/L)
Sodium (mmol/L)
|
0.1 mmol/L
Standard Deviation 1.98
|
|
Change From Baseline in Laboratory Values (mmol/L)
Blood urea nitrogen (mmol/L)
|
-0.06 mmol/L
Standard Deviation 0.989
|
PRIMARY outcome
Timeframe: Baseline to Day 28Population: Safety Population, Observed Cases
Change in laboratory values was assessed for clinical relevance
Outcome measures
| Measure |
Tapinarof Cream
n=36 Participants
Tapinarof (DMVT-505) cream, 1% applied topically once daily
Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
|
|---|---|
|
Change From Baseline in Laboratory Values (Umol/L)
Bilirubin (umol/L)
|
-0.34 Umol/L
Standard Deviation 3.700
|
|
Change From Baseline in Laboratory Values (Umol/L)
Enzymatic Creatinine (umol/L)
|
-0.9 Umol/L
Standard Deviation 7.66
|
|
Change From Baseline in Laboratory Values (Umol/L)
Urate (umol/L)
|
-6.0 Umol/L
Standard Deviation 52.16
|
PRIMARY outcome
Timeframe: Baseline to Day 28Population: Safety Population, Observed Cases
Change in laboratory values was assessed for clinical relevance
Outcome measures
| Measure |
Tapinarof Cream
n=36 Participants
Tapinarof (DMVT-505) cream, 1% applied topically once daily
Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
|
|---|---|
|
Change From Baseline in Laboratory Values (10^9 Cells/L)
Basophils (10^9/L)
|
0.01 10^9 cells/L
Standard Deviation 0.048
|
|
Change From Baseline in Laboratory Values (10^9 Cells/L)
Eosinophils (10^9/L)
|
0.00 10^9 cells/L
Standard Deviation 0.419
|
|
Change From Baseline in Laboratory Values (10^9 Cells/L)
Leukocytes (10^9/L)
|
0.71 10^9 cells/L
Standard Deviation 2.451
|
|
Change From Baseline in Laboratory Values (10^9 Cells/L)
Lymphocytes (10^9/L)
|
0.38 10^9 cells/L
Standard Deviation 1.095
|
|
Change From Baseline in Laboratory Values (10^9 Cells/L)
Monocytes (10^9/L)
|
-0.06 10^9 cells/L
Standard Deviation 0.175
|
|
Change From Baseline in Laboratory Values (10^9 Cells/L)
Neutrophils (10^9/L)
|
0.36 10^9 cells/L
Standard Deviation 2.124
|
|
Change From Baseline in Laboratory Values (10^9 Cells/L)
Platelets (10^9/L)
|
-34.8 10^9 cells/L
Standard Deviation 95.27
|
PRIMARY outcome
Timeframe: Baseline to Day 28Population: Safety Population, Observed Cases
Change in laboratory values was assessed for clinical relevance
Outcome measures
| Measure |
Tapinarof Cream
n=36 Participants
Tapinarof (DMVT-505) cream, 1% applied topically once daily
Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
|
|---|---|
|
Change From Baseline in Laboratory Values (%)
Basophils/Total cells (%)
|
0.05 % of cells
Standard Deviation 0.343
|
|
Change From Baseline in Laboratory Values (%)
Eosinophils/Total cells (%)
|
-0.13 % of cells
Standard Deviation 4.606
|
|
Change From Baseline in Laboratory Values (%)
Lymphocytes/Total cells (%)
|
0.81 % of cells
Standard Deviation 11.023
|
|
Change From Baseline in Laboratory Values (%)
Monocytes/Total cells (%)
|
-0.81 % of cells
Standard Deviation 2.662
|
|
Change From Baseline in Laboratory Values (%)
Neutrophils/Total cells (%)
|
0.08 % of cells
Standard Deviation 12.693
|
|
Change From Baseline in Laboratory Values (%)
Reticulocytes/Erythrocytes (%)
|
0.06 % of cells
Standard Deviation 0.377
|
PRIMARY outcome
Timeframe: Baseline to Day 28Population: Safety Population, Observed Cases
Change in Ery. mean corpuscular hemoglobin laboratory values was assessed for clinical relevance
Outcome measures
| Measure |
Tapinarof Cream
n=30 Participants
Tapinarof (DMVT-505) cream, 1% applied topically once daily
Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
|
|---|---|
|
Change From Baseline in Laboratory Values (pg)
|
0.26 pg
Standard Deviation 0.787
|
PRIMARY outcome
Timeframe: Baseline to Day 28Population: Safety Population, Observed Cases
Change in Ery. mean corpuscular volume laboratory values was assessed for clinical relevance
Outcome measures
| Measure |
Tapinarof Cream
n=30 Participants
Tapinarof (DMVT-505) cream, 1% applied topically once daily
Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
|
|---|---|
|
Change From Baseline in Laboratory Values (fL)
|
1.26 fL
Standard Deviation 1.973
|
PRIMARY outcome
Timeframe: Baseline to Day 28Population: Safety Population, Observed Cases
Change in Erythrocytes laboratory values was assessed for clinical relevance
Outcome measures
| Measure |
Tapinarof Cream
n=30 Participants
Tapinarof (DMVT-505) cream, 1% applied topically once daily
Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
|
|---|---|
|
Change From Baseline in Laboratory Values (10^12 Cells/L)
|
-0.055 10^12 cells/L
Standard Deviation 0.2481
|
PRIMARY outcome
Timeframe: Baseline to Day 28Population: Safety Population, Observed Cases
Change in Hematocrit laboratory values was assessed for clinical relevance
Outcome measures
| Measure |
Tapinarof Cream
n=30 Participants
Tapinarof (DMVT-505) cream, 1% applied topically once daily
Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
|
|---|---|
|
Change From Baseline in Laboratory Values (L/L)
|
0.002 L/L
Standard Deviation 0.0228
|
PRIMARY outcome
Timeframe: Baseline to Day 28Population: Safety Population, Observed Cases
Local Tolerability Scale (LTS) is a clinical tool for assessing the presence and overall degree of irritation at the application sites, according to a 5-point scale. 0 indicates no irritation and 4 indicates Very Severe irritation.
Outcome measures
| Measure |
Tapinarof Cream
n=36 Participants
Tapinarof (DMVT-505) cream, 1% applied topically once daily
Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
|
|---|---|
|
Mean Change in Local Tolerability Scale (LTS)
Baseline
|
0.2 Units on a scale
Standard Deviation 0.68
|
|
Mean Change in Local Tolerability Scale (LTS)
Day 28
|
0.1 Units on a scale
Standard Deviation 0.40
|
PRIMARY outcome
Timeframe: Day 1 (PK samples collected pre-dose and at 1, 3, and 5 hours post-dose)Population: PK population
The AUC in plasma is a pharmacokinetic parameter that describes the overall exposure of the drug.
Outcome measures
| Measure |
Tapinarof Cream
n=34 Participants
Tapinarof (DMVT-505) cream, 1% applied topically once daily
Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
|
|---|---|
|
Tapinarof Plasma PK Parameters on Day 1: AUC0-τ
|
4690 pg*h/mL
Standard Deviation 5600
|
PRIMARY outcome
Timeframe: Day 1 (PK samples collected pre-dose and at 1, 3, and 5 hours post-dose)Population: PK population
The Cmax is a pharmacokinetic parameter that describes the highest concentration of the drug that is achieved after dosing.
Outcome measures
| Measure |
Tapinarof Cream
n=35 Participants
Tapinarof (DMVT-505) cream, 1% applied topically once daily
Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
|
|---|---|
|
Tapinarof Plasma PK Parameters on Day 1: Cmax
|
2440 pg/mL
Standard Deviation 3900
|
PRIMARY outcome
Timeframe: Day 1 (PK samples collected pre-dose and at 1, 3, and 5 hours post-dose)Population: PK population
The tmax is a pharmacokinetic parameter that describes the time point at which the highest concentration of the drug is achieved after dosing.
Outcome measures
| Measure |
Tapinarof Cream
n=34 Participants
Tapinarof (DMVT-505) cream, 1% applied topically once daily
Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
|
|---|---|
|
Tapinarof Plasma PK Parameters on Day 1: Tmax
|
2.37 hour
Standard Deviation 1.19
|
PRIMARY outcome
Timeframe: Day 1 (PK samples collected pre-dose and at 1, 3, and 5 hours post-dose)Population: PK Population
The Cτ is a pharmacokinetic parameter that is the last quantifiable concentration determined directly from individual concentration-time data
Outcome measures
| Measure |
Tapinarof Cream
n=34 Participants
Tapinarof (DMVT-505) cream, 1% applied topically once daily
Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
|
|---|---|
|
Tapinarof Plasma Concentration: Cτ
|
1330 pg/mL
Standard Deviation 3780
|
PRIMARY outcome
Timeframe: Baseline to Day 28Population: Safety Population, Observed Cases
Change in pulse vital signs was assessed for clinical relevance
Outcome measures
| Measure |
Tapinarof Cream
n=36 Participants
Tapinarof (DMVT-505) cream, 1% applied topically once daily
Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
|
|---|---|
|
Change From Baseline in Vital Signs (Beats/Min)
|
0.9 Beats/Min
Standard Deviation 14.40
|
PRIMARY outcome
Timeframe: Baseline to Day 28Population: Safety Population, Observed Cases
Change in Blood Pressure vital signs was assessed for clinical relevance
Outcome measures
| Measure |
Tapinarof Cream
n=32 Participants
Tapinarof (DMVT-505) cream, 1% applied topically once daily
Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
|
|---|---|
|
Change From Baseline in Vital Signs (mmHg)
Systolic Blood Pressure (mmHg)
|
1.1 mmHg
Standard Deviation 8.78
|
|
Change From Baseline in Vital Signs (mmHg)
Diastolic Blood Pressure (mmHg)
|
-0.9 mmHg
Standard Deviation 6.63
|
PRIMARY outcome
Timeframe: Baseline to Day 28Population: Safety Population, Observed Cases
Change in Temperature vital signs was assessed for clinical relevance
Outcome measures
| Measure |
Tapinarof Cream
n=32 Participants
Tapinarof (DMVT-505) cream, 1% applied topically once daily
Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
|
|---|---|
|
Change From Baseline in Vital Signs (C)
|
-0.08 degrees C
Standard Deviation 0.402
|
SECONDARY outcome
Timeframe: Baseline to Day 28Population: Safety population, Observed Cases
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.
Outcome measures
| Measure |
Tapinarof Cream
n=32 Participants
Tapinarof (DMVT-505) cream, 1% applied topically once daily
Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
|
|---|---|
|
Change From Baseline in Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD)
+4 = worsened by 4
|
0 Participants
|
|
Change From Baseline in Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD)
+3 = worsened by 3
|
0 Participants
|
|
Change From Baseline in Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD)
+2 = worsened by 2
|
0 Participants
|
|
Change From Baseline in Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD)
+1 = worsened by 1
|
0 Participants
|
|
Change From Baseline in Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD)
0 - no change
|
8 Participants
|
|
Change From Baseline in Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD)
-1 = improved by 1
|
14 Participants
|
|
Change From Baseline in Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD)
-2 = improved by 2
|
8 Participants
|
|
Change From Baseline in Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD)
-3 = improved by 3
|
2 Participants
|
|
Change From Baseline in Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD)
-4 = improved by 4
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 28Population: Safety Population, Observed Cases
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.
Outcome measures
| Measure |
Tapinarof Cream
n=32 Participants
Tapinarof (DMVT-505) cream, 1% applied topically once daily
Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
|
|---|---|
|
Number of Subjects Who Have a Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD) Score of Almost Clear (0 or 1) and at Least a 2-grade Reduction From Baseline
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 28Population: Safety Population, Observed Cases
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.
Outcome measures
| Measure |
Tapinarof Cream
n=32 Participants
Tapinarof (DMVT-505) cream, 1% applied topically once daily
Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
|
|---|---|
|
Number of Subjects With ≥50%, Improvement in Eczema Area and Severity Index (EASI) Score
|
20 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 28Population: Safety Population, Observed Cases
The EASI is a composite score ranging from 0 to 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 %BSA involved for each body region relative to the whole body. Higher EASI scores indicate more severe disease.
Outcome measures
| Measure |
Tapinarof Cream
n=32 Participants
Tapinarof (DMVT-505) cream, 1% applied topically once daily
Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
|
|---|---|
|
Number of Subjects With ≥75%, Improvement in Eczema Area and Severity Index (EASI) Score
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 28Population: Safety Population, Observed Cases
The EASI is a composite score ranging from 0 to 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 %BSA involved for each body region relative to the whole body. Higher EASI scores indicate more severe disease.
Outcome measures
| Measure |
Tapinarof Cream
n=32 Participants
Tapinarof (DMVT-505) cream, 1% applied topically once daily
Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
|
|---|---|
|
Number of Subjects With ≥90%, Improvement in Eczema Area and Severity Index (EASI) Score
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 28Population: Safety Population, Observed cases
The EASI is a composite score ranging from 0 to 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 %BSA involved for each body region relative to the whole body. Higher EASI scores indicate more severe disease.
Outcome measures
| Measure |
Tapinarof Cream
n=32 Participants
Tapinarof (DMVT-505) cream, 1% applied topically once daily
Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
|
|---|---|
|
Mean Change in Eczema Area and Severity Index EASI From Baseline to Day 28
|
-12.16 scores on a scale
Standard Deviation 9.742
|
SECONDARY outcome
Timeframe: Baseline to Day 28Population: Safety Population, Observed cases
The EASI is a composite score ranging from 0 to 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 %BSA involved for each body region relative to the whole body. Higher EASI scores indicate more severe disease.
Outcome measures
| Measure |
Tapinarof Cream
n=32 Participants
Tapinarof (DMVT-505) cream, 1% applied topically once daily
Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
|
|---|---|
|
Percent Change in Eczema Area and Severity Index EASI From Baseline to Day 28
|
-53.38 % change from baseline
Standard Deviation 38.337
|
SECONDARY outcome
Timeframe: Baseline to Day 28Population: Safety Population, Observed cases
The assessment of %BSA affected is an estimate of the percentage of total involved skin with psoriasis. For the purpose of clinical estimation, the total palmar surface of the subject's palm and digits may be assumed to be approximately equivalent to 1% BSA. The %BSA affected by psoriasis will be evaluated (from 0% to 100%). %BSA is a static assessment made without reference to previous scores.
Outcome measures
| Measure |
Tapinarof Cream
n=32 Participants
Tapinarof (DMVT-505) cream, 1% applied topically once daily
Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
|
|---|---|
|
Mean Change in Percent of Total Body Surface Area (%BSA) Affected
|
-21.06 percentage of BSA
Standard Deviation 18.789
|
SECONDARY outcome
Timeframe: Baseline to Day 28Population: Safety Population, Observed cases
The assessment of %BSA affected is an estimate of the percentage of total involved skin with psoriasis. For the purpose of clinical estimation, the total palmar surface of the subject's palm and digits may be assumed to be approximately equivalent to 1% BSA. The %BSA affected by psoriasis will be evaluated (from 0% to 100%). %BSA is a static assessment made without reference to previous scores.
Outcome measures
| Measure |
Tapinarof Cream
n=32 Participants
Tapinarof (DMVT-505) cream, 1% applied topically once daily
Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
|
|---|---|
|
Percent Change in Percent of Total Body Surface Area (%BSA) Affected
|
-49.40 % change from baseline
Standard Deviation 41.3000
|
SECONDARY outcome
Timeframe: Baseline to Day 28Population: Safety Population, Observed Cases
The vIGA-AD is a clinical tool for assessing the current state/severity of a subject's atopic dermatitis at a given timepoint. It is a static 5-point morphological assessment of overall disease severity using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting (0 indicates no inflammatory signs of atopic dermatitis and 4 indicates disease is widespread). The assessment of %BSA affected is an estimate of the percentage of total involved skin with psoriasis. For clinical estimation, the total palmar surface of the subject's palm and digits may be assumed to be approximately equivalent to 1% BSA. %BSA is a static assessment made without reference to previous scores and will be evaluated 0-100%. The computation is referenced below, and no unit is applicable for this outcome measure. A negative change indicates improvement in disease. \[Total Body Surface Area (BSA) x Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD)\]
Outcome measures
| Measure |
Tapinarof Cream
n=32 Participants
Tapinarof (DMVT-505) cream, 1% applied topically once daily
Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
|
|---|---|
|
Mean Change in Total Body Surface Area (BSA) x Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD) Values
|
-85.15 unitless
Standard Deviation 65.848
|
SECONDARY outcome
Timeframe: Baseline to Day 28Population: Safety Population, Observed Cases
The vIGA-AD is a clinical tool for assessing the current state/severity of a subject's atopic dermatitis at a given timepoint. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. Score of 0 indicates no inflammatory signs of atopic dermatitis and a 4 indicates disease is widespread in extent. The assessment of %BSA affected is an estimate of the percentage of total involved skin with psoriasis. For the purpose of clinical estimation, the total palmar surface of the subject's palm and digits may be assumed to be approximately equivalent to 1% BSA. The %BSA affected by psoriasis will be evaluated (from 0% to 100%). %BSA is a static assessment made without reference to previous scores. Computation: Total Body Surface Area (BSA) x Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD)
Outcome measures
| Measure |
Tapinarof Cream
n=32 Participants
Tapinarof (DMVT-505) cream, 1% applied topically once daily
Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
|
|---|---|
|
Percent Change in Total Body Surface Area (BSA) x Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD) Values
|
-62.77 % change from baseline
Standard Deviation 35.290
|
SECONDARY outcome
Timeframe: Baseline to Day 28Population: Safety Population, Observed Cases
The PP-NRS is a scale from 0-10 used to assess itch/pruritus severity over a 24-hour period which will be used daily to assess peak pruritus. Higher PP-NRS ratings represent more itch reported.
Outcome measures
| Measure |
Tapinarof Cream
n=33 Participants
Tapinarof (DMVT-505) cream, 1% applied topically once daily
Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
|
|---|---|
|
Mean Change in Average Weekly Peak Pruritus Numerical Rating Scale (PP-NRS) Score
|
-4.155 Units on a scale
Standard Deviation 2.4558
|
SECONDARY outcome
Timeframe: Baseline to Day 28Population: Safety Population, Observed cases, subjects with baseline PP-NRS score ≥4
The PP-NRS is a scale from 0-10 used to assess itch/pruritus severity over a 24-hour period which will be used daily to assess peak pruritus. Higher PP-NRS ratings represent more itch reported.
Outcome measures
| Measure |
Tapinarof Cream
n=32 Participants
Tapinarof (DMVT-505) cream, 1% applied topically once daily
Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
|
|---|---|
|
Proportion of Subjects With a Baseline Peak Pruritus Numerical Rating Scale (PP-NRS) Score ≥4 Who Achieved ≥4-point Reduction in PP-NRS Score
Achieved ≥ 4-Point Reduction from Baseline in the Average Weekly PP-NRS Score
|
14 Participants
|
|
Proportion of Subjects With a Baseline Peak Pruritus Numerical Rating Scale (PP-NRS) Score ≥4 Who Achieved ≥4-point Reduction in PP-NRS Score
Failure to Achieve a ≥ 4-point Reduction from Baseline in the Average Weekly PP-NRS Score
|
18 Participants
|
Adverse Events
Tapinarof Cream
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tapinarof Cream
n=36 participants at risk
Tapinarof (DMVT-505) cream, 1% applied topically once daily
Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
|
|---|---|
|
Nervous system disorders
Headache
|
8.3%
3/36 • Number of events 4 • Baseline to Day 28 for subjects enrolling in Long-Term Extension (LTE), otherwise to Day 35
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
2/36 • Number of events 2 • Baseline to Day 28 for subjects enrolling in Long-Term Extension (LTE), otherwise to Day 35
|
|
Gastrointestinal disorders
Nausea
|
2.8%
1/36 • Number of events 1 • Baseline to Day 28 for subjects enrolling in Long-Term Extension (LTE), otherwise to Day 35
|
|
Infections and infestations
Folliculitis
|
2.8%
1/36 • Number of events 1 • Baseline to Day 28 for subjects enrolling in Long-Term Extension (LTE), otherwise to Day 35
|
|
Infections and infestations
Influenza
|
2.8%
1/36 • Number of events 1 • Baseline to Day 28 for subjects enrolling in Long-Term Extension (LTE), otherwise to Day 35
|
|
Infections and infestations
Pustule
|
2.8%
1/36 • Number of events 1 • Baseline to Day 28 for subjects enrolling in Long-Term Extension (LTE), otherwise to Day 35
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
2.8%
1/36 • Number of events 1 • Baseline to Day 28 for subjects enrolling in Long-Term Extension (LTE), otherwise to Day 35
|
|
Investigations
Tranaminases increased
|
2.8%
1/36 • Number of events 1 • Baseline to Day 28 for subjects enrolling in Long-Term Extension (LTE), otherwise to Day 35
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.8%
1/36 • Number of events 1 • Baseline to Day 28 for subjects enrolling in Long-Term Extension (LTE), otherwise to Day 35
|
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