| Primary | Number of Participants That Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of Participants that Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs). | | Posted | | Count of Participants | | Participants | | Baseline to Day 28 for subjects enrolling in Long-Term Extension (LTE), otherwise to Day 35 | | | | ID | Title | Description |
|---|
| OG000 | Tapinarof Cream | Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily |
| | | Title | Denominators | Categories |
|---|
| Experienced an AE | | | | Experienced an SAE | | |
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| Primary | Change From Baseline in Laboratory Values (U/L) | Change in laboratory values was assessed for clinical relevance | Safety Population, Observed Cases | Posted | | Mean | Standard Deviation | U/L | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Tapinarof Cream | Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily |
| | |
| Primary | Change From Baseline in Laboratory Values (g/L) | Change in laboratory values was assessed for clinical relevance | Safety Population, Observed Cases | Posted | | Mean | Standard Deviation | g/L | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Tapinarof Cream | Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily |
| | |
| Primary | Change From Baseline in Laboratory Values (mmol/L) | Change in laboratory values was assessed for clinical relevance | Safety Population, Observed Cases | Posted | | Mean | Standard Deviation | mmol/L | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Tapinarof Cream | Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily |
| | |
| Primary | Change From Baseline in Laboratory Values (Umol/L) | Change in laboratory values was assessed for clinical relevance | Safety Population, Observed Cases | Posted | | Mean | Standard Deviation | Umol/L | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Tapinarof Cream | Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily |
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| Primary | Change From Baseline in Laboratory Values (10^9 Cells/L) | Change in laboratory values was assessed for clinical relevance | Safety Population, Observed Cases | Posted | | Mean | Standard Deviation | 10^9 cells/L | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Tapinarof Cream | Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily |
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| Primary | Change From Baseline in Laboratory Values (%) | Change in laboratory values was assessed for clinical relevance | Safety Population, Observed Cases | Posted | | Mean | Standard Deviation | % of cells | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Tapinarof Cream | Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily |
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| Primary | Change From Baseline in Laboratory Values (pg) | Change in Ery. mean corpuscular hemoglobin laboratory values was assessed for clinical relevance | Safety Population, Observed Cases | Posted | | Mean | Standard Deviation | pg | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Tapinarof Cream | Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily |
| | |
| Primary | Change From Baseline in Laboratory Values (fL) | Change in Ery. mean corpuscular volume laboratory values was assessed for clinical relevance | Safety Population, Observed Cases | Posted | | Mean | Standard Deviation | fL | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Tapinarof Cream | Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily |
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| Primary | Change From Baseline in Laboratory Values (10^12 Cells/L) | Change in Erythrocytes laboratory values was assessed for clinical relevance | Safety Population, Observed Cases | Posted | | Mean | Standard Deviation | 10^12 cells/L | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Tapinarof Cream | Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily |
| | |
| Primary | Change From Baseline in Laboratory Values (L/L) | Change in Hematocrit laboratory values was assessed for clinical relevance | Safety Population, Observed Cases | Posted | | Mean | Standard Deviation | L/L | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Tapinarof Cream | Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily |
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| Primary | Mean Change in Local Tolerability Scale (LTS) | 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. | Safety Population, Observed Cases | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Tapinarof Cream | Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily |
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| Primary | Tapinarof Plasma PK Parameters on Day 1: AUC0-τ | The AUC in plasma is a pharmacokinetic parameter that describes the overall exposure of the drug. | | Posted | | Mean | Standard Deviation | pg*h/mL | | Day 1 (PK samples collected pre-dose and at 1, 3, and 5 hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | Tapinarof Cream | Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily |
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| Primary | Tapinarof Plasma PK Parameters on Day 1: Cmax | The Cmax is a pharmacokinetic parameter that describes the highest concentration of the drug that is achieved after dosing. | | Posted | | Mean | Standard Deviation | pg/mL | | Day 1 (PK samples collected pre-dose and at 1, 3, and 5 hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | Tapinarof Cream | Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily |
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| Primary | Tapinarof Plasma PK Parameters on Day 1: Tmax | The tmax is a pharmacokinetic parameter that describes the time point at which the highest concentration of the drug is achieved after dosing. | | Posted | | Mean | Standard Deviation | hour | | Day 1 (PK samples collected pre-dose and at 1, 3, and 5 hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | Tapinarof Cream | Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily |
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| Primary | Tapinarof Plasma Concentration: Cτ | The Cτ is a pharmacokinetic parameter that is the last quantifiable concentration determined directly from individual concentration-time data | | Posted | | Mean | Standard Deviation | pg/mL | | Day 1 (PK samples collected pre-dose and at 1, 3, and 5 hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | Tapinarof Cream | Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily |
| | |
| Primary | Change From Baseline in Vital Signs (Beats/Min) | Change in pulse vital signs was assessed for clinical relevance | Safety Population, Observed Cases | Posted | | Mean | Standard Deviation | Beats/Min | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Tapinarof Cream | Tapinarof (DMVT-505) cream, 1% applied topically once daily |
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| Primary | Change From Baseline in Vital Signs (mmHg) | Change in Blood Pressure vital signs was assessed for clinical relevance | Safety Population, Observed Cases | Posted | | Mean | Standard Deviation | mmHg | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Tapinarof Cream | Tapinarof (DMVT-505) cream, 1% applied topically once daily |
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| Primary | Change From Baseline in Vital Signs (C) | Change in Temperature vital signs was assessed for clinical relevance | Safety Population, Observed Cases | Posted | | Mean | Standard Deviation | degrees C | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Tapinarof Cream | Tapinarof (DMVT-505) cream, 1% applied topically once daily |
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| Secondary | Change From Baseline in Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD) | 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. | Safety population, Observed Cases | Posted | | Count of Participants | | Participants | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Tapinarof Cream | Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily |
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| Secondary | 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 | 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. | Safety Population, Observed Cases | Posted | | Count of Participants | | Participants | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Tapinarof Cream | Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily |
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| Secondary | Number of Subjects With ≥50%, Improvement in Eczema Area and Severity Index (EASI) Score | 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. | Safety Population, Observed Cases | Posted | | Count of Participants | | Participants | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Tapinarof Cream | Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily |
| |
| Secondary | Number of Subjects With ≥75%, Improvement in Eczema Area and Severity Index (EASI) Score | 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. | Safety Population, Observed Cases | Posted | | Count of Participants | | Participants | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Tapinarof Cream | Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily |
| |
| Secondary | Number of Subjects With ≥90%, Improvement in Eczema Area and Severity Index (EASI) Score | 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. | Safety Population, Observed Cases | Posted | | Count of Participants | | Participants | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Tapinarof Cream | Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily |
| |
| Secondary | Mean Change in Eczema Area and Severity Index EASI From Baseline to Day 28 | 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. | Safety Population, Observed cases | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Tapinarof Cream | Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily |
| |
| Secondary | Percent Change in Eczema Area and Severity Index EASI From Baseline to Day 28 | 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. | Safety Population, Observed cases | Posted | | Mean | Standard Deviation | % change from baseline | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Tapinarof Cream | Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily |
| |
| Secondary | Mean Change in Percent of Total Body Surface Area (%BSA) Affected | 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. | Safety Population, Observed cases | Posted | | Mean | Standard Deviation | percentage of BSA | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Tapinarof Cream | Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily |
| |
| Secondary | Percent Change in Percent of Total Body Surface Area (%BSA) Affected | 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. | Safety Population, Observed cases | Posted | | Mean | Standard Deviation | % change from baseline | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Tapinarof Cream | Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily |
| |
| Secondary | Mean Change in Total Body Surface Area (BSA) x Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD) Values | 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)] | Safety Population, Observed Cases | Posted | | Mean | Standard Deviation | unitless | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Tapinarof Cream | Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily |
| |
| Secondary | Percent Change in Total Body Surface Area (BSA) x Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD) Values | 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) | Safety Population, Observed Cases | Posted | | Mean | Standard Deviation | % change from baseline | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Tapinarof Cream | Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily |
| |
| Secondary | Mean Change in Average Weekly Peak Pruritus Numerical Rating Scale (PP-NRS) Score | 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. | Safety Population, Observed Cases | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Tapinarof Cream | Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily |
| |
| Secondary | Proportion of Subjects With a Baseline Peak Pruritus Numerical Rating Scale (PP-NRS) Score ≥4 Who Achieved ≥4-point Reduction in PP-NRS Score | 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. | Safety Population, Observed cases, subjects with baseline PP-NRS score ≥4 | Posted | | Count of Participants | | Participants | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Tapinarof Cream | Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily |
| |