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CompletedNCT05186805Updated Sep 5, 2025Results posted

Maximal Use Study of Tapinarof Cream, 1% in Pediatric Subjects With Extensive Atopic Dermatitis

A Phase 2 interventional study of Tapinarof cream, 1% in Atopic Dermatitis, sponsored by Organon and Co. Completed at 10 sites in 2 countries. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-09-05.

Sponsored by Organon and Co · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
36
Allocation
Not applicable
Ages
2 Years to 17 Years
Sex
All
01

Study summary

This is an open-label, multicenter study to evaluate the systemic exposure and safety of topical tapinarof cream, 1% under conditions of maximal use in pediatric subjects with atopic dermatitis

Read the detailed description

This is a 4-week open-label study in which subjects will be assigned to receive tapinarof cream, 1% once daily for 4 weeks. At the end of the 4-week study treatment, qualified subjects will have the option to enroll in an open-label, long-term extension study for an additional 48 weeks of treatment. Subjects who do not participate in the open-label, long-term extension study will complete a follow-up visit approximately one week after the end of treatment in this study.

02

Conditions studied

  • Atopic Dermatitis

Keywords

  • eczema
  • pediatric
  • tapinarof
  • phase 2
  • topical
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 36 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.

Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male and female subjects age 2 to 17 with a confirmed clinical diagnosis of atopic dermatitis and present for at least 6 months for ages 6-17 years old, 3 months for ages 2-5 years old
  • BSA involvement ≥ 25% for subjects ages 12-17 years old, or ≥ 35% for subjects ages 2-11 years old, suitable for topical therapy.
  • vIGA-AD score of ≥ 3 at screening and baseline (pre-dose)
  • Female subjects of child bearing potential who are engaging in sexual activity that could lead to pregnancy agree to follow the specified contraceptive guidance throughout the study
  • Capable of giving written informed consent
  • Negative pregnancy test at Baseline (Day 1)

Exclusion criteria

Exclusion Criteria:

  • Immunocompromised at screening
  • Chronic or acute systemic or superficial infection requiring treatment with systemic antibacterials or antifungals within one week prior to baseline visit
  • Significant dermatological or inflammatory condition other than AD that, in the Investigator's opinion, would make it difficult to interpret data or assessments during the study
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.0x the upper limit of normal (ULN).
  • Screening total bilirubin > 1.5x ULN
  • Current or chronic history of liver disease
  • Current or history of cancer within 5 years except for adequately treated cutaneous basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix
  • Subjects who would not be considered suitable for topical therapy
  • Use of any prohibited medication or procedure within the indicated period before the baseline visit including other investigational product within 30 days or 5 half-lives of the investigational product (whichever is longer)
  • History of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the Investigator's opinion, may interfere with the subject's participation in the study, interpretation of results, or ability to understand and give informed consent.
  • Pregnant or lactating females
  • History of sensitivity to the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the -Investigator or Medical Monitor, contraindicates their participation
  • Previous known participation in a clinical study with tapinarof (previously known as GSK2894512 and WBI-1001)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    tapinarof cream

    Tapinarof (DMVT-505) cream, 1% applied topically once daily

    Drug: Tapinarof cream, 1%

Interventions

  • DrugTapinarof cream, 1%

    Tapinarof cream, 1% applied topically once daily

    Also known as: DMVT-505

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Baseline to Day 28 for subjects enrolling in Long-Term Extension (LTE), otherwise to Day 35

  2. Change From Baseline in Laboratory Values (U/L)

    Change in laboratory values was assessed for clinical relevance

    Time frame: Baseline to Day 28

  3. Change From Baseline in Laboratory Values (g/L)

    Change in laboratory values was assessed for clinical relevance

    Time frame: Baseline to Day 28

  4. Change From Baseline in Laboratory Values (mmol/L)

    Change in laboratory values was assessed for clinical relevance

    Time frame: Baseline to Day 28

  5. Change From Baseline in Laboratory Values (Umol/L)

    Change in laboratory values was assessed for clinical relevance

    Time frame: Baseline to Day 28

  6. Change From Baseline in Laboratory Values (10^9 Cells/L)

    Change in laboratory values was assessed for clinical relevance

    Time frame: Baseline to Day 28

  7. Change From Baseline in Laboratory Values (%)

    Change in laboratory values was assessed for clinical relevance

    Time frame: Baseline to Day 28

  8. Change From Baseline in Laboratory Values (pg)

    Change in Ery. mean corpuscular hemoglobin laboratory values was assessed for clinical relevance

    Time frame: Baseline to Day 28

  9. Change From Baseline in Laboratory Values (fL)

    Change in Ery. mean corpuscular volume laboratory values was assessed for clinical relevance

    Time frame: Baseline to Day 28

  10. Change From Baseline in Laboratory Values (10^12 Cells/L)

    Change in Erythrocytes laboratory values was assessed for clinical relevance

    Time frame: Baseline to Day 28

  11. Change From Baseline in Laboratory Values (L/L)

    Change in Hematocrit laboratory values was assessed for clinical relevance

    Time frame: Baseline to Day 28

  12. 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.

    Time frame: Baseline to Day 28

  13. 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.

    Time frame: Day 1 (PK samples collected pre-dose and at 1, 3, and 5 hours post-dose)

  14. 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.

    Time frame: Day 1 (PK samples collected pre-dose and at 1, 3, and 5 hours post-dose)

  15. 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.

    Time frame: Day 1 (PK samples collected pre-dose and at 1, 3, and 5 hours post-dose)

  16. Tapinarof Plasma Concentration: Cτ

    The Cτ is a pharmacokinetic parameter that is the last quantifiable concentration determined directly from individual concentration-time data

    Time frame: Day 1 (PK samples collected pre-dose and at 1, 3, and 5 hours post-dose)

  17. Change From Baseline in Vital Signs (Beats/Min)

    Change in pulse vital signs was assessed for clinical relevance

    Time frame: Baseline to Day 28

  18. Change From Baseline in Vital Signs (mmHg)

    Change in Blood Pressure vital signs was assessed for clinical relevance

    Time frame: Baseline to Day 28

  19. Change From Baseline in Vital Signs (C)

    Change in Temperature vital signs was assessed for clinical relevance

    Time frame: Baseline to Day 28

Secondary outcomes

  1. 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.

    Time frame: Baseline to Day 28

  2. 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.

    Time frame: Baseline to Day 28

  3. 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.

    Time frame: Baseline to Day 28

  4. 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.

    Time frame: Baseline to Day 28

  5. 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.

    Time frame: Baseline to Day 28

  6. 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.

    Time frame: Baseline to Day 28

  7. 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.

    Time frame: Baseline to Day 28

  8. 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.

    Time frame: Baseline to Day 28

  9. 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.

    Time frame: Baseline to Day 28

  10. 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. \[Total Body Surface Area (BSA) x Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD)\]

    Time frame: Baseline to Day 28

  11. 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)

    Time frame: Baseline to Day 28

  12. 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.

    Time frame: Baseline to Day 28

  13. 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.

    Time frame: Baseline to Day 28

07

Results

Posted Sep 5, 2025

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 flow — Overall Study
MilestoneTapinarof Cream
Started36
Completed32
Not completed4

Outcome measures

PrimaryNumber 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).

Time frame:
Baseline to Day 28 for subjects enrolling in Long-Term Extension (LTE), otherwise to Day 35
Reported as:
Count of participants · Participants
Number of Participants That Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs)
ParticipantsTapinarof Cream
Experienced an AE8
Experienced an SAE0
PrimaryChange From Baseline in Laboratory Values (U/L)

Change in laboratory values was assessed for clinical relevance

Time frame:
Baseline to Day 28
Reported as:
Mean · U/L
Change From Baseline in Laboratory Values (U/L)
U/LTapinarof Cream
Alanine aminotransferase (U/L)1.9 ± 10.80
Alkaline phosphatase (U/L)0.7 ± 52.95
Aspartate aminotransferase (U/L)0.6 ± 6.44
PrimaryChange From Baseline in Laboratory Values (g/L)

Change in laboratory values was assessed for clinical relevance

Time frame:
Baseline to Day 28
Reported as:
Mean · g/L
Change From Baseline in Laboratory Values (g/L)
g/LTapinarof Cream
Albumin (g/L)-0.7 ± 2.72
Protein (g/L)-0.5 ± 4.20
Ery. mean corpuscular HGB Concentration (g/L)-1.7 ± 7.68
Hemoglobin (g/L)0.0 ± 7.61
PrimaryChange From Baseline in Laboratory Values (mmol/L)

Change in laboratory values was assessed for clinical relevance

Time frame:
Baseline to Day 28
Reported as:
Mean · mmol/L
Change From Baseline in Laboratory Values (mmol/L)
mmol/LTapinarof Cream
Bicarbonate (mmol/L)-0.3 ± 2.16
Calcium (mmol/L)-0.006 ± 0.0846
Chloride (mmol/L)0.0 ± 2.99
Glucose (mmol/L)0.20 ± 0.819
Potassium (mmol/L)0.08 ± 0.532
Sodium (mmol/L)0.1 ± 1.98
Blood urea nitrogen (mmol/L)-0.06 ± 0.989
PrimaryChange From Baseline in Laboratory Values (Umol/L)

Change in laboratory values was assessed for clinical relevance

Time frame:
Baseline to Day 28
Reported as:
Mean · Umol/L
Change From Baseline in Laboratory Values (Umol/L)
Umol/LTapinarof Cream
Bilirubin (umol/L)-0.34 ± 3.700
Enzymatic Creatinine (umol/L)-0.9 ± 7.66
Urate (umol/L)-6.0 ± 52.16
PrimaryChange From Baseline in Laboratory Values (10^9 Cells/L)

Change in laboratory values was assessed for clinical relevance

Time frame:
Baseline to Day 28
Reported as:
Mean · 10^9 cells/L
Change From Baseline in Laboratory Values (10^9 Cells/L)
10^9 cells/LTapinarof Cream
Basophils (10^9/L)0.01 ± 0.048
Eosinophils (10^9/L)0.00 ± 0.419
Leukocytes (10^9/L)0.71 ± 2.451
Lymphocytes (10^9/L)0.38 ± 1.095
Monocytes (10^9/L)-0.06 ± 0.175
Neutrophils (10^9/L)0.36 ± 2.124
Platelets (10^9/L)-34.8 ± 95.27
PrimaryChange From Baseline in Laboratory Values (%)

Change in laboratory values was assessed for clinical relevance

Time frame:
Baseline to Day 28
Reported as:
Mean · % of cells
Change From Baseline in Laboratory Values (%)
% of cellsTapinarof Cream
Basophils/Total cells (%)0.05 ± 0.343
Eosinophils/Total cells (%)-0.13 ± 4.606
Lymphocytes/Total cells (%)0.81 ± 11.023
Monocytes/Total cells (%)-0.81 ± 2.662
Neutrophils/Total cells (%)0.08 ± 12.693
Reticulocytes/Erythrocytes (%)0.06 ± 0.377
PrimaryChange From Baseline in Laboratory Values (pg)

Change in Ery. mean corpuscular hemoglobin laboratory values was assessed for clinical relevance

Time frame:
Baseline to Day 28
Reported as:
Mean · pg
Change From Baseline in Laboratory Values (pg)
pgTapinarof Cream
Change From Baseline in Laboratory Values (pg)0.26 ± 0.787
PrimaryChange From Baseline in Laboratory Values (fL)

Change in Ery. mean corpuscular volume laboratory values was assessed for clinical relevance

Time frame:
Baseline to Day 28
Reported as:
Mean · fL
Change From Baseline in Laboratory Values (fL)
fLTapinarof Cream
Change From Baseline in Laboratory Values (fL)1.26 ± 1.973
PrimaryChange From Baseline in Laboratory Values (10^12 Cells/L)

Change in Erythrocytes laboratory values was assessed for clinical relevance

Time frame:
Baseline to Day 28
Reported as:
Mean · 10^12 cells/L
Change From Baseline in Laboratory Values (10^12 Cells/L)
10^12 cells/LTapinarof Cream
Change From Baseline in Laboratory Values (10^12 Cells/L)-0.055 ± 0.2481
PrimaryChange From Baseline in Laboratory Values (L/L)

Change in Hematocrit laboratory values was assessed for clinical relevance

Time frame:
Baseline to Day 28
Reported as:
Mean · L/L
Change From Baseline in Laboratory Values (L/L)
L/LTapinarof Cream
Change From Baseline in Laboratory Values (L/L)0.002 ± 0.0228
PrimaryMean 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.

Time frame:
Baseline to Day 28
Reported as:
Mean · Units on a scale
Mean Change in Local Tolerability Scale (LTS)
Units on a scaleTapinarof Cream
Baseline0.2 ± 0.68
Day 280.1 ± 0.40
PrimaryTapinarof Plasma PK Parameters on Day 1: AUC0-τ

The AUC in plasma is a pharmacokinetic parameter that describes the overall exposure of the drug.

Time frame:
Day 1 (PK samples collected pre-dose and at 1, 3, and 5 hours post-dose)
Reported as:
Mean · pg*h/mL
Tapinarof Plasma PK Parameters on Day 1: AUC0-τ
pg*h/mLTapinarof Cream
Tapinarof Plasma PK Parameters on Day 1: AUC0-τ4690 ± 5600
PrimaryTapinarof 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.

Time frame:
Day 1 (PK samples collected pre-dose and at 1, 3, and 5 hours post-dose)
Reported as:
Mean · pg/mL
Tapinarof Plasma PK Parameters on Day 1: Cmax
pg/mLTapinarof Cream
Tapinarof Plasma PK Parameters on Day 1: Cmax2440 ± 3900
PrimaryTapinarof 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.

Time frame:
Day 1 (PK samples collected pre-dose and at 1, 3, and 5 hours post-dose)
Reported as:
Mean · hour
Tapinarof Plasma PK Parameters on Day 1: Tmax
hourTapinarof Cream
Tapinarof Plasma PK Parameters on Day 1: Tmax2.37 ± 1.19
PrimaryTapinarof Plasma Concentration: Cτ

The Cτ is a pharmacokinetic parameter that is the last quantifiable concentration determined directly from individual concentration-time data

Time frame:
Day 1 (PK samples collected pre-dose and at 1, 3, and 5 hours post-dose)
Reported as:
Mean · pg/mL
Tapinarof Plasma Concentration: Cτ
pg/mLTapinarof Cream
Tapinarof Plasma Concentration: Cτ1330 ± 3780
PrimaryChange From Baseline in Vital Signs (Beats/Min)

Change in pulse vital signs was assessed for clinical relevance

Time frame:
Baseline to Day 28
Reported as:
Mean · Beats/Min
Change From Baseline in Vital Signs (Beats/Min)
Beats/MinTapinarof Cream
Change From Baseline in Vital Signs (Beats/Min)0.9 ± 14.40
PrimaryChange From Baseline in Vital Signs (mmHg)

Change in Blood Pressure vital signs was assessed for clinical relevance

Time frame:
Baseline to Day 28
Reported as:
Mean · mmHg
Change From Baseline in Vital Signs (mmHg)
mmHgTapinarof Cream
Systolic Blood Pressure (mmHg)1.1 ± 8.78
Diastolic Blood Pressure (mmHg)-0.9 ± 6.63
PrimaryChange From Baseline in Vital Signs (C)

Change in Temperature vital signs was assessed for clinical relevance

Time frame:
Baseline to Day 28
Reported as:
Mean · degrees C
Change From Baseline in Vital Signs (C)
degrees CTapinarof Cream
Change From Baseline in Vital Signs (C)-0.08 ± 0.402
SecondaryChange 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.

Time frame:
Baseline to Day 28
Reported as:
Count of participants · Participants
Change From Baseline in Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD)
ParticipantsTapinarof Cream
+4 = worsened by 40
+3 = worsened by 30
+2 = worsened by 20
+1 = worsened by 10
0 - no change8
-1 = improved by 114
-2 = improved by 28
-3 = improved by 32
-4 = improved by 40
SecondaryNumber 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.

Time frame:
Baseline to Day 28
Reported as:
Count of participants · Participants
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
ParticipantsTapinarof Cream
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 Baseline8
SecondaryNumber 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.

Time frame:
Baseline to Day 28
Reported as:
Count of participants · Participants
Number of Subjects With ≥50%, Improvement in Eczema Area and Severity Index (EASI) Score
ParticipantsTapinarof Cream
Number of Subjects With ≥50%, Improvement in Eczema Area and Severity Index (EASI) Score20
SecondaryNumber 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.

Time frame:
Baseline to Day 28
Reported as:
Count of participants · Participants
Number of Subjects With ≥75%, Improvement in Eczema Area and Severity Index (EASI) Score
ParticipantsTapinarof Cream
Number of Subjects With ≥75%, Improvement in Eczema Area and Severity Index (EASI) Score7
SecondaryNumber 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.

Time frame:
Baseline to Day 28
Reported as:
Count of participants · Participants
Number of Subjects With ≥90%, Improvement in Eczema Area and Severity Index (EASI) Score
ParticipantsTapinarof Cream
Number of Subjects With ≥90%, Improvement in Eczema Area and Severity Index (EASI) Score4
SecondaryMean 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.

Time frame:
Baseline to Day 28
Reported as:
Mean · scores on a scale
Mean Change in Eczema Area and Severity Index EASI From Baseline to Day 28
scores on a scaleTapinarof Cream
Mean Change in Eczema Area and Severity Index EASI From Baseline to Day 28-12.16 ± 9.742
SecondaryPercent 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.

Time frame:
Baseline to Day 28
Reported as:
Mean · % change from baseline
Percent Change in Eczema Area and Severity Index EASI From Baseline to Day 28
% change from baselineTapinarof Cream
Percent Change in Eczema Area and Severity Index EASI From Baseline to Day 28-53.38 ± 38.337
SecondaryMean 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.

Time frame:
Baseline to Day 28
Reported as:
Mean · percentage of BSA
Mean Change in Percent of Total Body Surface Area (%BSA) Affected
percentage of BSATapinarof Cream
Mean Change in Percent of Total Body Surface Area (%BSA) Affected-21.06 ± 18.789
SecondaryPercent 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.

Time frame:
Baseline to Day 28
Reported as:
Mean · % change from baseline
Percent Change in Percent of Total Body Surface Area (%BSA) Affected
% change from baselineTapinarof Cream
Percent Change in Percent of Total Body Surface Area (%BSA) Affected-49.40 ± 41.3000
SecondaryMean 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. \[Total Body Surface Area (BSA) x Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD)\]

Time frame:
Baseline to Day 28
Reported as:
Mean · unitless
Mean Change in Total Body Surface Area (BSA) x Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD) Values
unitlessTapinarof Cream
Mean Change in Total Body Surface Area (BSA) x Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD) Values-85.15 ± 65.848
SecondaryPercent 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)

Time frame:
Baseline to Day 28
Reported as:
Mean · % change from baseline
Percent Change in Total Body Surface Area (BSA) x Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD) Values
% change from baselineTapinarof Cream
Percent Change in Total Body Surface Area (BSA) x Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD) Values-62.77 ± 35.290
SecondaryMean 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.

Time frame:
Baseline to Day 28
Reported as:
Mean · Units on a scale
Mean Change in Average Weekly Peak Pruritus Numerical Rating Scale (PP-NRS) Score
Units on a scaleTapinarof Cream
Mean Change in Average Weekly Peak Pruritus Numerical Rating Scale (PP-NRS) Score-4.155 ± 2.4558
SecondaryProportion 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.

Time frame:
Baseline to Day 28
Reported as:
Count of participants · 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
ParticipantsTapinarof Cream
Achieved ≥ 4-Point Reduction from Baseline in the Average Weekly PP-NRS Score14
Failure to Achieve a ≥ 4-point Reduction from Baseline in the Average Weekly PP-NRS Score18

Adverse events

Collected over Baseline to Day 28 for subjects enrolling in Long-Term Extension (LTE), otherwise to Day 35. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Tapinarof Cream0/36 (0%)0/36 (0%)8/36 (22.2%)
Most frequent other events
Most frequent other events
EventTapinarof Cream
HeadacheNervous system disorders3/36
VomitingGastrointestinal disorders2/36
NauseaGastrointestinal disorders1/36
FolliculitisInfections and infestations1/36
InfluenzaInfections and infestations1/36
PustuleInfections and infestations1/36
LymphadenopathyBlood and lymphatic system disorders1/36
Tranaminases increasedInvestigations1/36
ErythemaSkin and subcutaneous tissue disorders1/36

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Tapinarof Cream
<=18 years36
Between 18 and 65 years0
>=65 years0
Age, Continuous
Age, Continuous(years)Tapinarof Cream
Mean8.9 ± 4.85
Sex: Female, Male
Sex: Female, Male(Participants)Tapinarof Cream
Female12
Male24
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Tapinarof Cream
Hispanic or Latino18
Not Hispanic or Latino18
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Tapinarof Cream
American Indian or Alaska Native0
Asian3
Native Hawaiian or Other Pacific Islander0
Black or African American6
White27
More than one race0
Unknown or Not Reported0
Validated Investigator Global Assessment for Atopic Dermatitis
Validated Investigator Global Assessment for Atopic Dermatitis(Participants)Tapinarof Cream
0 - Clear0
1 - Almost Clear0
2 - Mild0
3 - Moderate28
4 - Severe8
08

Study locations

10 sites
  • Dermavant Investigative Site
    Thousand Oaks, California 91320, United States
  • Dermavant Investigative Site
    Centennial, Colorado 80112, United States
  • Dermavant Investigative Site
    Coral Gables, Florida 33146, United States
  • Dermavant Investigative Site
    Hialeah, Florida 33016, United States
  • Dermavant Investigative Site
    Miami Lakes, Florida 33014, United States
  • Dermavant Investigative Site
    Chicago, Illinois 60611, United States
  • Dermavant Investigative Site
    Summerville, South Carolina 29445, United States
  • Dermavant Investigative Site
    Houston, Texas 77030, United States
  • Dermavant Investigative Site
    San Antonio, Texas 78213, United States
  • Dermavant Investigative Site
    Calgary, Alberta T3A 2N1, Canada
09

References and documents

Publications

  • Bashaw ED, Tran DC, Shukla CG, Liu X. Maximal Usage Trial: An Overview of the Design of Systemic Bioavailability Trial for Topical Dermatological Products. Ther Innov Regul Sci. 2015 Jan;49(1):108-115. doi: 10.1177/2168479014539157. Epub 2014 Jun 27. PubMed 26634191 ↗
  • Bieber T. Atopic dermatitis. N Engl J Med. 2008 Apr 3;358(14):1483-94. doi: 10.1056/NEJMra074081. No abstract available. PubMed 18385500 ↗
  • Cappon GD and Hurtt ME. Developmental toxicity of the kidney. In: Kapp RW and Yyl L, editors. Reproductive Toxicology, Target Organ Series, 3rd edition. New York:Informa Healthcare, 2010:193-204.
  • Carroll CL, Balkrishnan R, Feldman SR, Fleischer AB Jr, Manuel JC. The burden of atopic dermatitis: impact on the patient, family, and society. Pediatr Dermatol. 2005 May-Jun;22(3):192-9. doi: 10.1111/j.1525-1470.2005.22303.x. PubMed 15916563 ↗
  • Frazier KS and Seely JC. Urinary system. In: Sahota PS, Popp JA, Hardisty JF and Gopinath C, editors. Toxicologic Pathology. Nonclinical Safety Assessment. CRC Press, 2013:421-84.
  • Furue M, Hashimoto-Hachiya A, Tsuji G. Aryl Hydrocarbon Receptor in Atopic Dermatitis and Psoriasis. Int J Mol Sci. 2019 Oct 31;20(21):5424. doi: 10.3390/ijms20215424. PubMed 31683543 ↗
  • Hanifin JM, Rajka G. Diagnostic features of atopic dermatitis. Acta Dermato-Venereologica Supplementum. 1980;92:44-7.
  • Hanifin JM, Thurston M, Omoto M, Cherill R, Tofte SJ, Graeber M. The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. EASI Evaluator Group. Exp Dermatol. 2001 Feb;10(1):11-8. doi: 10.1034/j.1600-0625.2001.100102.x. PubMed 11168575 ↗
  • Kalia YN, Nonato LB, Lund CH, Guy RH. Development of skin barrier function in premature infants. J Invest Dermatol. 1998 Aug;111(2):320-6. doi: 10.1046/j.1523-1747.1998.00289.x. PubMed 9699737 ↗
  • Lewis-Jones S. Quality of life and childhood atopic dermatitis: the misery of living with childhood eczema. Int J Clin Pract. 2006 Aug;60(8):984-92. doi: 10.1111/j.1742-1241.2006.01047.x. PubMed 16893440 ↗
  • Nikolovski J, Stamatas GN, Kollias N, Wiegand BC. Barrier function and water-holding and transport properties of infant stratum corneum are different from adult and continue to develop through the first year of life. J Invest Dermatol. 2008 Jul;128(7):1728-36. doi: 10.1038/sj.jid.5701239. Epub 2008 Jan 17. PubMed 18200056 ↗
  • Peppers J, Paller AS, Maeda-Chubachi T, Wu S, Robbins K, Gallagher K, Kraus JE. A phase 2, randomized dose-finding study of tapinarof (GSK2894512 cream) for the treatment of atopic dermatitis. J Am Acad Dermatol. 2019 Jan;80(1):89-98.e3. doi: 10.1016/j.jaad.2018.06.047. Epub 2018 Jul 3. PubMed 30554600 ↗
  • Smith SH, Jayawickreme C, Rickard DJ, Nicodeme E, Bui T, Simmons C, Coquery CM, Neil J, Pryor WM, Mayhew D, Rajpal DK, Creech K, Furst S, Lee J, Wu D, Rastinejad F, Willson TM, Viviani F, Morris DC, Moore JT, Cote-Sierra J. Tapinarof Is a Natural AhR Agonist that Resolves Skin Inflammation in Mice and Humans. J Invest Dermatol. 2017 Oct;137(10):2110-2119. doi: 10.1016/j.jid.2017.05.004. Epub 2017 Jun 6. PubMed 28595996 ↗
  • Zoetis T, Hurtt ME. Species comparison of anatomical and functional renal development. Birth Defects Res B Dev Reprod Toxicol. 2003 Apr;68(2):111-20. doi: 10.1002/bdrb.10013. No abstract available. PubMed 12866702 ↗
  • Paller AS, Hebert AA, Gonzalez ME, Butners V, Fitzgerald N, Tabolt G, Rubenstein DS, Piscitelli SC. Maximal Usage Trial of Tapinarof Cream 1% Once Daily in Pediatric Patients Down to 2 Years of Age with Extensive Atopic Dermatitis. Am J Clin Dermatol. 2025 May;26(3):449-456. doi: 10.1007/s40257-025-00929-9. Epub 2025 Mar 24. PubMed 40126804 ↗

Study documents

  • Study protocol · Mar 25, 2021
  • Statistical analysis plan · Sep 8, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05186805
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
Jan 11, 2022
Start date
Nov 15, 2021
Primary completion
Aug 24, 2022
Completion
Aug 24, 2022
Results posted
Sep 5, 2025
Last update
Sep 5, 2025

Study contacts

Diana Villalobos
study director · Dermavant Sciences, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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