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Atopic DermatitisPhase 2NCT05186805

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

A Phase 2 study testing Tapinarof cream, 1% in people with Atopic Dermatitis, run by Organon and Co at 10 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 more about this study

Who is it for?
Ages 2 to 17 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
Tapinarof cream, 1%
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
10 sitesin 2 countries
Study dates
15 Nov 2021to 24 Aug 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 13Show fewer
  • 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)

Trial locations and contacts

10 sites in 2 countries.

10 sites in 2 countries

United States9 sites

  • Dermavant Investigative Site

    Centennial, Colorado, 80112

  • Dermavant Investigative Site

    Chicago, Illinois, 60611

  • Dermavant Investigative Site

    Coral Gables, Florida, 33146

  • Dermavant Investigative Site

    Hialeah, Florida, 33016

  • Dermavant Investigative Site

    Houston, Texas, 77030

  • Dermavant Investigative Site

    Miami Lakes, Florida, 33014

  • Dermavant Investigative Site

    San Antonio, Texas, 78213

  • Dermavant Investigative Site

    Summerville, South Carolina, 29445

  • Dermavant Investigative Site

    Thousand Oaks, California, 91320

Other trials in United States

Canada1 site

  • Dermavant Investigative Site

    Calgary, Alberta, T3A 2N1

Other trials in Canada

About this study

Official title: Open Label Maximal Use Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Tapinarof Cream, 1% in Pediatric Subjects With Extensive Atopic Dermatitis

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.

Being tested
Tapinarof cream, 1%
Keywords
eczema, pediatric, tapinarof, phase 2, topical
Medical subject headings
Dermatitis, Atopic, Eczema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tapinarof cream, 1%Drug

    Also called DMVT-505

    Tapinarof cream, 1% applied topically once daily

Study groups in NCT05186805
Study groupRoleWhat they receive
tapinarof creamExperimentalTapinarof (DMVT-505) cream, 1% applied topically once daily
Receives: Drug: Tapinarof cream, 1%

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 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

    Measured: Baseline to Day 28

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

    Change in laboratory values was assessed for clinical relevance

    Measured: Baseline to Day 28

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

    Change in laboratory values was assessed for clinical relevance

    Measured: Baseline to Day 28

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

    Change in laboratory values was assessed for clinical relevance

    Measured: Baseline to Day 28

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

    Change in laboratory values was assessed for clinical relevance

    Measured: Baseline to Day 28

  7. Change From Baseline in Laboratory Values (%)

    Change in laboratory values was assessed for clinical relevance

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Baseline to Day 28

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

    Change in Hematocrit laboratory values was assessed for clinical relevance

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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

    Measured: 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

    Measured: Baseline to Day 28

  18. Change From Baseline in Vital Signs (mmHg)

    Change in Blood Pressure vital signs was assessed for clinical relevance

    Measured: Baseline to Day 28

  19. Change From Baseline in Vital Signs (C)

    Change in Temperature vital signs was assessed for clinical relevance

    Measured: Baseline to Day 28

Secondary outcomes (13)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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)]

    Measured: 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)

    Measured: 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.

    Measured: 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.

    Measured: Baseline to Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2022
  2. Study start15 Nov 2021
  3. Primary completion24 Aug 2022
  4. Study completion24 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05186805
Sponsor's protocol ID
DMVT-505-2104
Status last verified
Sep 2025
First submitted
8 Nov 2021
Last updated
5 Sep 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tapinarof cream, 1% in people with Atopic Dermatitis, run by Organon and Co at 10 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05186805, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.

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