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

NCT05186805 | Completed Phase 2 Results FDA Drug

• 1 other identifier: DMVT-505-2104
• Study Type: interventional
• Target: 36
• Locations: 2 countries
• Sites: 10

Brief 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

Conditions

Atopic Dermatitis

Keywords

eczema; pediatric; tapinarof; phase 2; topical

Outcome Measures

Primary Outcomes (19)

• 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).

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

• Change From Baseline in Laboratory Values (U/L)

  Change in laboratory values was assessed for clinical relevance

  Baseline to Day 28

• Change From Baseline in Laboratory Values (g/L)

  Change in laboratory values was assessed for clinical relevance

  Baseline to Day 28

• Change From Baseline in Laboratory Values (mmol/L)

  Change in laboratory values was assessed for clinical relevance

  Baseline to Day 28

• Change From Baseline in Laboratory Values (Umol/L)

  Change in laboratory values was assessed for clinical relevance

  Baseline to Day 28

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

  Change in laboratory values was assessed for clinical relevance

  Baseline to Day 28

• Change From Baseline in Laboratory Values (%)

  Change in laboratory values was assessed for clinical relevance

  Baseline to Day 28

• Change From Baseline in Laboratory Values (pg)

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

  Baseline to Day 28

• Change From Baseline in Laboratory Values (fL)

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

  Baseline to Day 28

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

  Change in Erythrocytes laboratory values was assessed for clinical relevance

  Baseline to Day 28

• Change From Baseline in Laboratory Values (L/L)

  Change in Hematocrit laboratory values was assessed for clinical relevance

  Baseline to Day 28

• 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.

  Baseline to Day 28

• 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.

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

• 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.

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

• 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.

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

• Tapinarof Plasma Concentration: Cτ

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

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

• Change From Baseline in Vital Signs (Beats/Min)

  Change in pulse vital signs was assessed for clinical relevance

  Baseline to Day 28

• Change From Baseline in Vital Signs (mmHg)

  Change in Blood Pressure vital signs was assessed for clinical relevance

  Baseline to Day 28

• Change From Baseline in Vital Signs (C)

  Change in Temperature vital signs was assessed for clinical relevance

  Baseline to Day 28

Secondary Outcomes (13)

• Change From Baseline in Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD)

  Baseline to Day 28

• 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

  Baseline to Day 28

• Number of Subjects With ≥50%, Improvement in Eczema Area and Severity Index (EASI) Score

  Baseline to Day 28

• Number of Subjects With ≥75%, Improvement in Eczema Area and Severity Index (EASI) Score

  Baseline to Day 28

• Number of Subjects With ≥90%, Improvement in Eczema Area and Severity Index (EASI) Score

  Baseline to Day 28

Study Arms (1)

tapinarof cream

EXPERIMENTAL

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

Drug: Tapinarof cream, 1%

Interventions

Tapinarof cream, 1% DRUG

Tapinarof cream, 1% applied topically once daily

Also known as: DMVT-505

tapinarof cream

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Organon and Co: lead

Study Sites (10)

Dermavant Investigative Site

Thousand Oaks, California, 91320, United States

Location

Dermavant Investigative Site

Centennial, Colorado, 80112, United States

Location

Dermavant Investigative Site

Coral Gables, Florida, 33146, United States

Location

Dermavant Investigative Site

Hialeah, Florida, 33016, United States

Location

Dermavant Investigative Site

Miami Lakes, Florida, 33014, United States

Location

Dermavant Investigative Site

Chicago, Illinois, 60611, United States

Location

Dermavant Investigative Site

Summerville, South Carolina, 29445, United States

Location

Dermavant Investigative Site

Houston, Texas, 77030, United States

Location

Dermavant Investigative Site

San Antonio, Texas, 78213, United States

Location

Dermavant Investigative Site

Calgary, Alberta, T3A 2N1, Canada

Location

Related Publications (15)

• 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.

  PMID: 26634191 BACKGROUND

• Bieber T. Atopic dermatitis. N Engl J Med. 2008 Apr 3;358(14):1483-94. doi: 10.1056/NEJMra074081. No abstract available.

  PMID: 18385500 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 15916563 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 31683543 BACKGROUND

• Hanifin JM, Rajka G. Diagnostic features of atopic dermatitis. Acta Dermato-Venereologica Supplementum. 1980;92:44-7.

  BACKGROUND

• 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.

  PMID: 11168575 BACKGROUND

• 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.

  PMID: 9699737 BACKGROUND

• 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.

  PMID: 16893440 BACKGROUND

• 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.

  PMID: 18200056 BACKGROUND

• 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.

  PMID: 30554600 BACKGROUND

• 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.

  PMID: 28595996 BACKGROUND

• 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.

  PMID: 12866702 BACKGROUND

• 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.

  PMID: 40126804 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Clinical Lead, Late-Stage Clinical Development
• Organization: Organon and Co

pdrl@organon.com

551-430-6000

Study Officials

• Diana Villalobos

  Dermavant Sciences, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: January 11, 2022
• Study Start: November 15, 2021
• Primary Completion: August 24, 2022
• Study Completion: August 24, 2022
• Last Updated: September 5, 2025
• Results First Posted: September 5, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (9)