Study Summary
This trial is testing a new cream to see if it helps kids with plaque psoriasis.
Eligible Conditions
- Plaque Psoriasis
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
5 Primary · 3 Secondary · Reporting Duration: Week 4 and Week 12
Week 52
Investigator-Assessed Local Tolerability Scale (LTS) Scores
Subject (or Caregiver)-Assessed Local Tolerability Scale (LTS)
Week 53
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of subjects with clinically significant laboratory test abnormalities
Number of subjects with clinically significant vital signs abnormalities
Week 12
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Detectable Time-Point (AUC0-t) of tapinarof cream, 1%.
Maximum Plasma Concentration (Cmax) of tapinarof cream, 1%.
Time to Maximum Plasma Concentration (tmax) of tapinarof cream, 1%.
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Side Effects for
Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score
23%Folliculitis
6%Dermatitis contact
Trial Design
1 Treatment Group
Open Label
1 of 1
Experimental Treatment
100 Total Participants · 1 Treatment Group
Primary Treatment: tapinarof cream, 1% · No Placebo Group · Phase 3
Open Label
Drug
Experimental Group · 1 Intervention: tapinarof cream, 1% · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tapinarof
Not yet FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 4 and week 12
Who is running the clinical trial?
Dermavant Sciences, Inc.Lead Sponsor
3 Previous Clinical Trials
1,027 Total Patients Enrolled
Diana VillalobosStudy DirectorDermavant Sciences, Inc.
4 Previous Clinical Trials
1,797 Total Patients Enrolled
Eligibility Criteria
Age 2 - 17 · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
How old are they?
| 18 - 65 | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 50.0% |
| Did not meet criteria | 50.0% |
References
- 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:;93-204.
- Fredriksson, T., and U. Pettersson. 1978. “Severe Psoriasis – Oral Therapy with a New Retinoid”. Dermatology. S. Karger AG. doi:10.1159/000250839.
- Furue, Masutaka, Akiko Hashimoto-Hachiya, and Gaku Tsuji. 2019. “Aryl Hydrocarbon Receptor in Atopic Dermatitis and Psoriasis”. International Journal of Molecular Sciences. MDPI AG. doi:10.3390/ijms20215424.
- 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.
- Basra, M.K.A., M.S. Salek, L. Camilleri, R. Sturkey, and A.Y. Finlay. 2015. “Determining the Minimal Clinically Important Difference and Responsiveness of the Dermatology Life Quality Index (DLQI): Further Data”. Dermatology. S. Karger AG. doi:10.1159/000365390.
- Langley, R G B. 2005. “Psoriasis: Epidemiology, Clinical Features, and Quality of Life”. Annals of the Rheumatic Diseases. BMJ. doi:10.1136/ard.2004.033217.
- Parisi, Rosa, Deborah P.M. Symmons, Christopher E.M. Griffiths, and Darren M. Ashcroft. 2013. “Global Epidemiology of Psoriasis: A Systematic Review of Incidence and Prevalence”. Journal of Investigative Dermatology. Elsevier BV. doi:10.1038/jid.2012.339.
- Nikolovski, Janeta, Georgios N. Stamatas, Nikiforos Kollias, and Benjamin C. Wiegand. 2008. “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”. Journal of Investigative Dermatology. Elsevier BV. doi:10.1038/sj.jid.5701239.
- Zoetis, Tracey, and Mark E. Hurtt. 2003. “Species Comparison of Anatomical and Functional Renal Development”. Birth Defects Research Part B: Developmental and Reproductive Toxicology. Wiley. doi:10.1002/bdrb.10013.
- Tollefson, Megha M., Dawn M. Finnie, Jennifer J. Schoch, and David T. Eton. 2017. “Impact of Childhood Psoriasis on Parents of Affected Children”. Journal of the American Academy of Dermatology. Elsevier BV. doi:10.1016/j.jaad.2016.09.014.
- Kalia, Yogeshvar N., Lourdes B. Nonato, Carolyn H. Lund, and Richard H. Guy. 1998. “Development of Skin Barrier Function in Premature Infants”. Journal of Investigative Dermatology. Elsevier BV. doi:10.1046/j.1523-1747.1998.00289.x.
- Smith, Susan H., Channa Jayawickreme, David J. Rickard, Edwige Nicodeme, Thi Bui, Cathy Simmons, Christine M. Coquery, et al.. 2017. “Tapinarof Is a Natural Ahr Agonist That Resolves Skin Inflammation in Mice and Humans”. Journal of Investigative Dermatology. Elsevier BV. doi:10.1016/j.jid.2017.05.004.
- Burden‐Teh, E., K.S. Thomas, S. Ratib, D. Grindlay, E. Adaji, and R. Murphy. 2016. “The Epidemiology of Childhood Psoriasis: A Scoping Review”. British Journal of Dermatology. Wiley. doi:10.1111/bjd.14507.
- Bronckers, I. M. G. J., A. S. Paller, M. J. van Geel, P. C. M. van de Kerkhof, and M. M. B. Seyger. 2015. “Psoriasis in Children and Adolescents: Diagnosis, Management and Comorbidities”. Pediatric Drugs. Springer Science and Business Media LLC. doi:10.1007/s40272-015-0137-1.
- Boehncke, Wolf-Henning, and Michael P Schön. 2015. “Psoriasis”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(14)61909-7.
- Nestle, Frank O., Daniel H. Kaplan, and Jonathan Barker. 2009. “Psoriasis”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmra0804595.
- Mason AR, Mason J, Cork M, Dooley G, Hancock H. Topical treatments for chronic plaque psoriasis. Cochrane Database Syst Rev. 2013 Mar 28;(3):CD005028. doi: 10.1002/14651858.CD005028.pub3. Review.
- Evans, N.J., and N. Rutter. 1986. “Development of the Epidermis in the Newborn”. Neonatology. S. Karger AG. doi:10.1159/000242513.
- Thomas, C.L., and A.Y. Finlay. 2007. “The ‘handprint’ Approximates to 1% of the Total Body Surface Area Whereas the ‘palm Minus the Fingers’ Does Not”. British Journal of Dermatology. Wiley. doi:10.1111/j.1365-2133.2007.08183.x.
- 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.
- Thomas CL, Finlay AY. The 'handprint' approximates to 1% of the total body surface area whereas the 'palm minus the fingers' does not. Br J Dermatol. 2007 Nov;157(5):1080-1. doi: 10.1111/j.1365-2133.2007.08183.x. Epub 2007 Sep 13. No abstract available.
- Boehncke WH, Schon MP. Psoriasis. Lancet. 2015 Sep 5;386(9997):983-94. doi: 10.1016/S0140-6736(14)61909-7. Epub 2015 May 27.
- Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med. 2009 Jul 30;361(5):496-509. doi: 10.1056/NEJMra0804595. No abstract available.
- Fredriksson T, Pettersson U. Severe psoriasis--oral therapy with a new retinoid. Dermatologica. 1978;157(4):238-44. doi: 10.1159/000250839.
- Parisi R, Symmons DP, Griffiths CE, Ashcroft DM; Identification and Management of Psoriasis and Associated ComorbidiTy (IMPACT) project team. Global epidemiology of psoriasis: a systematic review of incidence and prevalence. J Invest Dermatol. 2013 Feb;133(2):377-85. doi: 10.1038/jid.2012.339. Epub 2012 Sep 27.
- 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.
- 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.
- Langley RG, Krueger GG, Griffiths CE. Psoriasis: epidemiology, clinical features, and quality of life. Ann Rheum Dis. 2005 Mar;64 Suppl 2(Suppl 2):ii18-23; discussion ii24-5. doi: 10.1136/ard.2004.033217.
- Mason AR, Mason J, Cork M, Dooley G, Hancock H. Topical treatments for chronic plaque psoriasis. Cochrane Database Syst Rev. 2013 Mar 28;(3):CD005028. doi: 10.1002/14651858.CD005028.pub3.
- Bronckers IM, Paller AS, van Geel MJ, van de Kerkhof PC, Seyger MM. Psoriasis in Children and Adolescents: Diagnosis, Management and Comorbidities. Paediatr Drugs. 2015 Oct;17(5):373-84. doi: 10.1007/s40272-015-0137-1.
- Evans NJ, Rutter N. Development of the epidermis in the newborn. Biol Neonate. 1986;49(2):74-80. doi: 10.1159/000242513.
- Burden-Teh E, Thomas KS, Ratib S, Grindlay D, Adaji E, Murphy R. The epidemiology of childhood psoriasis: a scoping review. Br J Dermatol. 2016 Jun;174(6):1242-57. doi: 10.1111/bjd.14507. Epub 2016 May 22.
- 2021. "Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05172726.
Frequently Asked Questions
Are there any restrictions on where this clinical trial can be accessed?
"This study is looking for participants from 11 different locations, which are listed on the website. If you are considering participating, it might be helpful to choose a site that is close to your home to avoid extra travel." - Anonymous Online Contributor
Unverified Answer
At what age does this trial cutoff for participants?
"According to the study's inclusion criteria, patients between the ages of 2 and 17 are eligible to participate. There are a total of 36 trials for people under 18 and 159 for people over 65." - Anonymous Online Contributor
Unverified Answer
How many people are being selected to participate in this research?
"Yes, the information on clinicaltrials.gov says that this trial is currently searching for candidates. The study was originally posted on December 2nd, 2021 and was most recently edited on February 23rd, 2022. The trial is looking for 100 participants at 11 sites." - Anonymous Online Contributor
Unverified Answer
Are the results of this study on tapinarof cream, 1% in line with previous research?
"5 clinical trials for tapinarof cream, 1% are currently active, with 4 of those being Phase 3 trials. Rogers, Arkansas is the location for many of the trials, but there are a total of 232 sites running trials for this cream." - Anonymous Online Contributor
Unverified Answer
Are there any short or long-term risks associated with tapinarof cream, 1%?
"There is some evidence of efficacy and extensive safety data available, so our team at Power gave tapinarof cream, 1% a score of 3." - Anonymous Online Contributor
Unverified Answer
Which types of people would be able to join this research project?
"The aim of this study is to enrol 100 individuals with psoriasis aged 2-17. To be eligible, patients must: be male or female, have had the disease for 3 months or more, have plaque psoriasis covering 3% or more of their body, have a PGA score of 2 or more, not be pregnant, and use birth control if they are sexually active and of childbearing age." - Anonymous Online Contributor
Unverified Answer
Are new participants still being welcomed into this research project?
"Correct, the listed clinical trial on clinicaltrials.gov is actively recruiting patients. The posting date was December 2nd, 2021 and the most recent update was on February 23rd, 2022. They are looking for 100 patients that can visit one of the 11 locations." - Anonymous Online Contributor
Unverified Answer