100 Participants Needed

Tapinarof Cream for Plaque Psoriasis

Recruiting at 17 trial locations
AD
AL
DF
NK
AL
KS
SK
JW
Overseen ByJennifer Wood
Age: < 18
Sex: Any
Trial Phase: Phase 3
Sponsor: Dermavant Sciences, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This is an open-label, multi-center, Phase 3 study to evaluate tapinarof cream, 1% in pediatric subjects with plaque psoriasis.

Will I have to stop taking my current medications?

The trial information does not clearly state if you need to stop taking your current medications. However, it mentions that the use of any prohibited medication is not allowed during the study, so you may need to discuss your current medications with the study team.

Is Tapinarof cream safe for human use?

Tapinarof cream has been shown to be generally safe for human use, with common side effects including folliculitis (inflammation of hair follicles), contact dermatitis (skin irritation), headache, and upper respiratory tract infection. These findings are based on clinical trials for plaque psoriasis, and no new safety concerns were identified in extended studies.12345

How is the drug Tapinarof cream unique for treating plaque psoriasis?

Tapinarof cream is unique because it is a topical treatment that works by activating aryl hydrocarbon receptors, which help regulate the immune response and maintain skin health. Unlike traditional treatments like corticosteroids, it offers a novel mechanism of action with promising results in clinical trials.13567

Research Team

DV

Diana Villalobos

Principal Investigator

Dermavant Sciences, Inc.

Eligibility Criteria

This trial is for children and teens aged 2 to 17 with chronic plaque psoriasis covering at least 3% of their body. They must have had stable disease for the past three months, not be pregnant or immunocompromised, and have normal liver function tests. Girls who can get pregnant must use birth control.

Inclusion Criteria

I am between 2 and 17 years old with stable chronic plaque psoriasis for at least 3 months.
My psoriasis covers 3% or more of my body.
I, or my legal guardian, can sign the consent form.
See 3 more

Exclusion Criteria

I haven't used any forbidden medications or procedures recently.
Pregnant or lactating females
I have previously participated in a study involving tapinarof.
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tapinarof cream, 1% once daily for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Long-term extension (optional)

Participants may opt into continuation of treatment with tapinarof cream for an additional 40 weeks

40 weeks

Treatment Details

Interventions

  • Tapinarof
Trial Overview The study is testing tapinarof cream, a medication applied to the skin, in kids with plaque psoriasis. It's an open-label Phase 3 trial which means everyone knows they're getting tapinarof and it's being tested for safety and effectiveness.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Open LabelExperimental Treatment1 Intervention

Tapinarof is already approved in United States for the following indications:

🇺🇸
Approved in United States as Vtama for:
  • Plaque psoriasis in adults
  • Atopic dermatitis in adults and pediatric patients 2 years of age and older

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dermavant Sciences, Inc.

Lead Sponsor

Trials
9
Recruited
1,800+

Findings from Research

Tapinarof, a new topical treatment for plaque psoriasis, was approved by the FDA in May 2022 and has shown proven efficacy and safety in clinical studies, making it a promising option for adults with this condition.
Unlike traditional topical corticosteroids, which can have adverse effects and limitations, tapinarof offers a novel mechanism of action by modulating the aryl hydrocarbon receptor, potentially improving patient care in managing psoriasis.
A Review of Tapinarof: Novel Topical Treatment for Plaque Psoriasis in Adults.Kalabalik-Hoganson, J., Nogid, A., Frey, K.[2023]
Tapinarof, a new topical treatment for plaque psoriasis, has shown significant efficacy in two phase III trials, with 35.4%-40.2% of patients achieving a favorable response compared to only 6.0%-6.3% in the placebo group.
The treatment demonstrated a favorable safety profile over 40 weeks, with common side effects being mild (like folliculitis and contact dermatitis) and no new safety concerns identified, making it a promising alternative to existing therapies.
Tapinarof for the treatment of psoriasis.Nogueira, S., Rodrigues, MA., Vender, R., et al.[2023]
Tapinarof (VTAMA®) 1% cream is an effective new treatment for plaque psoriasis, showing significant improvement in 35.4% to 40.2% of patients compared to only 6.0% to 6.3% in the placebo group over 12 weeks in phase 3 trials.
The mechanism of action involves tapinarof activating aryl hydrocarbon receptors, which help regulate immune response and maintain skin health, although some patients experienced mild adverse effects like folliculitis and headaches.
VTAMA&#174; (Tapinarof) Cream* for Plaque Psoriasis.Gupta, AK., Ravi, SP., Vincent, K., et al.[2022]

References

A Review of Tapinarof: Novel Topical Treatment for Plaque Psoriasis in Adults. [2023]
Tapinarof for the treatment of psoriasis. [2023]
VTAMA&#174; (Tapinarof) Cream* for Plaque Psoriasis. [2022]
Benvitimod inhibits MCM6-meditated proliferation of keratinocytes by regulating the JAK/STAT3 pathway. [2023]
Tapinarof Cream 1%: First Approval. [2022]
Phase 3 Trials of Tapinarof Cream for Plaque Psoriasis. [2021]
A phase 2b, randomized clinical trial of tapinarof cream for the treatment of plaque psoriasis: Secondary efficacy and patient-reported outcomes. [2021]