A Study to Investigate Efficacy and Safety of VTAMA (Tapinarof) Cream, 1% in Intertriginous Plaque Psoriasis

Recruiting at 6 trial locations

Overseen By Philip Brown, MD, JD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Dermavant Sciences, Inc.

Disqualifiers: Other psoriasis, Infections, Serious illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

34 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a special cream called VTAMA (tapinarof) on adults with a type of psoriasis that affects skin folds. Participants will use the cream once daily for a few months. The cream helps by calming the skin's immune response, reducing redness and scaling. Tapinarof cream, also known as VTAMA, is a newly approved topical agent for treating plaque psoriasis and has shown promising results in clinical trials.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that you cannot use any investigational products within 30 days before starting the trial. It's best to discuss your current medications with the study team.

What data supports the effectiveness of the drug VTAMA (tapinarof) Cream, 1%?

Research shows that VTAMA (tapinarof) Cream, 1% is effective for treating plaque psoriasis, with significant improvements seen in clinical trials. In these studies, 35.4% to 40.9% of patients achieved clear or almost clear skin compared to much lower rates in those using a placebo cream. ^{1 2 3 4 5}

How is VTAMA (tapinarof) cream different from other psoriasis treatments?

VTAMA (tapinarof) cream is unique because it is a non-steroidal topical treatment that works by activating aryl hydrocarbon receptors, which help regulate the immune response and maintain skin balance. Unlike some other treatments, it is applied once daily and has shown promising results in achieving clear or almost clear skin in a significant number of patients with plaque psoriasis. ^{1 2 4 5 6}

Research Team

Victoria Butners

Principal Investigator

Dermavant Sciences, Inc.

Eligibility Criteria

Inclusion Criteria

You have plaque psoriasis and have had stable lesions in the folds of your skin for at least 3 months prior to the study.

You are 18 or older, as of the date you agreed to the informed consent.

You must have a negative pregnancy test on the first day.

Exclusion Criteria

You do not have plaque psoriasis.

You have a skin or inflammatory condition, other than plaque psoriasis, that could make it hard to understand the study results.

You have a history of allergic reactions to the study product or any of its components, or any other medication that would prevent you from participating in the study as determined by the investigator or medical monitor.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive VTAMA (tapinarof) cream, 1% applied topically once daily for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• VTAMA (tapinarof) Cream, 1%

Participant Groups

Group I: VTAMA® (tapinarof) Cream 1% Experimental Treatment 1 Intervention

VTAMA® (tapinarof) Cream 1% applied topically once daily

Who Is Running the Clinical Trial?

Dermavant Sciences, Inc.

Lead Sponsor

Trials

9

Recruited

1,800+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

VTAMA® (Tapinarof) Cream* for Plaque Psoriasis. Gupta, AK., Ravi, SP., Vincent, K., et al.[2022]

Tapinarof cream 1% has been shown to be highly effective in treating plaque psoriasis, achieving complete disease clearance in 40.9% of patients after 52 weeks of treatment, with significant improvements in disease activity and quality of life.

The treatment was well tolerated, with mild to moderate side effects like folliculitis and contact dermatitis, leading to low rates of discontinuation, indicating its safety for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tapinarof Cream 1% Once Daily for the Treatment of Plaque Psoriasis: Case Photography of Clinical Outcomes from Three Phase 3 Trials. Desai, SR., Stein Gold, L., Cameron, MC., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Tapinarof: Novel Topical Treatment for Plaque Psoriasis in Adults. Kalabalik-Hoganson, J., Nogid, A., Frey, K.[2023]

In a phase 2b study involving adults with plaque psoriasis, tapinarof cream (0.5% and 1%) showed significant improvements in psoriasis severity compared to a vehicle, with up to 92% of patients achieving a 50% reduction in severity after 12 weeks.

Most side effects from tapinarof were mild or moderate, suggesting a favorable safety profile, and the treatment demonstrated early efficacy, with significant results seen as early as week 2 and maintained through week 16.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 2b, randomized clinical trial of tapinarof cream for the treatment of plaque psoriasis: Secondary efficacy and patient-reported outcomes. Stein Gold, L., Bhatia, N., Tallman, AM., et al.[2021]

Tapinarof cream 1% is a topical treatment that acts as an aryl hydrocarbon receptor (AhR) agonist, which plays a role in regulating immune responses in the skin, and it has been approved in the USA for treating plaque psoriasis in adults.

The cream is also being studied for its effectiveness in treating atopic dermatitis, indicating its potential as a versatile treatment for various skin conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tapinarof Cream 1%: First Approval. Keam, SJ.[2022]

Tapinarof cream 1% was found to be well tolerated in 376 healthy adults across four phase 1 trials, showing only a slight potential for very mild cumulative skin irritation after 21 days of daily use.

The cream demonstrated no evidence of sensitization, photosensitization, or phototoxicity, indicating it is a safe option for treating conditions like psoriasis and potentially atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dermal Safety of Tapinarof Cream 1%: Results From 4 Phase 1 Trials. Jett, J., McLaughlin, M., Wilson, T., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

VTAMA® (Tapinarof) Cream* for Plaque Psoriasis. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Tapinarof Cream 1% Once Daily for the Treatment of Plaque Psoriasis: Case Photography of Clinical Outcomes from Three Phase 3 Trials. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

A Review of Tapinarof: Novel Topical Treatment for Plaque Psoriasis in Adults. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

A phase 2b, randomized clinical trial of tapinarof cream for the treatment of plaque psoriasis: Secondary efficacy and patient-reported outcomes. [2021]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Tapinarof Cream 1%: First Approval. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Dermal Safety of Tapinarof Cream 1%: Results From 4 Phase 1 Trials. [2022]