VTAMA Cream for Psoriasis

No longer recruiting at 6 trial locations

Overseen By Philip Brown, MD, JD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Organon and Co

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness and safety of VTAMA (tapinarof) Cream, 1% for individuals with intertriginous plaque psoriasis. Intertriginous psoriasis causes red, scaly patches, especially in areas where skin rubs together, such as underarms or behind knees. Participants must have had stable intertriginous psoriasis for at least three months. The cream is applied once daily to assess its ability to reduce symptoms and improve skin condition. As a Phase 4 trial, this research aims to understand how this FDA-approved treatment benefits a broader range of patients.

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 is the safety track record for VTAMA (tapinarof) Cream, 1%?

Research shows that VTAMA (tapinarof) cream, 1%, is generally well-tolerated. Some users experience mild side effects, with the most common being upper respiratory infections and minor skin issues like inflamed hair follicles and skin irritation. These side effects occur in about 1% or more of users. Less commonly, some people experience itchiness or hives. Rarely, side effects lead to stopping the treatment, with skin irritation and inflamed hair follicles being the most frequent reasons, affecting around 2.8% to 2.9% of users. Overall, the cream's safety profile suggests it is safe for most people, but monitoring for any new symptoms is important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

VTAMA (tapinarof) Cream, 1% is unique because it offers a novel approach to treating intertriginous plaque psoriasis. Unlike standard treatments that often rely on steroids or biologics, VTAMA is a topical cream that harnesses a non-steroidal active ingredient, tapinarof, which is derived from natural bacteria and works by modulating the immune response to reduce inflammation. Researchers are excited about VTAMA because it provides an effective treatment without the side effects commonly associated with steroid creams, offering a potentially safer and more convenient option for patients.

What is the effectiveness track record for VTAMA (tapinarof) Cream, 1% in treating intertriginous psoriasis?

Research has shown that VTAMA (tapinarof) cream, 1%, effectively treats plaque psoriasis. One study found that patients using VTAMA were six times more likely to see improvement compared to those using a placebo, as early as four weeks into treatment. The cream has also shown promise in treating atopic dermatitis by reducing the severity of the condition and improving skin health. This evidence suggests that VTAMA cream can help manage symptoms and improve skin condition for people with similar skin issues. Other trials have already tested its safety and effectiveness, highlighting its potential benefits for patients. ^{6 7 8 9 10}

Who Is on the Research Team?

Victoria Butners

Principal Investigator

Dermavant Sciences, Inc.

Are You a Good Fit for This Trial?

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 must have a negative pregnancy test on the first day.

You are able to provide written permission for participation.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• VTAMA (tapinarof) Cream, 1%

How Is the Trial Designed?

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

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

Who Is Running the Clinical Trial?

Organon and Co

Lead Sponsor

Trials

492

Recruited

1,733,000+

Juan Camilo Arjona Ferreira

Organon and Co

Chief Medical Officer since 2023

MD

Kevin Ali

Organon and Co

Chief Executive Officer since 2021

MBA from Santa Clara University, BA from the University of California, Berkeley

Dermavant Sciences, Inc.

Lead Sponsor

Trials

9

Recruited

1,800+

Published Research Related to This Trial

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]

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]

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 (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 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]

Citations

1. vtamahcp.com vtamahcp.com/plaque-psoriasis/efficacy/

See Clinical Results for VTAMA® (tapinarof) cream, 1% 6x more adult patients with plaque psoriasis who received VTAMA cream achieved treatment success* vs vehicle, with significant results as early as week 4.2,5-7.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12494503/

Efficacy and Safety of Tapinarof for Atopic Dermatitis In conclusion, 1% tapinarof cream applied once daily for eight weeks reduced disease severity, improved clinical outcomes (IGA success, EASI-75 ...

3. jaad.org jaad.org/article/S0190-9622(24)00755-2/fulltext

Tapinarof cream 1% once daily: Significant efficacy in the ... Tapinarof cream 1% once daily: Significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age.

4. vtamahcp.com vtamahcp.com/atopic-dermatitis/long-term-results/

Long-term Study - VTAMA® (tapinarof) cream, 1% (50) The majority of patients achieved complete disease clearance on VTAMA cream. ~52% (n=378/728) of patients with atopic dermatitis either entered with or ...

5. organon.com organon.com/news/update-on-fda-review-of-vtama-tapinarof-cream-1-for-the-treatment-of-atopic-dermatitis-in-adults-and-children-2-years-of-age-and-older/

Update on FDA Review of VTAMA® (tapinarof) Cream, 1% ... The safety and effectiveness of VTAMA cream was evaluated in randomized, double-blind, vehicle-controlled trials, PSOARING-1 and 2 for plaque ...

6. vtamahcp.com vtamahcp.com/atopic-dermatitis/safety-profile/

Safety - VTAMA® (tapinarof) cream, 1% (50) Adverse Events: In atopic dermatitis, the most common adverse reactions (incidence ≥1%) were: upper respiratory tract infection, red raised bumps around the ...

7. webmd.com webmd.com/drugs/2/drug-184226/vtama-topical/details

Vtama (tapinarof): Uses, Side Effects, Interactions, Pictures, ... Find patient medical information for Vtama (tapinarof) on WebMD including its uses, side effects and safety, interactions, pictures, ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2024/215272s002lbl.pdf

VTAMA® cream - accessdata.fda.gov Adverse reactions leading to treatment discontinuation in >1% of subjects who received VTAMA cream were contact dermatitis (2.9%) and folliculitis. (2.8%). In ...

9. nationaleczema.org nationaleczema.org/faq-organon-vtama/

FAQ - Vtama® (tapinarof) Cream The most common adverse reactions from clinical trials (incidence greater than/equal to 1%) are upper or lower respiratory tract infections, folliculitis ( ...

10. drugs.com drugs.com/sfx/tapinarof-topical-side-effects.html

Tapinarof Topical Side Effects: Common, Severe, Long Term Very common (10% or more): Folliculitis (20%) · Common (1% to 10%): Contact dermatitis, pruritus, urticaria · Uncommon (0.1% to 1%): Drug eruption.