Betamethasone vs. Tapinarof for Psoriasis

Overseen By Irma M Richardson, MHA

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Wake Forest University Health Sciences

Disqualifiers: No psoriasis, Skin type below 3, 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: 6

Duration: Up to 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two psoriasis treatments, betamethasone cream (a corticosteroid) and tapinarof cream (a topical treatment), to assess their effects on skin pigmentation changes on the legs. The goal is to determine which treatment causes less discoloration after treating psoriasis inflammation. Participants will be randomly assigned to use one of these creams once daily for up to 12 weeks. This trial suits adults with skin type 3 or higher who have stable psoriasis and have been on other therapies for at least three months. As a Phase 2, Phase 3 trial, this research measures the treatments' effectiveness in an initial group and represents the final step before FDA approval, offering participants a chance to contribute to potential new therapies.

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 requires that you have been stable on other therapies, like biologics, for at least 3 months before joining.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both betamethasone cream and tapinarof cream are generally safe and effective for treating psoriasis.

Betamethasone cream works well for mild to moderate plaque psoriasis, though about 34% of users reported mild side effects. Its safety for children remains unconfirmed.

Tapinarof cream also proves safe and effective, helping many improve their psoriasis. Research found it can be used safely for up to a year, with many users achieving clearer skin.

In summary, both treatments are considered safe based on studies, but participants should be aware of possible mild side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for psoriasis, like corticosteroids, work by reducing inflammation and suppressing the immune response. But Tapinarof works differently, targeting the aryl hydrocarbon receptor (AhR) pathway, which helps modulate immune responses and skin cell growth. Researchers are excited about Tapinarof because it offers a novel mechanism of action, which could provide an alternative for patients who don't respond well to traditional therapies. Additionally, Tapinarof is a non-steroidal topical treatment, potentially reducing the risk of side effects associated with long-term steroid use.

What evidence suggests that this trial's treatments could be effective for psoriasis?

This trial will compare Betamethasone dipropionate 0.05% cream with Tapinarof cream 1% for treating psoriasis. Research has shown that Betamethasone dipropionate 0.05% cream is a safe and highly effective treatment, with studies finding that daily use can greatly reduce symptoms. Tapinarof cream 1% has also proven very effective for psoriasis. Clinical trials indicate that Tapinarof can significantly improve skin condition, with up to 48% of patients experiencing a noticeable reduction in psoriasis severity by week 12. Both treatments show promise in managing psoriasis and improving skin health. ^{6 7 8 9 10}

Who Is on the Research Team?

Steven Feldman, MD, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a certain skin type (Fitzpatrick skin type 3 or higher) who have been diagnosed with psoriasis. They must be stable on other treatments like biologics for at least three months before the study starts. People without this diagnosis or those with pigmentary changes that could affect outcome assessment cannot participate.

Inclusion Criteria

I am an adult with a medium to dark skin tone, diagnosed with psoriasis.

I have been on the same biologic treatment for at least 3 months.

Exclusion Criteria

I do not have psoriasis and my skin type is 3 or above.

You have skin changes that could make it hard to evaluate the study results.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either betamethasone dipropionate 0.05% cream or 1% tapinarof cream applied once daily to both legs until clear or up to 12 weeks

Up to 12 weeks

Visits every 4 weeks

Follow-up

Participants are monitored for PIPA and other after-treatment effects

4 weeks

2 visits (at 1 and 4 weeks post-treatment)

What Are the Treatments Tested in This Trial?

Interventions

• Betamethasone dipropionate 0.05% cream
• Tapinarof

Trial Overview The study compares two psoriasis treatments: Betamethasone dipropionate, a strong steroid cream, and Tapinarof, which works by targeting inflammation pathways. Participants will randomly receive one treatment to see how each affects skin pigmentation after inflammation.

How Is the Trial Designed?

Group I: Betamethasone dipropionate 0.05% Active Control 1 Intervention

The betamethasone dipropionate 0.05% cream group will be treated with betamethasone dipropionate 0.05% cream once daily on both legs until clear or up to 12 weeks.

Group II: Tapinarof Active Control 1 Intervention

The tapinarof group will be treated with 1% tapinarof cream applied once daily to both legs until clear or up to 12 weeks.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Dermavant Sciences, Inc.

Industry Sponsor

Trials

9

Recruited

1,800+

Published Research Related to This Trial

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, 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, 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tapinarof for the treatment of psoriasis. Nogueira, S., Rodrigues, MA., Vender, R., et al.[2023]

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% 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]

Citations

1. mdpi.com mdpi.com/2077-0383/13/15/4484

Calcipotriol/Betamethasone Dipropionate for the Treatment ... The combination therapy demonstrated significantly greater efficacy than BPD in the reduction of the total sign score after two weeks and at 8 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5049671/

Real‐life effectiveness of once‐daily calcipotriol and ... At week 52, a higher proportion of patients reported that the severity of their psoriasis was 'mild'/'very mild' vs. baseline (gel: 60.2 vs. 47.1%; ointment: ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0190962200175747

Topical therapy for psoriasis with the use of augmented ... The study had power of 93.7%. No patient had skin irritation. Conclusion: Use of augmented betamethasone and calcipotriene on alternate weeks is more effective ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/2649319/

0.05 percent betamethasone dipropionate in optimized ... We conclude that the cream is a safe and highly effective treatment for psoriasis. The once-a-day application is probably adequate for control of psoriasis.

5. jcadonline.com jcadonline.com/betamethasone-dipropionate-spray-plaque-psoriasis/

Efficacy, Safety, and Potency of Betamethasone ... Conclusions: BD spray 0.05%, a midpotent corticosteroid, is an effective and well-tolerated treatment for adults with mild to moderate plaque psoriasis.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5891082/

Efficacy, Safety, and Potency of Betamethasone ... BD spray 0.05%, a midpotent corticosteroid, is an effective and well-tolerated treatment for adults with mild to moderate plaque psoriasis.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2790732/

A Study of the Safety and Efficacy of Calcipotriol ... This two-compound ointment has both good safety and efficacy profiles in the short- and long-term management of psoriasis vulgaris of the trunk and limbs, ...

8. sciencedirect.com sciencedirect.com/science/article/pii/0149291895801049

Efficacy and safety of twice-daily augmented ... Adverse events were reported by 34.0% and 36.4% of patients receiving betamethasone dipropionate and clobetasol propionate, respectively. All events were ...

9. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2016/208079Orig1s000ClinPharmR.pdf

208079Orig1s000 The clinical study data for Betamethasone Dipropionate Spray, 0.05% consist of ten clinical trials with Betamethasone Dipropionate Spray, 0.05% ...

10. mayoclinic.org mayoclinic.org/drugs-supplements/betamethasone-dipropionate-topical-application-route/description/drg-20073667

Betamethasone dipropionate (topical application route) Safety and efficacy have not been established. Use is not recommended in children.