Triamcinolone + Vitamin D for Psoriasis

Overseen By Regulatory Specialist

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Wright State University

Must be taking: Triamcinolone cream

Must not be taking: Calcium supplements, Biologics

Disqualifiers: Unstable illness, Renal impairment, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

24 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop certain medications before starting. You must not be on systemic non-biologic therapy, phototherapy, or certain topical treatments for a specified period before the trial begins. Check with the trial team to see if your current medications are included in these categories.

What data supports the effectiveness of the drug Triamcinolone + Vitamin D for treating psoriasis?

Research shows that combining a corticosteroid (like Triamcinolone) with a Vitamin D analog can effectively treat psoriasis by reducing inflammation and regulating skin cell production. This combination therapy has been found to be more effective than using each component alone. ^{1 2 3 4 5}

How is the drug Triamcinolone + Vitamin D unique for treating psoriasis?

Triamcinolone combined with Vitamin D for psoriasis is unique because it combines a corticosteroid (Triamcinolone) with Vitamin D, potentially offering anti-inflammatory benefits while also promoting skin health, which may reduce irritation and improve treatment effectiveness compared to using these components separately. ^{5 6 7 8 9}

What is the purpose of this trial?

These studies are designed to assess the synergistic efficacy of topical 0.1% triamcinolone cream paired with 40,000 IU of oral vitamin D3 daily in treating mild to moderate psoriasis. The study is designed to have all subjects treated with triamcinolone cream (TAC) for 4 weeks, then will be randomized 1:1 into vitamin D3 or placebo for an additional 12 weeks. At that time, the study will become open-label and all subjects will be placed on (or continue) vitamin D3 for an additional 12 weeks. The study will take place over 28 weeks total.

Research Team

Jeffrey B Travers, MD, PhD

Principal Investigator

Wright State University

Eligibility Criteria

Adults with mild to severe plaque psoriasis can join this trial. They must not be on certain medications that affect blood ion balance, have taken calcium supplements recently, or have unstable illnesses. People with a history of kidney stones, parathyroid issues, osteoporosis, or who are using tanning beds cannot participate.

Inclusion Criteria

I have psoriasis covering 2% or more of my body.

Exclusion Criteria

Unable to understand/complete informed consent

I haven't taken any systemic non-biologic treatments in the last 28 days.

I haven't taken calcium supplements, except in multivitamins, for a month.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive triamcinolone cream for 4 weeks, followed by randomization to vitamin D3 or placebo for 12 weeks

16 weeks

Open-label extension

All participants receive vitamin D3 for an additional 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Triamcinolone
• Vitamin D3

Trial Overview The study tests if triamcinolone cream combined with high-dose vitamin D3 pills is more effective for psoriasis than the cream alone. Participants first use the cream for 4 weeks and then get either vitamin D3 or a placebo randomly for 12 weeks before all receive vitamin D3 for another 12 weeks.

Participant Groups

Group I: Triamcinolone Cream + Vitamin D3 Experimental Treatment 2 Interventions

This arm will continue to take Vitamin D3 at Week 16 to Week 28.

Group II: Triamcinolone Cream + Placebo Placebo Group 3 Interventions

Starting at Week 16, this arm will be given Vitamin D3 to take until Week 28.

Triamcinolone is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Kenalog for:

• Allergic rhinitis
• Asthma
• Atopic dermatitis
• Contact dermatitis
• Psoriasis
• Rheumatoid arthritis
• Osteoarthritis
• Bursitis
• Tendinitis

Approved in Canada as Aristocort for:

• Allergic rhinitis
• Asthma
• Atopic dermatitis
• Contact dermatitis
• Psoriasis
• Rheumatoid arthritis
• Osteoarthritis
• Bursitis
• Tendinitis

Approved in European Union as Triamcinolone acetonide for:

• Allergic rhinitis
• Asthma
• Atopic dermatitis
• Contact dermatitis
• Psoriasis
• Rheumatoid arthritis
• Osteoarthritis
• Bursitis
• Tendinitis

Who Is Running the Clinical Trial?

Wright State University

Lead Sponsor

Trials

47

Recruited

55,300+

Wright State Physicians

Lead Sponsor

Trials

4

Recruited

100+

Findings from Research

Fixed-dose combination therapy using calcipotriol (vitamin D analog) and betamethasone dipropionate (corticosteroid) is effective in treating psoriasis, showing superior results compared to individual treatments and traditional formulations like ointments and gels.

This combination therapy not only enhances efficacy through improved skin penetration and immunomodulation but also offers a favorable safety profile by mitigating the risks associated with each component, suggesting potential for long-term management of psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing Anti-Inflammatory and Immunomodulatory Effects of Corticosteroid and Vitamin D Analogue Fixed-Dose Combination Therapy. Segaert, S., Shear, NH., Chiricozzi, A., et al.[2020]

In a study involving 885 patients with scalp psoriasis, a maintenance strategy of applying a calcipotriol and betamethasone dipropionate formulation twice a week was found to be more effective than on-demand therapy.

Patients using the twice-weekly application showed significantly better clinical improvement and a lower rate of relapse compared to those using the on-demand approach, particularly noted at weeks 8 and 12 of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and maintenance strategies of two-compound formulation calcipotriol and betamethasone dipropionate gel (Xamiol® gel) in the treatment of scalp psoriasis: results from a study in 885 patients. Saraceno, R., Camplone, G., D'Agostino, M., et al.[2022]

Long-term treatment with the combination of calcipotriol and betamethasone dipropionate is effective and well tolerated for up to 1 year when used as needed, and for up to 16 weeks on a fixed regimen, based on a systematic review of 37 studies including 28 randomized controlled trials.

Calcipotriol alone is also effective and well tolerated for long-term use (up to 52 weeks as needed and 20 weeks on a fixed regimen), but the combination therapy shows a more favorable safety and efficacy profile, highlighting the importance of regular consultations between patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review and practical guidance on the use of topical calcipotriol and topical calcipotriol with betamethasone dipropionate as long-term therapy for mild-to-moderate plaque psoriasis. Zhao, Y., Asahina, A., Asawanonda, P., et al.[2021]

Topical corticosteroids, especially very potent ones, are more effective than other treatments like vitamin D₃ analogues for managing scalp psoriasis.

This finding suggests that using a strong topical corticosteroid may provide better relief for patients suffering from this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Help Desk Answers: What's the most effective topical Tx for scalp psoriasis? Thomas, SK., Hamilton, T.[2018]

In a 4-week study involving 410 adult psoriasis patients, the aerosol foam of calcipotriol and betamethasone (Cal/BD foam) demonstrated significant efficacy, with 49% of patients achieving clear or almost clear skin after treatment.

The treatment was well-tolerated, with 93% of patients reporting no adverse events, indicating it is a safe option for managing psoriasis, especially in those with more severe cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective, Observational, Non-Interventional, Multicentre Study on the Efficacy and Tolerability of a New Calcipotriol/Betamethasone Aerosol Foam (Enstilar®) in Patients with Plaque Psoriasis under Daily Practice Conditions. Gerdes, S., Krakor, M., Anger, T., et al.[2018]

In a study involving 45 subjects over 4 weeks, the skin thinning caused by Daivobet ointment was found to be equal to or less than that caused by Diprosone, indicating similar atrophogenic potential.

No clinical signs of skin irritation or atrophy were observed in either treatment group, suggesting that Daivobet is a safe option for psoriasis treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The atrophogenic potential and dermal tolerance of calcipotriol/betamethasone dipropionate ointment compared with betamethasone dipropionate ointment. Traulsen, J., Hughes-Formella, BJ.[2017]

In a study involving 61 patients with stable plaque psoriasis, the combination treatment of calcipotriol and clobetasol propionate was found to be more effective than calcipotriol alone, with more patients achieving at least a 50% reduction in their eruption score after 2 weeks.

The combination treatment not only resulted in a lower eruption score after 6 weeks but also had fewer adverse effects, making it a promising option for long-term management of psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination of calcipotriol and clobetasol propionate as a premixed ointment for the treatment of psoriasis. Katoh, N., Kishimoto, S.[2014]

Dovobet ointment, which combines calcipotriol and betamethasone dipropionate, enhances the effectiveness of psoriasis treatment by allowing for a single application of both medications.

This formulation not only improves therapeutic activity but also reduces skin irritation caused by calcipotriol without increasing the risk of skin thinning associated with corticosteroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The calcipotriol-betamethasone dipropionate association]. Henry, F., Flagothier, C., Delvoye, P., et al.[2015]

Topical treatments for psoriasis, including corticosteroids and vitamin D analogues, are commonly used and can be more effective when combined with each other or with UV light and systemic drugs.

The combination of calcipotriol (a vitamin D analogue) with corticosteroids is frequently prescribed for mild to moderate psoriasis, and this approach can enhance treatment effectiveness and tolerability, especially in severe cases requiring systemic therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Topical treatment of psoriasis: a systematic update]. Aschoff, R., Wozel, G., Meurer, M.[2018]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Optimizing Anti-Inflammatory and Immunomodulatory Effects of Corticosteroid and Vitamin D Analogue Fixed-Dose Combination Therapy. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy and maintenance strategies of two-compound formulation calcipotriol and betamethasone dipropionate gel (Xamiol® gel) in the treatment of scalp psoriasis: results from a study in 885 patients. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Systematic review and practical guidance on the use of topical calcipotriol and topical calcipotriol with betamethasone dipropionate as long-term therapy for mild-to-moderate plaque psoriasis. [2021]

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

Help Desk Answers: What's the most effective topical Tx for scalp psoriasis? [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Prospective, Observational, Non-Interventional, Multicentre Study on the Efficacy and Tolerability of a New Calcipotriol/Betamethasone Aerosol Foam (Enstilar®) in Patients with Plaque Psoriasis under Daily Practice Conditions. [2018]

6. Switzerland pubmed.ncbi.nlm.nih.gov

The atrophogenic potential and dermal tolerance of calcipotriol/betamethasone dipropionate ointment compared with betamethasone dipropionate ointment. [2017]

7. France pubmed.ncbi.nlm.nih.gov

Combination of calcipotriol and clobetasol propionate as a premixed ointment for the treatment of psoriasis. [2014]

8. Belgium pubmed.ncbi.nlm.nih.gov

[The calcipotriol-betamethasone dipropionate association]. [2015]

9. Germany pubmed.ncbi.nlm.nih.gov

[Topical treatment of psoriasis: a systematic update]. [2018]