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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining a cream called triamcinolone (a corticosteroid) with vitamin D3 can more effectively treat mild to moderate psoriasis. Psoriasis is a skin condition that causes red, itchy patches. Participants will initially use only the cream and will later be divided into two groups: one receiving vitamin D3 and the other a placebo—a harmless pill with no active ingredients. Ideal candidates for this trial are those with plaque psoriasis that affects their daily life. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

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.

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

Research shows that vitamin D analogues are generally safe, with mild skin irritation as the most common side effect. They are usually well-tolerated for psoriasis treatment. Triamcinolone, a topical corticosteroid, often reduces skin inflammation. However, prolonged use of strong corticosteroids like triamcinolone can sometimes thin the skin.

In this study, researchers will use triamcinolone cream with vitamin D3. Although this specific combination is still in early testing, vitamin D analogues have shown promise in safely improving psoriasis symptoms. Early studies mainly focus on understanding safety, so more research is needed to fully confirm these results. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using Triamcinolone combined with Vitamin D3 for psoriasis because it explores a new approach by integrating two different mechanisms. Triamcinolone is a corticosteroid that reduces inflammation, while Vitamin D3 plays a part in skin cell growth regulation and immune function. This combination might offer enhanced benefits by addressing multiple pathways involved in psoriasis, potentially improving skin health more effectively than treatments focusing solely on inflammation, like standard corticosteroids or biologics. Additionally, Vitamin D3's role in skin cell regulation could mean fewer side effects compared to more aggressive therapies.

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

Research shows that triamcinolone cream combined with vitamin D3 can help treat psoriasis. In this trial, one group of participants will receive Triamcinolone Cream with Vitamin D3, while another group will receive Triamcinolone Cream with a placebo. Triamcinolone reduces swelling and itching. Vitamin D3, when used with this cream, can improve skin conditions and is generally safe with few side effects. Studies have found that vitamin D enhances the effectiveness of triamcinolone. For example, a patient with severe psoriasis experienced significant improvement after using vitamin D. This combination leverages the strengths of both treatments to better manage psoriasis. ^{1 2 3 6 7}

Who Is on the Research Team?

Jeffrey B Travers, MD, PhD

Principal Investigator

Wright State University

Are You a Good Fit for This Trial?

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

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

Unable to understand/complete informed consent

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3508578/

Mechanisms of Action of Topical Corticosteroids in Psoriasis Vitamin D analogues and low-potency steroids in a cream base are indicated for psoriasis of the face or flexures [93].

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10564191/

Topical Therapy in Psoriasis - PMC - PubMed Central - NIH Vitamin D analogues are later entrants into the treatment of psoriasis. ... Disadvantages. Vitamin D analogues are relatively safe with few side effects.

3. aafp.org aafp.org/pubs/afp/issues/2022/0500/p558.html

Psoriasis: Update on Topical Therapy From the American ... Topical calcineurin inhibitors, vitamin D analogues, and tazarotene are effective and can limit chronic topical corticosteroid use. • When topical vitamin D ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04036188

Triamcinolone With Vitamin D Synergistic Efficacy in ... 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 ...

5. aafp.org aafp.org/pubs/afp/issues/1999/0215/p957.html

Topical Psoriasis Therapy Another patient with osteoporosis experienced dramatic improvement in severe psoriasis after receiving an oral form of vitamin D.

6. jaad.org jaad.org/article/S0190-9622(20)32288-X/fulltext

Joint AAD–NPF Guidelines of care for the management ... Vitamin D analogues are considered safe for the treatment of plaque psoriasis. No clinical or experimental evidence has been found relating ...

7. mayoclinic.org mayoclinic.org/diseases-conditions/psoriasis/diagnosis-treatment/drc-20355845

Psoriasis - Diagnosis and treatment Long-term use or overuse of strong corticosteroids can thin the skin. Over time, topical corticosteroids may stop working. Vitamin D analogues.