Triamcinolone + Vitamin D for Psoriasis
Recruiting in Palo Alto (17 mi)
Overseen byJeffrey B Travers, MD, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
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
Trial Summary
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.
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.
12345How 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.
56789Eligibility 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.
I am 18 years old or older.
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.
+12 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Triamcinolone Cream + Vitamin D3Experimental Treatment2 Interventions
This arm will continue to take Vitamin D3 at Week 16 to Week 28.
Group II: Triamcinolone Cream + PlaceboPlacebo Group3 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Wright State PhysiciansFairborn, OH
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Who Is Running the Clinical Trial?
Wright State UniversityLead Sponsor
Wright State PhysiciansLead Sponsor
References
Optimizing Anti-Inflammatory and Immunomodulatory Effects of Corticosteroid and Vitamin D Analogue Fixed-Dose Combination Therapy. [2020]Fixed-dose combination topical therapy with corticosteroid and vitamin D analog provides effective treatment and possible long-term management of psoriasis. The anti-inflammatory and immunomodulatory effects of corticosteroids and vitamin D analogs in treating psoriasis are well investigated; their complementary effects lead to the disruption of the inflammatory feedback loop underlying psoriasis pathogenesis. Recent preclinical data showed that combination therapy is more effective than monotherapies of the active ingredients in preventing activation of resting pro-inflammatory cells, inducing immunomodulation, reducing inflammatory responses by regulating T cell production, and normalizing keratinocytes. The increased understanding of the mechanism of action of fixed-dose combination therapy from preclinical studies is supported by several clinical studies. As the efficacy of topical therapy is correlated with the skin penetration of the active ingredients, new drug delivery systems have been developed. The fixed-dose combination Cal/BD aerosol foam creates a modified supersaturated formulation when applied to the skin, which is maintained for at least 26 h in the laboratory setting. Clinical studies have demonstrated superior efficacy of fixed-dose combination calcipotriol (Cal) 50 µg/g and betamethasone dipropionate (BD) 0.5 mg/g aerosol foam compared with monotherapies of the active ingredients. Furthermore, Cal/BD aerosol foam has shown significantly improved efficacy compared with more traditional formulations, such as Cal/BD ointment and gel, in other studies. Calcipotriol also mitigates risks associated with betamethasone dipropionate and vice versa, resulting in the favorable safety profile observed with fixed-dose combination treatment. Recent data also suggest that fixed-dose combination treatment could provide long-term management of psoriasis, although further clinical investigations are needed. Overall, these data support the value of fixed-dose combination therapy of corticosteroid and vitamin D analog and highlight the added potential of innovative drug delivery for the treatment of psoriasis.
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]Previous studies showed the efficacy of a formulation containing calcipotriol and betamethasone dipropionate for the treatment of psoriasis.
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]While many patients with psoriasis are candidates for topical agents, long-term treatment effects are unclear. This systematic review evaluated global findings from clinical trials and real-world studies of topical calcipotriol and the two-compound formulation of calcipotriol and betamethasone dipropionate for mild-to-moderate plaque psoriasis (including scalp psoriasis). PubMed, Embase and MEDLINE were searched for relevant English-language publications along with Chinese, Japanese, Korean and Latin American publication databases. Identified articles were screened by title and abstract against predefined inclusion/exclusion criteria. A narrative synthesis of key efficacy and safety findings from the full papers of selected publications was developed. Thirty-seven relevant papers were identified (25 English, 11 Chinese and one Japanese-language study) including 28 randomized controlled trials. While there was significant heterogeneity in study length, treatment intensity and clinical measures, following a critical review of the published data combined with expert opinion, the following clinical practice recommendations were agreed in order to assist healthcare providers: in adults, long-term treatment with calcipotriol/betamethasone dipropionate is well tolerated and efficacious for up to 1 year on an 'as needed' basis, and for up to 16 weeks on a fixed-treatment regimen. Calcipotriol is also well tolerated and efficacious when used long term (up to 52 weeks) 'as needed' and for up to 20 weeks on a fixed-treatment regimen. Used on an 'as needed' basis for up to 1 year, the safety and efficacy profile of fixed-dose combination calcipotriol/betamethasone dipropionate is more favorable than calcipotriol alone; regular consultation between patients and their dermatologist/primary care physician is required to review psoriasis symptoms and adjust treatment accordingly; a specific treatment goal should be agreed on initiation of topical agent(s) to determine when long-term treatment can begin or if a regimen change is warranted; and application frequency during the continued treatment phase should consider the patients' treatment expectations and goals.
Help Desk Answers: What's the most effective topical Tx for scalp psoriasis? [2018]Single-agent therapy with a very potent or potent topical corticosteroid appears more effective than other topical agents, including vitamin D₃ analogues, for treating scalp psoriasis.
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]To assess the efficacy and tolerability of the new aerosol foam of calcipotriol 50 µg/g plus betamethasone dipropionate 0.5 mg/g (Cal/BD foam, Enstilar®) in psoriasis vulgaris under daily practice conditions.
The atrophogenic potential and dermal tolerance of calcipotriol/betamethasone dipropionate ointment compared with betamethasone dipropionate ointment. [2017]Recently, a combination product (Daivobet) ointment: calcipotriol 50 micro g/g, betamethasone dipropionate 0.5 mg/g) has been developed for the treatment of psoriasis.
Combination of calcipotriol and clobetasol propionate as a premixed ointment for the treatment of psoriasis. [2014]The treatment of psoriasis requires good compliance, efficacy and low toxicity because of its long-term course and wide distribution. The aim of the study was to compare the efficacy of a once daily application of calcipotriol alone or calcipotriol and a superpotent steroid in a premixed form in patients with psoriasis. The monotherapy group of 32 patients with stable plaque psoriasis received 0.005% calcipotriol alone once daily. The combination group of 29 patients was treated once per day with 0.004% calcipotriol/0.01% clobetasol propionate as a premixed ointment. Eruption score of truncal involvement was evaluated. The combination regimen was more efficacious than the monotherapy as evidenced by (1) more patients with at least 50% reduction in the eruption score after 2 weeks, (2) lower eruption score after 6 weeks and later, and (3) less adverse effects. The combined once-per-day application of 0.004% calcipotriol/0.01% clobetasol propionate as a premixed ointment is a promising regimen for psoriasis.
[The calcipotriol-betamethasone dipropionate association]. [2015]The topical treatment of psoriasis benefits from the alternate use of dermocorticosteroids and vitamin D3 analogues. A new galenic formulation allows to combine them in a single application. Dovobet (LEO Pharma) ointment is the association of calcipotriol 50 microg/g with betamethasone dipoprionate 0.5 mg/g. This formulation boosts the therapeutic activity of calcipotriol. It also decreases the irritative inflammatory reaction due to calcipotriol without increasing the atrophogenic risk of the dermocorticoid.
[Topical treatment of psoriasis: a systematic update]. [2018]Classical topical treatment regimens in psoriasis including dithranol and corticosteroids are widely used and have been supplemented in recent years by topical vitamin D preparations, by vitamin D analogues and topical retinoids. The combination of these preparations with each other, with UV light or with systemic drugs often lead to improved effectiveness and tolerability when compared with the respective monotherapy. In private offices, the combination of calcipotriol with various corticosteroids is very commonly prescribed for patients with mild to moderate psoriasis. This combination can be sequentially applied twice daily or--in a newly introduced fixed preparation--once daily. In severe psoriasis requiring systemic treatment a concomitant effective topical treatment regimen can greatly improve the overall longtime management in affected patients.