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Last Updated: February 15, 2025

CLINICAL TRIALS PROFILE FOR CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE


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All Clinical Trials for Calcipotriene And Betamethasone Dipropionate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00279162 ↗ Efficacy and Safety of Calcipotriene/Betamethasone Gel/Ointment in Psoriasis Completed LEO Pharma Phase 3 2005-12-01 Patients will receive either a gel containing both calcipotriene plus betamethasone or gel with no active ingredients as treatment for their scalp psoriasis for 8 weeks. After this time all patients will receive the gel containing both calcipotriene and betamethasone for 44 weeks. In addition, patients will receive an ointment containing both calcipotriene plus betamethasone as treatment for their psoriasis of the trunk and limbs for 52 weeks. The objective is to study the short-term efficacy of the gel, and the short and long-term safety of the gel and the ointment.
NCT00437255 ↗ Efficacy, Safety, Preference and Response Duration of Clobex® Spray and Taclonex® Ointment in Psoriasis Completed Galderma Laboratories, L.P. Phase 4 2006-08-01 Evaluate the efficacy of Clobex® Spray as compared to Taclonex® Ointment in terms of Overall Disease Severity and Investigator Global Assessment.
NCT00817219 ↗ Safety and Efficacy of TACLONEX Ointment in Adolescent Patients (Aged 12 to 17 Years) With Psoriasis Vulgaris Completed LEO Pharma Phase 2 2009-07-01 The purpose of this study is to evaluate the safety and efficacy of 4 weeks of TACLONEX ointment in adolescent patients with psoriasis vulgaris.
NCT01707043 ↗ Patient Preference of Taclonex Ointment to Taclonex Scalp Suspension in Adult Subjects With Psoriasis Vulgaris Completed LEO Pharma Phase 4 2012-10-01 This is an open label, investigator-blinded, cross over, prospective, single center study of subjects with plaque psoriasis. Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment and Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension will each be applied topically once daily. The primary objective is to assess the patient preference for Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment compared to Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension in the treatment of plaque psoriasis.
NCT01707043 ↗ Patient Preference of Taclonex Ointment to Taclonex Scalp Suspension in Adult Subjects With Psoriasis Vulgaris Completed Wake Forest University Phase 4 2012-10-01 This is an open label, investigator-blinded, cross over, prospective, single center study of subjects with plaque psoriasis. Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment and Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension will each be applied topically once daily. The primary objective is to assess the patient preference for Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment compared to Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension in the treatment of plaque psoriasis.
NCT01761019 ↗ A Study to Determine the Efficacy of Taclonex Topical Suspension as a Supplement to Non-biologic Systemic Therapy Completed LEO Pharma Phase 4 2013-01-01 Oral therapies for psoriasis, including methotrexate and acitretin, are often less effective when used as monotherapy (without other oral medicines or creams) than are newer biologic injected drugs. However, these oral medications are also less expensive than biologic agents and may be safer for use in some patients. The purpose of this study is to determine if adding a topical psoriasis medicine, calcipotriene/betamethasone topical suspension (Taclonex topical suspension), will improve the severity of psoriasis in patients already on methotrexate or acitretin and to determine if adding this topical suspension will reduce the desire of such patients to switch to a biologic agent to treat their psoriasis.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Calcipotriene And Betamethasone Dipropionate

Condition Name

Condition Name for Calcipotriene And Betamethasone Dipropionate
Intervention Trials
Psoriasis 7
Plaque Psoriasis 4
Psoriasis Vulgaris 3
Scalp Psoriasis 2
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Condition MeSH

Condition MeSH for Calcipotriene And Betamethasone Dipropionate
Intervention Trials
Psoriasis 16
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Clinical Trial Locations for Calcipotriene And Betamethasone Dipropionate

Trials by Country

Trials by Country for Calcipotriene And Betamethasone Dipropionate
Location Trials
United States 66
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Trials by US State

Trials by US State for Calcipotriene And Betamethasone Dipropionate
Location Trials
Texas 7
Florida 5
New Jersey 4
North Carolina 4
Virginia 4
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Clinical Trial Progress for Calcipotriene And Betamethasone Dipropionate

Clinical Trial Phase

Clinical Trial Phase for Calcipotriene And Betamethasone Dipropionate
Clinical Trial Phase Trials
Phase 4 9
Phase 3 3
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Calcipotriene And Betamethasone Dipropionate
Clinical Trial Phase Trials
Completed 12
Unknown status 2
Not yet recruiting 1
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Clinical Trial Sponsors for Calcipotriene And Betamethasone Dipropionate

Sponsor Name

Sponsor Name for Calcipotriene And Betamethasone Dipropionate
Sponsor Trials
LEO Pharma 6
Psoriasis Treatment Center of Central New Jersey 4
Glenmark Pharmaceuticals Ltd. India 2
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Sponsor Type

Sponsor Type for Calcipotriene And Betamethasone Dipropionate
Sponsor Trials
Industry 17
Other 8
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Calcipotriene and Betamethasone Dipropionate: Clinical Trials, Market Analysis, and Projections

Introduction to Calcipotriene and Betamethasone Dipropionate

Calcipotriene and betamethasone dipropionate are two active ingredients commonly combined in topical formulations for the treatment of psoriasis, a chronic inflammatory skin disorder. This combination therapy has been widely studied and is available in various forms, including ointments, foams, and creams.

Clinical Trials Overview

Efficacy in Psoriasis Treatment

Clinical trials have consistently shown that the combination of calcipotriene and betamethasone dipropionate is more effective than using either ingredient alone. In a randomized Phase III study, the calcipotriol/betamethasone foam formulation (Enstilar) demonstrated significant efficacy in treating psoriasis vulgaris. The study found that 45% of patients achieved treatment success according to the Investigator’s Global Assessment of Disease Severity (IGA), compared to 30.7% for betamethasone dipropionate alone and 14.9% for calcipotriol alone[4].

Another key finding was the rapid reduction in itch and itch-related sleep loss. A statistically significant number of patients in the calcipotriol/betamethasone group achieved a 70% reduction in itch from day 3 onwards[4].

Scalp Psoriasis Treatment

The efficacy of calcipotriol/betamethasone foam was also evaluated in the treatment of scalp psoriasis. The results showed that 53% of patients in the calcipotriol/betamethasone foam group achieved treatment success according to the Physician’s Global Assessment (PGA) of the scalp at Week 4, which was higher than the rates for betamethasone dipropionate and calcipotriol alone[4].

Safety Profile

The safety profile of calcipotriene and betamethasone dipropionate has been evaluated in several clinical studies. The most common adverse effects associated with the use of this combination include those typical of topical corticosteroids and vitamin D analogs, such as skin irritation and pruritus. However, these adverse effects are generally mild and transient[4].

Market Analysis

Current Market Presence

The combination of calcipotriene and betamethasone dipropionate is widely available in the market in various formulations. The aerosol foam formulation (Enstilar) by LEO Pharma is well-established and has been shown to be effective, safe, and cost-effective for managing psoriasis beyond mild cases[5].

New Formulations

A newer formulation, Wynzora Cream by EPI Health/MC2 Therapeutics, features a specialized multimolecular technology (Polyaphron Dispersion [PAD™] Technology) that encapsulates the active ingredients in microscopic oil droplets. Clinical trials have shown that this cream formulation outperformed the topical suspension in terms of Physicians Global Assessment (PGA) and mean psoriasis area and severity index (PASI) improvement at week 8[5].

Patient Preference

Patient preference studies have indicated that patients find the cream formulation more convenient than the topical suspension. A pilot study comparing patient satisfaction between calcipotriene and betamethasone dipropionate foam and cream formulations found that patients preferred the cream due to its convenience and ease of use[5].

Cost-Utility Analysis

Economic Impact

A cost-utility analysis from a Swedish healthcare payer's perspective revealed that the calcipotriol/betamethasone dipropionate foam formulation, despite being more expensive than the ointment, is more cost-effective. This is due to its increased efficacy, which results in fewer consultations and a decreased risk of progressing to more costly treatments like phototherapy or methotrexate[2].

Long-Term Cost Savings

The analysis showed that the base-case net monetary benefit of using the foam formulation was robust to plausible variations in key parameters. This suggests that the long-term cost savings associated with reduced need for additional treatments and consultations can offset the higher initial cost of the foam formulation[2].

Market Projections

Global Market Outlook

The global market for plaque psoriasis treatments is expected to grow significantly over the next decade. Key events driving this growth include the launch of new treatments such as Wynzora (calcipotriene + betamethasone dipropionate), Bimzelx (bimekizumab), Deucravacitinib, Roflumilast, and Tapinarof[3].

Regional Outlook

The market is expected to expand across various regions, including North America, Europe, Latin America, the Middle East, Africa, and the Asia-Pacific region. The increasing prevalence of psoriasis and the introduction of new, more effective treatments are driving this growth[3].

Key Takeaways

  • Efficacy: Calcipotriene and betamethasone dipropionate combination therapy is significantly more effective than monotherapy in treating psoriasis.
  • Safety: The combination has a favorable safety profile with mild and transient adverse effects.
  • Patient Preference: Patients prefer the cream formulation due to its convenience and ease of use.
  • Cost-Effectiveness: The foam formulation is more cost-effective despite higher initial costs due to reduced need for additional treatments.
  • Market Growth: The global market for plaque psoriasis treatments is expected to grow, driven by new treatment launches and increasing prevalence.

FAQs

Q: What are the common formulations of calcipotriene and betamethasone dipropionate?

A: The common formulations include ointments, foams (e.g., Enstilar), and creams (e.g., Wynzora).

Q: How effective is the combination therapy in treating psoriasis?

A: Clinical trials have shown that the combination is significantly more effective than using either ingredient alone, with up to 45% of patients achieving treatment success according to the IGA[4].

Q: What are the most common adverse effects associated with this combination?

A: The most common adverse effects include skin irritation and pruritus, which are generally mild and transient[4].

Q: Is the foam formulation more cost-effective than the ointment?

A: Yes, despite being more expensive, the foam formulation is more cost-effective due to its increased efficacy and reduced need for additional treatments[2].

Q: What is the market outlook for plaque psoriasis treatments?

A: The market is expected to grow significantly over the next decade, driven by new treatment launches and increasing prevalence of psoriasis[3].

Sources

  1. FDA Clinical Review: "N22-185S018 Calcipotriene and Betamethasone dipropionate Clinical PREA" - FDA.
  2. Cost-Utility Analysis: "A Cost-utility Analysis of Calcipotriol/Betamethasone Dipropionate Foam and Ointment in Psoriasis Vulgaris" - PubMed.
  3. Market Analysis: "Plaque Psoriasis in 68 Markets - Disease Overview, Product Profiles" - GlobalData.
  4. Clinical Trial Evidence: "Key clinical-trial evidence for calcipotriol/ betamethasone foam in patients with psoriasis vulgaris" - DermNet.
  5. Patient Preference Study: "Patient Preference for Calcipotriene and Betamethasone Dipropionate Cream Versus Foam for the Topical Treatment of Psoriasis: A Pilot Study" - Journal of Dermatological Treatment.

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