CLINICAL TRIALS PROFILE FOR BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE

All Clinical Trials for Betamethasone Dipropionate; Calcipotriene

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.
NCT01761019 ↗	A Study to Determine the Efficacy of Taclonex Topical Suspension as a Supplement to Non-biologic Systemic Therapy	Completed	University of Pittsburgh	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.

Clinical Trial Conditions for Betamethasone Dipropionate; Calcipotriene

Condition Name

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

Condition MeSH

Condition MeSH for Betamethasone Dipropionate; Calcipotriene
Intervention	Trials
Psoriasis	16

Clinical Trial Locations for Betamethasone Dipropionate; Calcipotriene

Trials by Country

Trials by Country for Betamethasone Dipropionate; Calcipotriene
Location	Trials
United States	66

Trials by US State

Trials by US State for Betamethasone Dipropionate; Calcipotriene
Location	Trials
Texas	7
Florida	5
New Jersey	4
North Carolina	4
Virginia	4

Clinical Trial Progress for Betamethasone Dipropionate; Calcipotriene

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for Betamethasone Dipropionate; Calcipotriene
Clinical Trial Phase	Trials
Completed	12
Unknown status	2
Recruiting	1

Clinical Trial Sponsors for Betamethasone Dipropionate; Calcipotriene

Sponsor Name

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

Sponsor Type

Sponsor Type for Betamethasone Dipropionate; Calcipotriene
Sponsor	Trials
Industry	17
Other	8

Clinical Trials, Market Analysis, and Projections for Betamethasone Dipropionate and Calcipotriene

Introduction to Betamethasone Dipropionate and Calcipotriene

Betamethasone dipropionate and calcipotriene are two active ingredients commonly combined in topical formulations for the treatment of psoriasis, a chronic inflammatory skin condition. This combination leverages the anti-inflammatory properties of betamethasone, a corticosteroid, and the vitamin D analog properties of calcipotriene, which helps regulate skin cell growth.

Clinical Trials Overview

Phase 3 Trials

Recent Phase 3 trials have demonstrated the efficacy and safety of the combination cream of betamethasone dipropionate and calcipotriene. A notable trial conducted in the European Union compared Wynzora cream (a formulation using PAD Technology) with Daivobet gel. The results showed that Wynzora cream achieved a Physician Global Assessment (PGA) treatment success rate of 52% and a 68% reduction in the modified Psoriasis Area and Severity Index (mPASI) at week 4, significantly outperforming Daivobet gel[1][4].

Patient-Reported Outcomes

Patient-reported outcomes were also favorable, with patients reporting high treatment convenience at weeks 4 and 8, and an improvement in the dermatology life quality index at the same time points. These results highlight the cream's effectiveness in both clinical and real-world settings[1].

Safety Profile

The safety profile of the combination cream has been favorable, with trials indicating a low incidence of adverse effects. For instance, uncontrolled clinical trials (MBL 0801 and MBL 0412) supported the short-term safety of the topical suspension, although these trials were not designed to draw statistical conclusions about efficacy[3].

Market Analysis

Market Impact

The introduction of betamethasone dipropionate and calcipotriene formulations, particularly the cream and foam versions, has significant implications for the psoriasis treatment market. A budget impact model developed for a hypothetical US healthcare plan estimated that the adoption of calcipotriene and betamethasone dipropionate foam could reduce the overall cost of treatment by lowering the need for biologics and other costly therapies[2].

Cost-Utility Analysis

A cost-utility analysis from a Swedish healthcare payer's perspective found that while calcipotriol/betamethasone dipropionate foam is more expensive than the ointment, it is more cost-effective due to its higher efficacy. This reduced the need for phototherapy, methotrexate, and consultation visits, offsetting the higher costs of the foam[5].

Market Projections

Given the positive clinical trial results and favorable cost-utility analyses, the market for betamethasone dipropionate and calcipotriene formulations is expected to grow. The convenience and efficacy of these products, especially those using innovative delivery systems like PAD Technology, are likely to increase their adoption among both patients and healthcare providers.

FDA and Regulatory Status

The FDA is currently reviewing the application for Wynzora cream, and similar submissions are planned for the European Union. This regulatory progress is crucial for the widespread availability of these treatments and will likely influence market dynamics once approvals are granted[1].

Patient Convenience and Quality of Life

The PAD Technology used in some formulations, such as Wynzora cream, enhances patient convenience by providing a non-greasy, easily absorbable cream. This innovation has been praised for improving the treatment experience in daily routines, as highlighted by Jesper Lange, CEO of MC2 Therapeutics:

"Wynzora Cream takes the treatment experience in daily routines to a new level. Our PAD Technology has enabled an aqueous cream formulation that is designed for high convenience in daily routines illustrated by the positive patient-reported treatment convenience and quality of life outcomes in our Phase 3 trials."[1]

Expert Recommendations

Experts in dermatology recommend the use of the fixed combination of calcipotriol and betamethasone dipropionate for the topical treatment of psoriasis due to its strong scientific rationale and complementary efficacy and safety profiles. This recommendation is supported by randomized Phase 3 trials that have demonstrated high efficacy, favorable safety, and convenience of these formulations[4].

Illustrative Statistics

• PGA Treatment Success: 52% for Wynzora cream at week 4[1].
• mPASI Reduction: 68% for Wynzora cream at week 4[1].
• Patient-Reported Convenience: Significant improvements in treatment convenience and quality of life at weeks 4 and 8[1].
• Cost-Effectiveness: Calcipotriol/betamethasone dipropionate foam was found to be more cost-effective than the ointment due to reduced need for other therapies[5].

Conclusion

The combination of betamethasone dipropionate and calcipotriene has emerged as a highly effective and convenient treatment option for psoriasis. With positive clinical trial results, favorable cost-utility analyses, and regulatory approvals on the horizon, this treatment is poised to dominate the market for topical psoriasis treatments.

Key Takeaways

• Clinical Efficacy: The combination cream has shown significant efficacy in Phase 3 trials, outperforming other formulations.
• Patient Convenience: The use of PAD Technology enhances patient convenience and quality of life.
• Cost-Effectiveness: The treatment is cost-effective, reducing the need for more expensive therapies.
• Regulatory Status: The FDA and EU are reviewing applications for these formulations.
• Expert Recommendations: Dermatology experts recommend this combination for its strong scientific rationale and complementary efficacy and safety profiles.

FAQs

What is the primary use of betamethasone dipropionate and calcipotriene combination?

The primary use is for the topical treatment of psoriasis, leveraging the anti-inflammatory properties of betamethasone and the vitamin D analog properties of calcipotriene.

What are the key findings from the Phase 3 trials of Wynzora cream?

The trials showed a PGA treatment success rate of 52% and a 68% reduction in mPASI at week 4, with significant improvements in patient-reported convenience and quality of life.

How does the PAD Technology enhance the treatment experience?

The PAD Technology allows for a non-greasy, easily absorbable cream formulation that is designed for high convenience in daily routines.

Is the calcipotriol/betamethasone dipropionate foam more cost-effective than the ointment?

Yes, despite being more expensive, the foam is more cost-effective due to its higher efficacy, which reduces the need for other costly therapies.

What is the current regulatory status of these formulations?

The FDA and EU are currently reviewing applications for these formulations, with approvals expected to influence market dynamics.

Sources

1. AJMC: Calcipotriene, Betamethasone Dipropionate Cream Meets Phase 3 Trial Endpoints.
2. PubMed: Budget impact model in moderate-to-severe psoriasis vulgaris.
3. FDA: N22-185S018 Calcipotriene and Betamethasone dipropionate Clinical PREA.
4. Wiley Online Library: Randomized Phase 3 trial demonstrating high efficacy, favourable safety and convenience of a novel calcipotriol and betamethasone dipropionate cream for the treatment of psoriasis.
5. PubMed: A Cost-utility Analysis of Calcipotriol/Betamethasone Dipropionate Foam.