CLINICAL TRIALS PROFILE FOR CALCIPOTRIENE

505(b)(2) Clinical Trials for Calcipotriene

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT02019355 ↗	Actinic Keratosis Study	Completed	Washington University School of Medicine	Early Phase 1	2013-10-01	The main purpose of this study is to determine the effectiveness of a new combination therapy for actinic keratosis. This study investigates a new indication for an FDA-approved topical medication, calcipotriol, for treatment of actinic keratosis, including how well it works and how safe it is when used in combination with the standard of care medication (5-fluorouracil) for the skin condition.
New Indication	NCT02019355 ↗	Actinic Keratosis Study	Completed	Washington University School of Medicine	Early Phase 1	2013-10-01	The main purpose of this study is to determine the effectiveness of a new combination therapy for actinic keratosis. This study investigates a new indication for an FDA-approved topical medication, calcipotriol, for treatment of actinic keratosis, including how well it works and how safe it is when used in combination with the standard of care medication (5-fluorouracil) for the skin condition.

All Clinical Trials for 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.
NCT00608777 ↗	Effect of Topical Calcipotriene/Betamethasone (Taclonex) in Managing Localized Breakthrough in Moderate to Severe Plaque Psoriasis in Patients Receiving Efalizumab (Raptiva)	Terminated	Genentech, Inc.	Phase 4	2008-01-01	The purpose of this study is to determine if calcipotriene/bethamethasone can safely and effectively manage the occurence of LMB (mild localized breakthrough) in patients recieving efalizumab (Raptiva) for moderate to severe plaque psoriasis. It is hypothesized that calcipotriene/betamethasone (Taclonex) could be used to manage LMB and thus allow patients to continue efalizumab without interruption.
NCT00608777 ↗	Effect of Topical Calcipotriene/Betamethasone (Taclonex) in Managing Localized Breakthrough in Moderate to Severe Plaque Psoriasis in Patients Receiving Efalizumab (Raptiva)	Terminated	Derm Research, PLLC	Phase 4	2008-01-01	The purpose of this study is to determine if calcipotriene/bethamethasone can safely and effectively manage the occurence of LMB (mild localized breakthrough) in patients recieving efalizumab (Raptiva) for moderate to severe plaque psoriasis. It is hypothesized that calcipotriene/betamethasone (Taclonex) could be used to manage LMB and thus allow patients to continue efalizumab without interruption.
NCT00656019 ↗	Development of Vitamin D as a Therapy for Breast Cancer - Phase 2	Completed	United States Department of Defense	Phase 2	2008-04-01	This study will assess whether levels of vitamin D impact the characteristics of a woman's breast cancer at diagnosis, and whether a short course of vitamin D in women with low levels of vitamin D changes the gene expression of their breast cancers.
NCT00656019 ↗	Development of Vitamin D as a Therapy for Breast Cancer - Phase 2	Completed	Stanford University	Phase 2	2008-04-01	This study will assess whether levels of vitamin D impact the characteristics of a woman's breast cancer at diagnosis, and whether a short course of vitamin D in women with low levels of vitamin D changes the gene expression of their breast cancers.

Clinical Trial Conditions for Calcipotriene

Condition Name

Condition Name for Calcipotriene
Intervention	Trials
Psoriasis	12
Plaque Psoriasis	6
Psoriasis Vulgaris	5
Nail Psoriasis	3

Condition MeSH

Condition MeSH for Calcipotriene
Intervention	Trials
Psoriasis	28
Keratosis, Actinic	3
Keratosis	3
Carcinoma, Squamous Cell	2

Clinical Trial Locations for Calcipotriene

Trials by Country

Trials by Country for Calcipotriene
Location	Trials
United States	224
Canada	3
Israel	1
Germany	1

Trials by US State

Trials by US State for Calcipotriene
Location	Trials
Texas	14
California	13
Florida	12
Kentucky	10
North Carolina	10

Clinical Trial Progress for Calcipotriene

Clinical Trial Phase

Clinical Trial Phase for Calcipotriene
Clinical Trial Phase	Trials
Phase 4	12
Phase 3	7
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Calcipotriene
Clinical Trial Phase	Trials
Completed	23
Not yet recruiting	4
Withdrawn	3

Clinical Trial Sponsors for Calcipotriene

Sponsor Name

Sponsor Name for Calcipotriene
Sponsor	Trials
LEO Pharma	7
GlaxoSmithKline	4
Psoriasis Treatment Center of Central New Jersey	4

Sponsor Type

Sponsor Type for Calcipotriene
Sponsor	Trials
Industry	37
Other	23
NIH	2

Calcipotriene: Clinical Trials, Market Analysis, and Projections

Introduction to Calcipotriene

Calcipotriene, also known as calcipotriol, is a synthetic derivative of calcitriol, a form of vitamin D. It is widely used in dermatology for the treatment of various skin conditions, including psoriasis and certain types of skin cancer.

Clinical Trials and Research

Combination Therapy for Skin Cancer

A notable clinical trial involves the use of calcipotriene in combination with 5-fluorouracil (5-FU) for the treatment of basal cell carcinoma (BCC). This trial, conducted by Boston University, compares the efficacy of a standard 5-FU cream against a combination cream of 5-FU and calcipotriene. The goal is to determine if the combination cream can clear cancer in a shorter time frame (7-14 days) compared to the standard 28-day treatment with 5-FU alone. Participants are monitored over three years to assess the long-term success of the treatment[1].

Mechanism of Action

Calcipotriene works by modulating cell differentiation and proliferation, which helps in normalizing skin cell growth. When combined with 5-FU, it enhances the effectiveness of the treatment by targeting cancerous cells specifically while minimizing damage to healthy tissue. This synergistic effect is crucial for treating BCC patients[1].

Market Analysis

Global Market Size and Forecast

The global calcipotriene ointment market was valued at USD 1101 million in 2023 and is projected to grow to USD 1755.3 million by 2030, with a Compound Annual Growth Rate (CAGR) of 6.9% during the forecast period. This growth is driven by increasing consumer awareness, government initiatives, and robust domestic demand, particularly in the Asia-Pacific region[5].

Regional Analysis

North America and Europe are experiencing steady growth in the calcipotriene market, driven by advanced healthcare systems and higher consumer awareness. However, the Asia-Pacific region, particularly China, leads the global market due to supportive policies and a strong manufacturing base[5].

Market Dynamics and Trends

The market is influenced by several factors, including the increasing prevalence of skin conditions such as psoriasis and basal cell carcinoma. The development of new formulations and technologies, like the PAD Technology used in Wynzora Cream, also contributes to market growth. This technology allows for better solubility, stability, and penetration of active ingredients, making treatments more effective and user-friendly[4].

Market Projections

Segment Analysis

The calcipotriene market is segmented by type (e.g., 30G/Stick, 15G/Stick) and application. The report provides detailed insights into market sizing, segmentation, and the sales quantity and revenue generated by different types and applications. For instance, the North America calcipotriene ointment sales quantity is analyzed by type and application for both historical and forecasted periods[5].

Competitive Analysis

The market is competitive, with several key players involved in the development and commercialization of calcipotriene products. Companies like MC2 Therapeutics, with their FDA-approved Wynzora Cream, are significant players. Wynzora Cream combines calcipotriene with betamethasone dipropionate and uses PAD Technology for enhanced efficacy and patient convenience[4].

FDA Approvals and Regulatory Landscape

Wynzora Cream Approval

Wynzora Cream, a topical treatment containing calcipotriene 0.005% and betamethasone dipropionate 0.064%, was approved by the FDA in 2020 for the treatment of plaque psoriasis in adults. This approval was based on positive phase 3 results that demonstrated the efficacy and safety of Wynzora Cream compared to a placebo and an active comparator[4].

Future Outlook

Emerging Therapies

The future of calcipotriene and related therapies looks promising with ongoing research and development. For example, the combination of calcipotriene with other agents, like 5-FU, is being explored for its potential in treating skin cancers. Additionally, advancements in delivery technologies, such as PAD Technology, are expected to enhance patient compliance and treatment outcomes[1][4].

Market Opportunities and Challenges

The market faces opportunities such as increasing demand for effective topical treatments and advancements in technology. However, challenges include competition from other therapeutic options and the need for continuous innovation to stay ahead in the market. The COVID-19 pandemic has also had an impact on the market, but the sector is expected to recover and grow as healthcare systems normalize[2][5].

Key Takeaways

• Clinical Trials: Ongoing trials are exploring the efficacy of calcipotriene in combination with other agents for treating skin cancers and psoriasis.
• Market Growth: The global calcipotriene ointment market is projected to grow significantly, driven by increasing consumer awareness and technological advancements.
• Regional Analysis: Asia-Pacific, particularly China, is a key region driving market growth due to robust domestic demand and supportive policies.
• FDA Approvals: Wynzora Cream, combining calcipotriene and betamethasone dipropionate, has been approved by the FDA for plaque psoriasis treatment.
• Future Outlook: Emerging therapies and advancements in delivery technologies are expected to enhance treatment outcomes and patient compliance.

FAQs

What is calcipotriene used for?

Calcipotriene is used for the treatment of various skin conditions, including plaque psoriasis and basal cell carcinoma.

What is the mechanism of action of calcipotriene?

Calcipotriene modulates cell differentiation and proliferation, helping to normalize skin cell growth. It is often combined with other agents to enhance its effectiveness.

What is the current market size of the global calcipotriene ointment market?

The global calcipotriene ointment market was valued at USD 1101 million in 2023.

What is the projected growth rate of the global calcipotriene ointment market?

The market is projected to grow at a CAGR of 6.9% from 2023 to 2030.

Which regions are driving the growth of the calcipotriene market?

North America, Europe, and particularly the Asia-Pacific region, are driving the growth of the calcipotriene market.

References

1. Withpower.com: "5-Fluorouracil + Calcipotriene Cream for Skin Cancer - Clinical Trials"
2. Cognitivemarketresearch.com: "Calcipotriene Market Report 2024 (Global Edition)"
3. Delveinsight.com: "Revolutionizing Psoriasis Treatment: Advancements in the US Market"
4. Dermatologytimes.com: "FDA approves plaque psoriasis topical - Dermatology Times"
5. Globalinforesearch.com: "Global Calcipotriol(Calcipotriene) Ointment Market 2024 by Manufacturers, Regions, Type and Application, Forecast to 2030"