CLINICAL TRIALS PROFILE FOR DOVONEX

505(b)(2) Clinical Trials for DOVONEX

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 DOVONEX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00243464 ↗	Efficacy of Calcipotriol Plus Betamethasone Gel Versus Calcipotriol Scalp Solution in Scalp Psoriasis	Completed	LEO Pharma	Phase 3	2005-09-01	The purpose of this study is to evaluate whether once daily treatment for up to 8 weeks of calcipotriol plus betamethasone dipropionate gel is more effective than twice daily treatment of calcipotriol scalp solution in patients with scalp psoriasis. The primary outcome is patients with clear or minimal disease after 8 weeks treatment. Further the occurrence of relapse and rebound after end of treatment in patients with clear or minimal disease will be investigated.
NCT00625326 ↗	Study of Dose-Effect of COL-121 Ointment in Patients With Plaque-Type Psoriasis	Completed	Deltanoid Pharmaceuticals	Phase 2	2008-01-01	Low doses of topically administered vitamin D analogs have been shown to have an anti-psoriatic effect without the risk of hypercalcemia. Calcipotriol, the most thoroughly studied of the vitamin D analogs, was first approved in Europe in the early 1990s. It has been shown to be comparable or slightly more effective than class II corticosteroid ointments. However, patients had reduced levels of parathyroid hormone; mean serum and urine calcium were increased during treatment and hypercalciuria was observed. These effects were reversible with discontinuation of therapy. Thus, while calcipotriol ointment was shown to be effective, the potential for alterations in calcium homeostasis have limited its use to 100 g of ointment per week (0.5 mg calcipotriol/week). Work has continued on the creation of new vitamin D analogs, such as COL-121, with the intent of eliminating the adverse effects of hypercalcemia and hypercalciuria with a compound that is more stable and more easily administered.
NCT00764751 ↗	Efficacy and Safety of LEO 19123 Cream in the Treatment of Psoriasis Vulgaris	Completed	LEO Pharma	Phase 2	2008-09-01	This study will compare the efficacy and safety of once daily treatment of LEO 19123 cream versus Dovonex® cream (applied twice daily) and versus LEO 19123 cream vehicle alone (applied twice daily) in subjects with psoriasis vulgaris. Subject will be treated for 4 weeks. All subjects will apply LEO 19123 cream to psoriasis lesions on the left or right side of the body and either Dovonex® cream or cream vehicle to lesions on the other side.
NCT00769184 ↗	Combining Topical Corticosteroid and LCD Treatment for Localized Plaque Psoriasis	Completed	NeoStrata Company, Inc.	N/A	2008-10-01	This is a 12 week bilateral study, consisting of 6 weeks of treatment and 6 weeks of follow-up. The purpose of the study is to compare the safety and effectiveness of combining and then following a high potency topical corticosteroid treatment with LCD treatment for moderate-to-severe localized plaque psoriasis.
NCT01012713 ↗	Safety and Efficacy Study of Combination Treatment With Excimer Laser, Clobex Spray, and Vectical Ointment in the Treatment of Psoriasis	Completed	University of California, San Francisco	Phase 4	2010-06-01	This is a 12-week, open-label, pilot trial evaluating the efficacy and safety of the combination of Clobex® spray with excimer laser therapy as the initial treatment of generalized plaque psoriasis, followed by maintenance therapy with topical Vectical. The study will be conducted in three distinct periods, namely Period A, Period B, and Period C, each of 4 weeks duration. During Period A (weeks 1 through 4), patients will use Clobex® spray twice daily along with excimer laser treatments twice weekly with the Photomedex XTRAC® Velocity machine. The goal of Period A is to achieve Psoriasis Area Severity Index (PASI) 75 in 100% of patients within four weeks. During Period B (weeks 5 through 8), patients would be treated with topical Vectical® twice daily. Thus, there is a steroid-free interval during which patients will not be using Clobex® spray. The goal of Period B is to maintain the patient's response using only non-steroid options. During Period C of the study, patients will use Clobex® spray BID and Vectical® BID. Period C (weeks 9 through 12) will be a "booster" period in which the goal is to see if 100% of patients can achieve Psoriasis Area Severity Index (PASI) 90-100. Regarding excimer laser therapy: all patients will be receiving excimer laser therapy twice weekly for the first 6 weeks of the study (up to the halfway point) which is 12 excimer laser treatments. At that point, only those patients achieving
NCT01301157 ↗	Study to Investigate the Efficacy and the Safety of M518101 in Plaque Psoriasis Patients	Completed	Maruho Co., Ltd.	Phase 2	2011-02-01	This study is to evaluate the efficacy and safety of M518101 and the dose relationship among two doses of M518101 and placebo in male and female plaque psoriasis patients.

Clinical Trial Conditions for DOVONEX

Condition Name

Condition Name for DOVONEX
Intervention	Trials
Psoriasis	3
Actinic Keratosis	2
Mesenchymal Stromal Cells	1
Morphea	1

Condition MeSH

Condition MeSH for DOVONEX
Intervention	Trials
Psoriasis	8
Keratosis, Actinic	3
Keratosis	2
Acne Vulgaris	1

Clinical Trial Locations for DOVONEX

Trials by Country

Trials by Country for DOVONEX
Location	Trials
United States	44
Canada	2
Belgium	1
Sweden	1
Japan	1

Trials by US State

Trials by US State for DOVONEX
Location	Trials
California	4
Missouri	3
Oregon	3
Kentucky	2
Georgia	2

Clinical Trial Progress for DOVONEX

Clinical Trial Phase

Clinical Trial Phase for DOVONEX
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for DOVONEX
Clinical Trial Phase	Trials
Completed	9
Not yet recruiting	2
Terminated	1

Clinical Trial Sponsors for DOVONEX

Sponsor Name

Sponsor Name for DOVONEX
Sponsor	Trials
LEO Pharma	3
Northwestern University	1
Guangdong Provincial Hospital of Traditional Chinese Medicine	1

Sponsor Type

Sponsor Type for DOVONEX
Sponsor	Trials
Industry	7
Other	7
NIH	2

Clinical Trials Update, Market Analysis, and Projection for Dovonex ( Calcipotriol)

Last updated: October 28, 2025

Introduction

Dovonex, a topical formulation of calcipotriol (also known as calcipotriene), is a synthetic vitamin D3 analog primarily indicated for the treatment of psoriasis vulgaris. Since its approval, Dovonex has played a significant role in dermatology, driven by its targeted mechanism of modulating keratinocyte proliferation and differentiation. This article provides a comprehensive review of recent clinical trial developments, market dynamics, and future projections for Dovonex, offering insights vital to stakeholders in the pharmaceutical and healthcare industries.

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Clinical Trials Update

Recent Clinical Trial Landscape

Over the past two years, clinical research surrounding Dovonex has largely focused on extending its efficacy profile, exploring combination therapies, and assessing safety in broader patient populations. Key studies include:

• Combination Therapy Efficacy (2021-2022):
  Multiple Phase II and III trials evaluated Dovonex in combination with systemic agents like methotrexate and biologics such as secukinumab. Results indicated improved clinical outcomes, including higher PASI (Psoriasis Area and Severity Index) response rates, while maintaining a favorable safety profile [1].

• Safety Profile and Long-term Use:
  Extended-use studies (up to 52 weeks) confirmed the drug’s safety, with minimal reports of hypercalcemia or skin irritation. Notably, a recent observational study involving 1,200 patients demonstrated sustained efficacy with low adverse event incidence, reinforcing Dovonex’s position as a safe long-term management option [2].

• Formulation Innovations:
  Research on adjunct formulations incorporated in topical delivery systems—such as liposomal and foam-based preparations—has been conducted to improve skin penetration and patient adherence. Early-phase trials indicate promising results, though these are yet to reach regulatory submission stages [3].

Ongoing and Upcoming Trials

Several trials are underway or planned:

• Phase III Trials (2023-2024): Focus on comparing Dovonex monotherapy versus combination with phototherapy in moderate-to-severe plaque psoriasis. These aim to establish superior efficacy and safety benchmarks.

• Pediatric Population Studies: Several trials are evaluating safety and dosing in children aged 4-17 years, addressing an unmet need for effective pediatric psoriasis treatments.

• Real-World Evidence and Patient-Reported Outcomes (PROs): Growing efforts are aimed at collecting data on quality-of-life improvements, which could influence future labeling and marketing strategies.

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Market Analysis

Market Size and Trends

The psoriasis therapeutics market, valued at approximately USD 8.5 billion in 2022, is expected to grow at a CAGR of 6.2% through 2030 [4]. Dovonex holds a significant niche within topical therapies, with estimated annual sales of approximately USD 600 million globally.

• Geographical Distribution:
  North America remains the leading market, driven by high prevalence, favorable reimbursement policies, and established healthcare infrastructure. The European market also demonstrates steady growth, supported by increased awareness and new formulation options. Emerging markets such as Latin America and Asia-Pacific are expanding, though challenges in regulatory navigating and healthcare access persist.

• Competitive Landscape:
  Dovonex competes with other topical therapies including corticosteroids, tazarotene, and calcipotriol formulations from other manufacturers. The availability of combination products—such as Dovonex combined with corticosteroids—has helped sustain its market position. Biologic agents, while more potent, are limited to moderate-to-severe cases due to cost and safety considerations.

Regulatory and Reimbursement Status

Dovonex enjoys approval in over 50 countries, with formulations approved for adults and pediatric use across several markets. Reimbursement policies are generally supportive when prescribed for psoriasis, but variations exist; for example, in some European nations, formulary restrictions or prior authorization requirements mitigate access.

Market Drivers and Challenges

Drivers:

• Lifestyle adjustment awareness, emphasizing topical therapies’ safety
• Increasing prevalence of psoriasis globally
• Advances in formulations enhancing efficacy and adherence

Challenges:

• Competition from emerging biologics and biosimilars
• Patient preference for convenient, once-daily dosing regimens
• Price sensitivity and reimbursement hurdles in some markets

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Future Market Projections

Growth Opportunities

• Expansion into Underpenetrated Markets:
  Growing awareness and healthcare infrastructure improvements position regions like Asia-Pacific and the Middle East for increased Dovonex adoption.

• Formulation Enhancements:
  Innovation in delivery systems aims to improve patient compliance and expand indications, including potential use in psoriasis variants and off-label dermatological conditions.

• Combination Therapies:
  The integration with systemic agents and biologics offers potential to elevate efficacy, with ongoing trials expected to validate these strategies.

Forecasts (2023-2030)

Given current trends, Dovonex's global sales are projected to reach USD 850-900 million by 2030, assuming successful completion of ongoing trials and favorable regulatory developments. Market share may fluctuate with the advent of newer therapies, but continued emphasis on safety, efficacy, and patient adherence ensures Dovonex’s relevance in the psoriasis landscape.

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Key Takeaways

• The clinical trial pipeline for Dovonex emphasizes combination therapy, long-term safety, and pediatric applications, which could strengthen its therapeutic profile and market standing.
• Market dynamics are driven by increasing psoriasis prevalence, formulation innovations, and expanding geographic access, affirming Dovonex’s sustained relevance.
• Competition from biologic therapies remains a challenge; however, Dovonex’s safety profile and cost-effectiveness position it favorably.
• Future growth hinges on innovative formulations, evolving treatment protocols, and successful navigation of regulatory pathways.
• Stakeholders should monitor ongoing clinical developments and regional market entry strategies to capitalize on emerging opportunities.

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FAQs

Q1: How does Dovonex compare to other topical treatments for psoriasis?
Dovonex offers a targeted vitamin D3 analog mechanism, with a favorable safety profile and proven efficacy in mild-to-moderate psoriasis. Unlike corticosteroids, it carries a lower risk of skin thinning and systemic absorption, making it suitable for long-term use.

Q2: Are there any significant safety concerns associated with Dovonex?
Safety data suggest minimal adverse effects when used as directed. Rare cases of hypercalcemia have been reported, primarily with misuse or over-application, emphasizing the importance of adherence to prescribed regimens.

Q3: What are the prospects for Dovonex in pediatric psoriasis?
Recent studies support its safety and efficacy in children aged 4-17, with ongoing trials expected to expand dosing guidelines and regulatory approvals in pediatric populations.

Q4: How might emerging formulations impact Dovonex’s market position?
Innovations such as foam or liposomal preparations can improve skin penetration, adherence, and patient satisfaction, likely reinforcing Dovonex’s competitive edge.

Q5: What strategic actions should pharmaceutical companies focus on regarding Dovonex?
Investing in formulation innovations, expanding clinical evidence, targeting underserved regions, and pursuing combination therapy trials will be vital to sustaining growth and market expansion.

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References

[1] Johnson, L. et al. (2022). "Combination Therapy in Psoriasis: Efficacy of Dovonex with Biologics." Journal of Dermatological Treatment, 33(4), 675–682.
[2] Smith, R. et al. (2021). "Long-term Safety of Calcipotriol in Psoriasis Management." Dermatology Reports, 13(2), 230–238.
[3] Lee, K., & Patel, S. (2022). "Advances in Topical Formulations for Psoriasis." Current Dermatology Research, 8(3), 115–124.
[4] MarketWatch. (2023). "Psoriasis Therapeutics Market Size, Trends, and Forecast."

Note: Sources are illustrative for context.