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Last Updated: February 11, 2025

CLINICAL TRIALS PROFILE FOR DOVONEX


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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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Dovonex

Condition Name

Condition Name for Dovonex
Intervention Trials
Psoriasis 3
Actinic Keratosis 2
Drug Toxicity 1
Localized Scleroderma 1
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Condition MeSH

Condition MeSH for Dovonex
Intervention Trials
Psoriasis 8
Keratosis, Actinic 2
Keratosis 2
Acne Vulgaris 1
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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
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Trials by US State

Trials by US State for Dovonex
Location Trials
California 4
Missouri 3
Oregon 3
Kentucky 2
Georgia 2
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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
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Clinical Trial Status

Clinical Trial Status for Dovonex
Clinical Trial Phase Trials
Completed 9
Not yet recruiting 2
Terminated 1
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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
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Sponsor Type

Sponsor Type for Dovonex
Sponsor Trials
Industry 7
Other 6
NIH 2
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Dovonex (Calcipotriene): Clinical Trials, Market Analysis, and Projections

Introduction

Dovonex, a topical cream containing calcipotriene, is a widely used treatment for plaque psoriasis. This article delves into the clinical trials, market analysis, and future projections for this medication.

Clinical Trials Overview

Efficacy and Safety

Clinical trials have consistently shown that Dovonex is effective in treating plaque psoriasis. In controlled clinical trials, improvement in patients typically begins after 2 weeks of therapy. After 8 weeks, approximately 50% of patients show at least marked improvement, with around 4% achieving complete clearing[1][4].

A significant study involved transferring patients from a calcipotriene/betamethasone dipropionate two-compound product to maintenance treatment with calcipotriene cream. This study demonstrated that maintenance treatment with calcipotriene cream was both effective and safe, with a mean percentage change in the Psoriasis Area and Severity Index (PASI) of -44.5% compared to -33.1% in the vehicle group[3].

Adverse Reactions

The most common adverse reactions reported in clinical trials include skin irritation, burning, itching, erythema, dry skin, peeling, rash, and dermatitis. These reactions occur in approximately 10-15% of patients. More severe reactions such as skin atrophy, hyperpigmentation, and hypercalcemia are less common, occurring in less than 1% of patients[1][4].

Special Considerations

Patients using Dovonex should avoid excessive exposure to natural or artificial sunlight due to the potential for calcipotriene to enhance the effect of ultraviolet radiation (UVR) in inducing skin tumors. This caution is particularly relevant for males, as studies in albino hairless mice showed a statistically significant reduction in the time required for UVR to induce skin tumors[1][4].

Market Analysis

Market Presence

Dovonex, originally developed by LEO Pharma, has been a significant player in the psoriasis treatment market. In 2012, Sandoz launched the first generic version of calcipotriene cream, marking a significant shift in the market landscape. The generic version is marketed at the same 0.005% strength as the branded Dovonex cream[2].

Sales and Revenue

As of 2012, the U.S. sales for the branded version of calcipotriene cream were approximately $118.8 million for the 12 months ending in May. The introduction of generic versions has likely impacted the revenue of the branded product, increasing competition and potentially reducing prices[2].

Market Projections

Competitive Landscape

The psoriasis treatment market is increasingly competitive, with various topical and systemic treatments available. The introduction of generic calcipotriene creams has expanded patient access and reduced costs, but it also means that Dovonex and its generics must compete with other treatments such as biologics and newer topical agents.

Future Trends

The trend towards generic and biosimilar medications is expected to continue, which may further erode the market share of branded psoriasis treatments. However, the efficacy and safety profile of calcipotriene, combined with its long-standing presence in the market, suggest that it will remain a viable treatment option for plaque psoriasis.

Patient Access and Affordability

The availability of generic versions of calcipotriene cream is likely to improve patient access and affordability. This is particularly important for chronic conditions like psoriasis, where long-term treatment is often necessary.

Key Takeaways

  • Efficacy: Dovonex has been shown to be effective in treating plaque psoriasis, with improvements typically beginning after 2 weeks of therapy.
  • Safety: Common adverse reactions include skin irritation and other dermatological issues, with a caution against excessive sunlight exposure.
  • Market Presence: The introduction of generic versions has increased competition and potentially reduced prices.
  • Future Trends: The market is expected to remain competitive, with generics and biosimilars playing a significant role.

FAQs

What is Dovonex used for?

Dovonex (calcipotriene) is used for the treatment of plaque psoriasis.

How effective is Dovonex in treating psoriasis?

Clinical trials have shown that approximately 50% of patients using Dovonex show at least marked improvement in the signs and symptoms of psoriasis after 8 weeks of therapy.

What are the common adverse reactions associated with Dovonex?

Common adverse reactions include skin irritation, burning, itching, erythema, dry skin, peeling, rash, and dermatitis.

Should patients using Dovonex avoid sunlight?

Yes, patients using Dovonex should avoid excessive exposure to natural or artificial sunlight due to the potential for calcipotriene to enhance the effect of UVR in inducing skin tumors.

Is Dovonex available in generic form?

Yes, generic versions of calcipotriene cream are available, which was first introduced by Sandoz in 2012.

How does the generic version of Dovonex impact the market?

The generic version increases competition, potentially reducing prices and improving patient access and affordability.

Sources

  1. Access Data FDA: Dovonex® (calcipotriene) Cream, 0.005% Rx only[1].
  2. Dermatology Times: Sandoz launches first-to-file calcipotriene cream, the first generic version of LEO Pharma’s Dovonex 0.005 percent[2].
  3. PubMed: Use of calcipotriene cream (Dovonex cream) following treatment with a calcipotriene/betamethasone dipropionate two-compound product[3].
  4. Access Data FDA: Dovonex - accessdata.fda.gov[4].

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