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Last Updated: March 28, 2024

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.
>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
Plaque Psoriasis 1
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Condition MeSH

Condition MeSH for DOVONEX
Intervention Trials
Psoriasis 8
Keratosis, Actinic 2
Keratosis 2
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Clinical Trial Locations for DOVONEX

Trials by Country

Trials by Country for DOVONEX
Location Trials
United States 44
Canada 2
Denmark 1
China 1
Belgium 1
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Trials by US State

Trials by US State for DOVONEX
Location Trials
California 4
Missouri 3
Oregon 3
Georgia 2
Illinois 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
Enrolling by invitation 1
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Clinical Trial Sponsors for DOVONEX

Sponsor Name

Sponsor Name for DOVONEX
Sponsor Trials
LEO Pharma 3
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) 1
University of California, Los Angeles 1
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Sponsor Type

Sponsor Type for DOVONEX
Sponsor Trials
Industry 7
Other 6
NIH 2
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