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Generated: December 15, 2018

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CLINICAL TRIALS PROFILE FOR DOVONEX

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Clinical Trials for Dovonex

Trial ID Title Status Sponsor Phase Summary
NCT00243464 Efficacy of Calcipotriol Plus Betamethasone Gel Versus Calcipotriol Scalp Solution in Scalp Psoriasis Completed LEO Pharma Phase 3 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 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 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 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 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 Sponsor Phase Summary

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Clinical Trial Conditions for Dovonex

Condition Name

Condition Name for Dovonex
Intervention Trials
Psoriasis 2
Actinic Keratosis 1
Psoriasis of Scalp 1
Acne Vulgaris 1
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Condition MeSH

Condition MeSH for Dovonex
Intervention Trials
Psoriasis 6
Scleroderma, Localized 1
Keratosis, Actinic 1
Keratosis 1
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Clinical Trial Locations for Dovonex

Trials by Country

Trials by Country for Dovonex
Location Trials
United States 19
Canada 2
Japan 1
France 1
Denmark 1
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Trials by US State

Trials by US State for Dovonex
Location Trials
California 3
Oregon 1
Connecticut 1
Florida 1
Georgia 1
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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 7
Terminated 1
Unknown status 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
Quintiles, Inc. 1
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Sponsor Type

Sponsor Type for Dovonex
Sponsor Trials
Industry 6
Other 4
NIH 1
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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Citi
UBS
Mallinckrodt
Dow
Merck
Queensland Health
Chinese Patent Office
US Army

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