CLINICAL TRIALS PROFILE FOR DOVONEX
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505(b)(2) Clinical Trials for DOVONEX
| 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 | >Sponsor | >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
|
| 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. |
| NCT01422434 ↗ | LEO 90105 Ointment in Japanese Subjects With Psoriasis | Completed | Quintiles, Inc. | Phase 3 | 2011-07-01 | The purpose of this study is to compare the efficacy of LEO 90105 ointment applied once daily with Dovonex® ointment applied twice daily and with Rinderon®-DP ointment applied once daily in Japanese subjects with psoriasis vulgaris. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for DOVONEX
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