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Last Updated: November 15, 2019

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CLINICAL TRIALS PROFILE FOR CALCIPOTRIENE

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505(b)(2) Clinical Trials for Calcipotriene

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 Phase 0 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 Phase 0 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 Calcipotriene

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00279162 Efficacy and Safety of Calcipotriene/Betamethasone Gel/Ointment in Psoriasis Completed LEO Pharma Phase 3 2005-12-01 Patients will receive either a gel containing both calcipotriene plus betamethasone or gel with no active ingredients as treatment for their scalp psoriasis for 8 weeks. After this time all patients will receive the gel containing both calcipotriene and betamethasone for 44 weeks. In addition, patients will receive an ointment containing both calcipotriene plus betamethasone as treatment for their psoriasis of the trunk and limbs for 52 weeks. The objective is to study the short-term efficacy of the gel, and the short and long-term safety of the gel and the ointment.
NCT00437255 Efficacy, Safety, Preference and Response Duration of Clobex® Spray and Taclonex® Ointment in Psoriasis Completed Galderma Laboratories, L.P. Phase 4 2006-08-01 Evaluate the efficacy of Clobex® Spray as compared to Taclonex® Ointment in terms of Overall Disease Severity and Investigator Global Assessment.
NCT00608777 Effect of Topical Calcipotriene/Betamethasone (Taclonex) in Managing Localized Breakthrough in Moderate to Severe Plaque Psoriasis in Patients Receiving Efalizumab (Raptiva) Terminated Genentech, Inc. Phase 4 2008-01-01 The purpose of this study is to determine if calcipotriene/bethamethasone can safely and effectively manage the occurence of LMB (mild localized breakthrough) in patients recieving efalizumab (Raptiva) for moderate to severe plaque psoriasis. It is hypothesized that calcipotriene/betamethasone (Taclonex) could be used to manage LMB and thus allow patients to continue efalizumab without interruption.
NCT00608777 Effect of Topical Calcipotriene/Betamethasone (Taclonex) in Managing Localized Breakthrough in Moderate to Severe Plaque Psoriasis in Patients Receiving Efalizumab (Raptiva) Terminated Derm Research, PLLC Phase 4 2008-01-01 The purpose of this study is to determine if calcipotriene/bethamethasone can safely and effectively manage the occurence of LMB (mild localized breakthrough) in patients recieving efalizumab (Raptiva) for moderate to severe plaque psoriasis. It is hypothesized that calcipotriene/betamethasone (Taclonex) could be used to manage LMB and thus allow patients to continue efalizumab without interruption.
NCT00817219 Safety and Efficacy of TACLONEX Ointment in Adolescent Patients (Aged 12 to 17 Years) With Psoriasis Vulgaris Completed LEO Pharma Phase 2 2009-07-01 The purpose of this study is to evaluate the safety and efficacy of 4 weeks of TACLONEX ointment in adolescent patients with psoriasis vulgaris.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Calcipotriene

Condition Name

Condition Name for Calcipotriene
Intervention Trials
Psoriasis 10
Plaque Psoriasis 5
Psoriasis Vulgaris 4
Scalp Psoriasis 2
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Condition MeSH

Condition MeSH for Calcipotriene
Intervention Trials
Psoriasis 22
Keratosis, Actinic 2
Keratosis 2
Breast Neoplasms 1
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Clinical Trial Locations for Calcipotriene

Trials by Country

Trials by Country for Calcipotriene
Location Trials
United States 122
Canada 3
Germany 1
Israel 1
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Trials by US State

Trials by US State for Calcipotriene
Location Trials
Texas 11
California 9
Florida 9
North Carolina 7
Kentucky 6
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Clinical Trial Progress for Calcipotriene

Clinical Trial Phase

Clinical Trial Phase for Calcipotriene
Clinical Trial Phase Trials
Phase 4 7
Phase 3 6
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Calcipotriene
Clinical Trial Phase Trials
Completed 12
Recruiting 8
Not yet recruiting 3
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Clinical Trial Sponsors for Calcipotriene

Sponsor Name

Sponsor Name for Calcipotriene
Sponsor Trials
LEO Pharma 5
Stiefel, a GSK Company 3
GlaxoSmithKline 3
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Sponsor Type

Sponsor Type for Calcipotriene
Sponsor Trials
Industry 26
Other 16
NIH 1
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