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Generated: December 12, 2018

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CLINICAL TRIALS PROFILE FOR CALCIPOTRIENE

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Clinical Trials for Calcipotriene

Trial ID Title Status Sponsor Phase Summary
NCT00279162 Efficacy and Safety of Calcipotriene/Betamethasone Gel/Ointment in Psoriasis Completed LEO Pharma Phase 3 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 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 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 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 The purpose of this study is to evaluate the safety and efficacy of 4 weeks of TACLONEX ointment in adolescent patients with psoriasis vulgaris.
NCT01000714 Determination of the Efficacy and Safety of Psirelax in the Relief of the Disease in Psoriasis Completed Etwal Ltd. Phase 2 Psoriasis is a chronic disorder characterized by erythematous scaly patches which affect the scalp, trunk, extensor surfaces of the limbs and the genital area. The common form of psoriasis is referred to as psoriasis vulgaris. There are several variants of psoriasis such as guttate psoriasis, inverse psoriasis, pustular psoriasis and erythrodermic psoriasis. Psoriasis is highly prevalent in the general population, mainly as a result of its chronicity and the absence of a cure. The estimates of psoriasis prevalence are within the range of 0.5% to 4%. The diagnosis of psoriasis is made on a clinical base, usually by physical examination, performed by a dermatologist. Although skin biopsy may be useful in some cases, there is no laboratory test which may serve as a reference standard to the clinical diagnosis of psoriasis. Psoriasis in its mild cases per se is not associated with excess mortality, however, the disease may affect quality of life of affected patients to a substantial degree. Psoriasis may be readily apparent to others because of scales and redness of the skin. The skin may itch and scales may shed from the patients to the environment or directly on other people. Feelings of stigmatization and major changes in life-style caused by psoriasis have been documented in numerous studies. The burden of the disease may be exaggerated due to expensive therapy and complicated therapeutic regimes Patients with mild to moderate psoriasis are usually treated with topical treatments. Photo-therapy or systemic treatments are reserved to patients with moderate to severe disease. Topical corticosteroids may lead to rapid improvement in psoriasis, however rapid relapse following discontinuation is the common practice leading to chronic use. Calcipotriene ointment may also be used and requires 8 to 12 weeks of use for maximal effect and often causes local irritation, particularly when used on the face. The use is limited to 100 gr/week due to hypercalcemia that might follow systemic absorption. Vitamin A derivative tazarotene may be also be used for plaque psoriasis. Although it can produce longer remissions than topical steroids, local irritation, cost, and teratogenicity limit its use. Coal tar products may be used as steroid-sparing agents, especially useful for enhancing the efficacy of natural sunlight and phototherapy. Application can be cumbersome because of irritation, unpleasant smell, brown color that can stain clothing, and propensity to cause folliculitis. All of the above treatments are particularly problematic for the face and genital psoriasis due to the potential side effects and mainly possible severe irritation reducing patients compliance. Psirelax is a novel topical medication directed for the treatment of patients with psoriasis. The formulation of Psirelax includes the following substances: 5%-15% quince seeds jelly, 10%-40% natural base cream (e.g. Ferntree Cottage Pure Base Cream), 55%-75% mixture of natural anti-oxidants (e.g. Vitamin E, wheat germ oil, Safflower oil), natural skin softening agents (e.g. sweet almond oil, sesame oil), natural absorption aids (e.g. jojoba oil, vegetable squalene), natural tissue regenerating and protecting agents (e.g. grape seed oil, sunflower oil), natural preservatives (e.g. paraben, tea trea essential oil, thyme essential oil, grapefruit seed extract, Vitamin E) and natural thickening agents (e.g. bee wax, aloevera, medicinal Vaseline, coconut oil, guar gum, palm oil, borax) In a preliminary observation, a patient with severe psoriasis applied Psirelax three times each day during four days. The patient reported complete disappearance of the psoriatic plaques and pruritus was reduced by 70%. It was suggested to conduct an open study to assess the effect of Psirelax in patients with psoriasis vulgaris. The aim of this study is to examine the safety and efficacy of Psirelax in the treatment of psoriasis.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Calcipotriene

Condition Name

Condition Name for Calcipotriene
Intervention Trials
Psoriasis 9
Plaque Psoriasis 4
Psoriasis Vulgaris 3
Scalp Psoriasis 2
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Condition MeSH

Condition MeSH for Calcipotriene
Intervention Trials
Psoriasis 19
Acne Vulgaris 1
Breast Neoplasms 1
Pruritus 1
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Clinical Trial Locations for Calcipotriene

Trials by Country

Trials by Country for Calcipotriene
Location Trials
United States 105
Canada 3
Germany 1
Israel 1
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Trials by US State

Trials by US State for Calcipotriene
Location Trials
Texas 9
California 8
Florida 8
North Carolina 6
Virginia 5
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Clinical Trial Progress for Calcipotriene

Clinical Trial Phase

Clinical Trial Phase for Calcipotriene
Clinical Trial Phase Trials
Phase 4 6
Phase 3 5
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Calcipotriene
Clinical Trial Phase Trials
Completed 11
Recruiting 6
Not yet recruiting 2
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Clinical Trial Sponsors for Calcipotriene

Sponsor Name

Sponsor Name for Calcipotriene
Sponsor Trials
LEO Pharma 4
Stiefel, a GSK Company 3
GlaxoSmithKline 3
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Sponsor Type

Sponsor Type for Calcipotriene
Sponsor Trials
Industry 20
Other 14
NIH 1
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Serving hundreds of leading biopharmaceutical companies globally:

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