Study to Compare U0267 Against Vehicle in Subjects With Plaque-type Psoriasis Two of Two Phase 3 Studies

Stiefel

Status and phase: Completed; Phase 3

Conditions: Psoriasis

Treatments: Drug: Vehicle foam; Drug: U0267 Foam

Study type: Interventional

Funder types: Industry

Identifiers

NCT00689481

U0267-302 (Other Identifier)

114742

Details and patient eligibility

About

The purpose of the study is to demonstrate the safety and efficacy of U0267 in subjects with plaque-type psoriasis.

Enrollment: 323 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female subjects at least 12 years old and in good general health.
• Mild to moderate plaque-type psoriasis

Exclusion criteria

• Known allergy or other adverse reaction to calcipotriene or other vitamin D analogs; or to any component of the investigational formulations
• History of hypercalcemia or of vitamin D toxicity.
• Diagnosis of generalized pustular or erythrodermic exfoliative psoriasis.
• Other serious skin disorder or any chronic medical condition that is not well controlled.
• Use of non-biologic systemic anti-psoriatic therapy or biologic therapy within four weeks of enrollment.
• Use of topical therapies that have a known beneficial effect on psoriasis, within 2 weeks of enrollment.
• Systemic medications for other medical conditions that are known to affect psoriasis within the past four weeks of enrollment.
• Use of any investigational therapy within 4 weeks of enrollment.
• Pregnant women, women who are breast feeding, or sexually active women of child bearing potential who are not practicing an acceptable method of birth control.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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323 participants in 2 patient groups, including a placebo group

U0267 foam

Experimental group

Description:

U0267 is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.

Treatment:

Drug: U0267 Foam

Vehicle foam

Placebo Comparator group

Description:

Vehicle foam is the same as the U0267 foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.

Treatment:

Drug: Vehicle foam