Safety & Effectiveness of Clobex Spray, Followed by Calcitriol Ointment in Management of Plaque Psoriasis

Galderma

Status and phase: Completed; Phase 3

Conditions: Psoriasis

Treatments: Drug: clobetasol propionate spray 0.05%; Drug: calcitriol ointment

Study type: Interventional

Funder types: Industry

Identifiers

NCT00658788

US10085

Details and patient eligibility

About

The primary objectives of this study are to evaluate the safety & efficacy of consecutive treatments of Clobex® Spray and Silkis® Ointment in the management of plaque psoriasis.

Full description

Same as above.

Enrollment: 305 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of moderate to severe plaque psoriasis, defined as 3% - 20% treatable body surface area
• Overall Disease Severity of at least 3 (moderate)

Exclusion criteria

• Surface area involvement too large (>20% BSA)
• Psoriasis involving only the scalp, groin, axillae, and/or other intertriginous areas

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

305 participants in 1 patient group

Study Treatment

Active Comparator group

Description:

clobetasol propionate spray 0.05% Other Names: Clobex® Spray 0.05% clobetasol propionate spray, 0.05%, applied topically twice daily calcitriol ointment Other Names: Calcitriol Ointment calcitriol ointment, 3 µg/g, applied topically, not to exceed 30 g daily

Treatment:

Drug: clobetasol propionate spray 0.05%

Drug: calcitriol ointment