Evaluation of the Efficacy, Safety and Toleration of CT327 Ointment in Patients With Psoriasis Vulgaris

Creabilis

Status and phase: Completed; Phase 2

Conditions: Psoriasis Vulgaris

Treatments: Drug: Placebo; Drug: CT327 0.1%; Drug: CT327 0.5%; Drug: CT327 0.05%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01465282

CT327-2003

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness of 3 dose strengths of CT327 ointment (0.05%, 0.1% and 0.05% w/w) compared to a placebo, when applied twice daily for up to 8 weeks, to the psoriatic plaques of patients with psoriasis vulgaris.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female subjects aged at least 18 years.
• Stable psoriasis vulgaris

Exclusion criteria

• Subjects with guttate, erythrodermic, exfoliative or pustular psoriasis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

---

160 participants in 4 patient groups, including a placebo group

0.05% (w/w) CT327 ointment

Experimental group

Description:

0.05% (w/w) CT327 ointment applied BID for up to 8 weeks.

Treatment:

Drug: CT327 0.05%

0.1% (w/w) CT327 ointment

Experimental group

Description:

0.1% (w/w) CT327 ointment applied BID for up to 8 weeks.

Treatment:

Drug: CT327 0.1%

0.5% (w/w) CT327 ointment

Experimental group

Description:

0.5% (w/w) CT327 ointment applied BID for up to 8 weeks.

Treatment:

Drug: CT327 0.5%

Placebo ointment

Placebo Comparator group

Description:

Placebo ointment

Treatment:

Drug: Placebo