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

Phase 2

Completed

• Conditions: Psoriasis Vulgaris
• Interventions: Drug: CT327 0.05%; Drug: CT327 0.1%; Drug: CT327 0.5%; Drug: Placebo

• Registration Number: NCT01465282
• Lead Sponsor: Creabilis SA

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-01
• Study First Submitted QC: 2011-11-02
• Study First Posted: 2011-11-04
• Study Start: 2011-12
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-07
• Last Update Posted: 2013-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
0.05% (w/w) CT327 ointment	CT327 0.05%	0.05% (w/w) CT327 ointment applied BID for up to 8 weeks.
0.1% (w/w) CT327 ointment	CT327 0.1%	0.1% (w/w) CT327 ointment applied BID for up to 8 weeks.
0.5% (w/w) CT327 ointment	CT327 0.5%	0.5% (w/w) CT327 ointment applied BID for up to 8 weeks.
Placebo ointment	Placebo	Placebo ointment

Primary Outcome Measures

Name	Time	Method
Efficacy of CT327 ointment (0.05%, 0.1% and 0.5% w/w) compared with placebo ointment.	Week 8

Secondary Outcome Measures

Name	Time	Method
Local and systemic toleration	8 weeks