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

Psoriasis Vulgaris Clinical Trial

Official title:

A Randomized, Placebo-controlled, Phase IIb Study to Evaluate the Efficacy, Safety and Tolerability of 0.05%, 0.1% and 0.5% w/w Topical CT327 When Applied Twice Daily in Subjects With Psoriasis Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01465282
• Other study ID #: CT327-2003
• Status: Completed
• Phase: Phase 2
• First received: November 1, 2011
• Last updated: March 7, 2013
• Start date: December 2011
• Est. completion date: September 2012

Study information

• Verified date: March 2013
• Source: Creabilis SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• CT327 0.05%
0.05% CT327 (w/w) ointment
• CT327 0.1%
0.1% CT327 (w/w) ointment
• CT327 0.5%
0.5% CT327 (w/w) ointment
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Creabilis SA

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of CT327 ointment (0.05%, 0.1% and 0.5% w/w) compared with placebo ointment.		Week 8	No
Secondary	Local and systemic toleration		8 weeks	No