CT 327 in the Treatment of Psoriasis Vulgaris

NCT00995969 | Completed Phase 2

• 1 other identifier: CT 327 PV 01-09
• Study Type: interventional
• Target: 58
• Locations: 3 countries
• Sites: 12

Brief Summary

This study will look at how safe and effective, a novel agent, CT 327 cream is in treating patients with mild to moderate psoriasis vulgaris (PV). Patients will be treated twice daily for 8 weeks on specific lesions of PV and safety and symptoms of PV will be assessed throughout the treatment period.

Conditions

Psoriasis

Keywords

Mild to moderate psoriasis vulgaris

Outcome Measures

Primary Outcomes (1)

• Improvements from baseline on m-Psoriasis Area Severity Index Scale (m-PASI - modified to exclude area assessment): Proportion of subjects with a reduction in score of > 50% at Week 8

  8 weeks

Secondary Outcomes (1)

• To assess the efficacy of an 8-week treatment of CT 327 vs Placebo in terms of improvements from baseline on: Proportion of subjects with a reduction in m-PASI-score of > 75% a Week 8

  8 weeks

Study Arms (2)

Placebo only

PLACEBO COMPARATOR

Subjects will apply placebo cream to both target lesions

Drug: placebo

Active plus placebo

ACTIVE COMPARATOR

Subjects will apply CT 327 to one target lesion and placebo to the other target lesion

Drug: CT 327

Interventions

placebo DRUG

1.0 g (w/w) placebo cream applied to both target lesions twice daily

Placebo only

CT 327 DRUG

1.0 g CT 327 cream will be applied to one target lesion twice daily and 1.0 g placebo cream will be applied to the remaining target lesion twice daily

Active plus placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 and \< 71 years of age
• Able to give informed consent
• Diagnosis of mild (affecting \< 3% BSA) to moderate (affecting \< 10% BSA) Psoriasis Vulgaris, including, at baseline visit, two symmetrical lesions of at least 10 cm2 each

You may not qualify if:

• If female of childbearing potential not using an adequate and appropriate form of contraception such as oral contraceptive; intra-uterine device (IUD); contraceptive injection, implant or patch
• If female, are pregnant or lactating, or intend to become pregnant during the study period and one month thereafter
• Allergy to test drug or excipients
• Usage of topical corticosteroids or other topical treatments for PV within the last two weeks prior to study entry (including calcineurin inhibitor, topical H1 antihistamines, topical antimicrobials, other medicated topical agents) or herbal preparation to the area selected for treatment Within 4 weeks prior to study entry, have received systemic treatment for psoriasis (including systemic corticosteroids, nonsteroidals, immunosuppressants, or immunomodulating drugs, or treatment with light).
• Received treatment with systemic or locally acting medications which might counter or influence the study aim
• Presence of major medical illness requiring systemic therapy including cancers
• Clinical diagnosis of bacterial infection of the skin including impetigo and abscesses
• Any clinical relevant ECG abnormality
• Have any clinically significant abnormal clinical laboratory test results at screening
• Received any investigational drug or taking part in any clinical study within three months prior to this study
• History of drug, alcohol or other substance abuse or other factors limiting the ability to co-operate and to comply with this protocol
• Have concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug
• Have immune-compromised status (such as known human immunodeficiency virus infection)
• Have a history of malignancy, excluding basal cell carcinoma of the skin
• Have an active intercurrent infection

Sponsors & Collaborators

• Creabilis SA: lead

Study Sites (12)

Metrolina Medical Research

Charlotte, North Carolina, 28209, United States

Location

New Hanover Medical Research

Wilmington, North Carolina, 28401, United States

Location

Piedmont Medical Research, LLC

Winston-Salem, North Carolina, 27103, United States

Location

Premier Medical Group, P.C.

Clarksville, Tennessee, 37040, United States

Location

East Tennessee Medical Research

Johnson City, Tennessee, 37604, United States

Location

University Hospital

Basel, CH-4031, Switzerland

Location

Inselspital

Bern, 3010, Switzerland

Location

Kantonsspital

Sankt Gallen, CH-9007, Switzerland

Location

University Hospital

Zurich, CH-8091, Switzerland

Location

Synexus Midlands

Birmingham, Midlands, B15 2SQ, United Kingdom

Location

Synexus Scotland

Clydebank, Strathclyde, G81 2DR, United Kingdom

Location

Synexus Wales

Cardiff, CF14 5GJ, United Kingdom

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 15, 2009
• First Posted: October 16, 2009
• Study Start: March 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: February 10, 2011

Record last verified: 2011-02

Locations

US (5); CH (4); GB (3)