A Proof of concept study with 0.5% Roflumilast cream in patients with mild to moderate plaque Psoriasis

Study identifier:RO-2351-002-EM

ClinicalTrials.gov identifier:NCT00746434

EudraCT identifier:N/A

CTIS identifier:N/A

Terminated/Withdrawn

Official Title

A proof of concept study with 0.5% Roflumilast cream in patients with mild to moderate plaque Psoriasis

Medical condition

Plaque psoriasis

Phase

Phase 2

Healthy volunteers

Study drug

Roflumilast cream, Placebo cream

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 01 Nov 2008

Estimated Primary Completion Date: 01 Jun 2009

Estimated Study Completion Date: 01 Sept 2009

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Oct 2016 by AstraZeneca

Collaborators

Nycomed US Inc.

Inclusion and exclusion criteria

Inclusion Criteria

- Patient (who is able to read, to write and to fully understand English language) has been informed both verbally and in writing about the objectives of the clinical study, the methods, the anticipated benefits and potential risks and the discomfort to which he/she may be exposed, and has given written consent to participation in the study prior to study start and any study-related procedure.
- Patient is suffering from mild to moderate plaque psoriasis
- Male or female patient of any ethnic origin, age 18 years or older presenting a minimum of 3% to a maximum of 10% BSA affected by mild to moderate plaque psoriasis proven by a dermatologist.
- Patient must have a minimum of 1 and a maximum of 3 in severity score of psoriasis
- Patient must have at least one target lesion of at least 1% BSA.
- Patient must be willing to wash out from current active therapy for at least 14 days prior to Day 1.
- Women of childbearing potential must have a negative pregnancy test at the Screening and Baseline Visits and agree to use a highly effective method of birth control. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner

Exclusion Criteria

- Patient has spontaneously improving or rapidly deteriorating plaque psoriasis within at least the past 3 month.
- Patients who have a known history of psoriasis unresponsive to topical treatments.
- Patient has a physical condition (e.g., atopic dermatitis, contact dermatitis, tinea corporis) which, in the Investigator's opinion, might impair evaluation of plaque psoriasis or which exposes the patient to an unacceptable risk by trial participation.
- Clinically relevant abnormal laboratory values and vital signs suggesting an unknown underlying disease and requiring further clinical evaluation (as assessed by the Investigator).
- Patient is pregnant, nursing or planning a pregnancy during the trial period.
- Patient is currently enrolled in an investigational drug or device trial.
- Patient has received an investigational drug or an investigational device within 30 days prior to trial start.
- Patient has a history of allergic reactions to roflumilast or any inactive ingredients of the trial medication.
- Patient has positive results in any of the virology tests of acute or chronic infectious HIV and hepatitis virus infections.
- Abuse of alcohol or drugs

No locations available

Arms	Assigned Interventions
Active Comparator: 1 Roflumilast cream 0.5%	Drug: Roflumilast cream Roflumilast cream 0.5%
Placebo Comparator: 2 Placebo cream	Drug: Placebo cream Placebo cream

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

AstraZeneca AstraZeneca

AstraZeneca