A Proof of Concept Study With 0.5% Roflumilast Cream in Patients With Mild to Moderate Plaque Psoriasis

This study has been withdrawn prior to enrollment.
(Study withdrawn due to business decisions. No subjects were treated.)
Sponsor:
Collaborator:
Fougera Pharmaceuticals Inc.
Information provided by:
Nycomed
ClinicalTrials.gov Identifier:
NCT00746434
First received: September 3, 2008
Last updated: May 4, 2012
Last verified: May 2012
  Purpose

The aim of this proof of concept study is to show the safety and efficacy of 0.5 % dermal roflumilast cream in the treatment of plaque psoriasis in adults. This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study. 3-10 % of the body surface area (BSA) should be covered with a mild to moderate form of plaque psoriasis. In a 4-week treatment period 76 mg cream is applied two times daily on up to 2% of the BSA. After a screening phase, a washout phase of flexible duration (max 30 days, time depending upon pre-medication), the 28 day treatment phase follows. As roflumilast is a potent anti-inflammatory substance, a positive effect on this form of dermal disease is anticipated.


Condition Intervention Phase
Plaque Psoriasis
Drug: Roflumilast cream
Drug: Placebo cream
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Proof of Concept Study With 0.5% Roflumilast Cream in Patients With Mild to Moderate Plaque Psoriasis

Resource links provided by NLM:


Further study details as provided by Nycomed:

Primary Outcome Measures:
  • Improvement of clinical signs and symptoms score [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement of plaque psoriasis severity score, improvement of patient judged pruritus severity, change in dermal questionnaire, safety and efficacy [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: November 2008
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746434

Sponsors and Collaborators
Nycomed
Fougera Pharmaceuticals Inc.
Investigators
Study Chair: Nycomed Exploratory Clinical Development Headquarters
  More Information

No publications provided

Responsible Party: Exploratory Clinical Development, Nycomed
ClinicalTrials.gov Identifier: NCT00746434     History of Changes
Other Study ID Numbers: RO-2351-002-EM
Study First Received: September 3, 2008
Last Updated: May 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Nycomed:
Mild plaque psoriasis,
Moderate plaque psoriasis,
0.5% Roflumilast cream

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on July 26, 2014