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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00746434
Recruitment Status : Withdrawn (Study withdrawn due to business decisions. No subjects were treated.)
First Posted : September 4, 2008
Last Update Posted : December 5, 2016
Fougera Pharmaceuticals Inc.
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Plaque Psoriasis Drug: Roflumilast cream Drug: Placebo cream Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Proof of Concept Study With 0.5% Roflumilast Cream in Patients With Mild to Moderate Plaque Psoriasis
Study Start Date : November 2008
Estimated Primary Completion Date : June 2009
Estimated Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Roflumilast

Arm Intervention/treatment
Active Comparator: 1
Roflumilast cream 0.5%
Drug: Roflumilast cream
Roflumilast cream 0.5%

Placebo Comparator: 2
Placebo cream
Drug: Placebo cream
Placebo cream

Primary Outcome Measures :
  1. Improvement of clinical signs and symptoms score [ Time Frame: 28 days ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00746434

Sponsors and Collaborators
Fougera Pharmaceuticals Inc.
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Study Director: AstraZeneca AstraZeneca AstraZeneca
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Responsible Party: AstraZeneca Identifier: NCT00746434    
Other Study ID Numbers: RO-2351-002-EM
First Posted: September 4, 2008    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: October 2016
Keywords provided by AstraZeneca:
Mild plaque psoriasis,
Moderate plaque psoriasis,
0.5% Roflumilast cream
Additional relevant MeSH terms:
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Skin Diseases, Papulosquamous
Skin Diseases