A Placebo Controlled 4 Week Proof of Concept Study With 0.5% Roflumilast Cream in Patients With Mild Atopic Dermatitis (RO-2351-001-EM)

This study has been withdrawn prior to enrollment.
(Study withdrawn due to business decisions.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:
NCT00746382
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 atopic dermatitis in adults. This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study. 2-5 % of the body surface area (BSA) should be covered with a mild form of atopic dermatitis. In a 4-week treatment period 38 mg cream is applied two times daily on 0.5 to 1 % 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 antiinflammatory substance, a positive effect on this form of dermal disease is anticipated.


Condition Intervention Phase
Dermatitis
Drug: Roflumilast cream
Drug: Placebo cream
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy 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 Atopic Dermatitis

Resource links provided by NLM:


Further study details as provided by Nycomed:

Primary Outcome Measures:
  • Improvement of clinical signs and symptoms score, improvement of patient judged pruritus severity [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement of atopic dermatitis severity score, change in dermal questionaire, 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% versus Placebo cream
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.
  • Patients are suffering from mild, stable atopic dermatitis Male or female patient of any ethnic origin, age 18 years or older presenting a minimum of 2% to a maximum of 5% BSA affected by stable mild atopic dermatitis (IgE > 10)proven by a dermatologist.
  • Patients must have at least one target lesion of at least 0.5% BSA.
  • No evidence of oozing or crusting atopic dermatitis
  • No lichenification of diseased lesions
  • No excoriation of diseased lesions
  • Patients must be willing to wash out from current active therapy for at least 14 days 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 of birth control is defined at those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectable, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.

Exclusion Criteria:

  • Patient has spontaneously improving or rapidly deteriorating atopic dermatitis.
  • Patient has a physical condition which, in the Investigator´s opinion, might impair evaluation of atopic dermatitis or which exposes the patient to an unacceptable risk by study participation.
  • Patient had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to the initiation of treatment or is intending to have such exposure during the study that is thought by the Investigator likely to modify the patient´s disease.
  • The patient had topical or transdermal treatments, such as but not limited to retinoids, nicotine or hormone replacement therapies, on or near the intended site of application within 14 days prior to first application of study medication. Use of other topical preparations such as those containing vitamins, supplements or herbal within 14 days prior to application.
  • Treatment with systemic/locally acting medications/procedures which might counter or influence the study aim within 30 days before the start and during the study /e.g. anti-histamines, topical glucocorticosteroids, pimecrolimus , tacrolimus systematic desensitization)
  • Patient is pregnant, nursing or planning a pregnancy during the study period.
  • Patient has received an investigational drug or an investigational device within 30 days prior to study start.
  • 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: NCT00746382

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

No publications provided

Responsible Party: Exploratory Clinical Development, Nycomed
ClinicalTrials.gov Identifier: NCT00746382     History of Changes
Other Study ID Numbers: RO-2351-001-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 atopic dermatitis, Roflumilast cream 0.5%

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 29, 2014