A placebo controlled 4 week proof of concept study with 0.5% Roflumilast cream in patients with mild Atopic Dermatitis (RO-2351-001-EM)

Study identifier:RO-2351-001-EM

ClinicalTrials.gov identifier:NCT00746382

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Terminated/Withdrawn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 atopic dermatitis

Medical condition

dermatitis

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: Efficacy 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.
- 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

No locations available

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

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