Status:
COMPLETED
Quality of Life Study in Adults With Facial Eczema
Lead Sponsor:
Novartis
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study is not being conducted in the US. The study consists of a 4 week double blind treatment period. All patients meeting the inclusion/exclusion criteria will enter the study at day 0 and be r...
Eligibility Criteria
Inclusion
- Males and females aged 18 years or older
- Active Moderate Facial AE at baseline (Facial IGA score of 3), within 3 days of a deterioration in symptoms that necessitates further treatment.
- Diagnosis of AE fulfilling the diagnostic criteria of Williams (Williams, et al. 1994) outlined below: \*Must have an itchy skin condition plus 3 or more of the following 5 items listed below:
- History of involvement of the skin creases such as folds or elbows, behind the knees, fronts of ankles or around the neck;
- A personal history of asthma or hay fever;
- A history of a general dry skin in the last year;
- Visible flexural edema;
- Onset under the age of 2
- Pruritus score of 2 or above at baseline
- Patients in whom further use of TCS is clinically inappropriate due to:
- burning, stinging, allergic reaction or other adverse event that prevents the patient from using topical corticosteroids to successfully treat an AE flare on the face;
- presence of rosacea, telangiectasia, skin atrophy or glaucoma as a result of topical corticosteroid usage on the face;
- presence of AE on the eyelids Or patients where previous treatment has been unsatisfactory and who would prefer to try an alternative treatment option.
- Patients who have been informed of the study procedures and have signed the informed consent form approved for the study. (Informed consent should be signed as instructed in ICH-GCP and local regulations).
Exclusion
- At baseline and throughout the study, females of childbearing potential:
- Who are pregnant or breast-feeding
- Who are menstruating, capable of becoming pregnant, and not practicing a medically approved method of contraception during and up to at least 4 weeks after the end of study treatment. A negative pregnancy test (urine) for all females of childbearing potential is required at the screening visit. 'Medically approved' contraception may include abstinence at the discretion of the investigator
- At baseline and throughout the study, all patients:
- Who have received phototherapy (e.g. UVB, UVA) or systemic therapy (e.g. immunosuppressants, cytostatics) known or suspected to have an effect on AE within 1 month of Visit 1 (baseline)
- Who have received systemic corticosteroids (e.g. oral, intravenous, intra-articular, rectal) within 1 month of Visit 1. Patients on a stable maintenance dose of inhaled corticosteroids may participate
- Who have a known or suspected contact allergic dermatitis
- Who have received systemic antibiotics within 2 weeks prior to Visit 1.
- Who have used oral or topical antihistamines for the treatment of Pruritus within 2 weeks prior to visit 1
- Who have applied topical therapy (e.g. tar, topical corticosteroids, pimecrolimus or tacrolimus within 2 weeks prior to Screening
- Who have used potent or very potent TCS within 4 weeks prior to Visit 1.
- Who are immunocompromised (e.g. lymphoma, HIV infection/AIDS, Wiskott-Aldrich Syndrome) or have a history of malignant disease
- Who have a history of poor or no clinical response, or hypersensitivity to topical pimecrolimus cream 1%.
- Who have concurrent skin disease (e.g. acne) of such severity in the study area that it could interfere with the evaluation.
- Who have active bacterial (e.g. impetigo), viral (e.g. chicken pox, herpes simplex) or fungal infections (e.g. tinea corporis, intertriginosa)
- Who have received any investigational drugs within 8 weeks of visit 1, or plan to use any other investigational drugs during the course of this study
- Who, in the opinion of the investigator, are known to be unreliable, who are non-compliant with medical treatment, or are known to miss appointments
- Who have abuse problems, mental dysfunction or other factors limiting their ability to cooperate fully in study-related procedures
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2006
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00120302
Start Date
March 1 2005
End Date
January 1 2006
Last Update
January 17 2008
Active Locations (1)
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1
This study is not being conducted in the United States
Novartis Pharmaceuticals UK, Frimley, United Kingdom