Status:
COMPLETED
Combination Therapy for Atopic Dermatitis
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
2-65 years
Phase:
PHASE4
Brief Summary
Atopic dermatitis is a chronic relapsing disease with acute flares. The standard therapy is to treat acute flares using topical medications. The two most common classes of topical medications for atop...
Detailed Description
This trial is a double-blind controlled trial of fluticasone cream daily and pimecrolimus cream BID versus fluticasone cream daily and placebo cream BID for the treatment of acute flares of atopic der...
Eligibility Criteria
Inclusion
- Age 2 to 65 years
- Clinical diagnosis of (Atopic Dermatitis) AD according to the American Academy of Dermatology (AAD) Consensus Conference (2001)
- At least two lesions of AD on symmetrical part of the body (same location for each side of the body), of severe intensity (m-EASI is at least 7 on each site, with erythema of at least 3 (severe) and papulation/infiltration of at least 3 (severe)) and similar severity (m-EASI does not differ from more than 2 points on both sides)
- Signed written informed consent
- Willingness and ability to comply with the study requirements
- Female is able to enter and participate in this study if she is of:
- Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) or
- Childbearing potential, has a negative pregnancy test (urine) at the screen visit and agrees to an adequate method of birth control throughout the study (which may, at the investigator's discretion, include abstinence)
Exclusion
- History of immune deficiencies or history of malignant disease
- Patients with moderate to severe lichenification at the target areas (i.e. score 2 or 3)
- Active cutaneous bacterial, viral or fungal infections in target areas
- History of other skin disorders, including Netherton syndrome, that could interfere with the evaluations
- Use of any topical treatment known or suspected to have an effect on atopic dermatitis within one week prior to the screen visit (except for calcineurin inhibitors, for which the washout is 2 weeks)
- Use of any systemic treatment (including phototherapy) known or suspected to have an effect on AD within four weeks prior to the screen visit \[(patients on a stable and low dose of inhaled steroids, on a stable dose of anti histamines, on stable dose of leukotriene antagonists, or receiving occasional short-acting b2-agonists for the treatment of asthma and topical corticosteroids (nasal spray) for the treatment of allergic rhinitis may participate). High-dose inhaled corticosteroids (\> 440 mcg of fluticasone a day) and anti-IgE products are not permitted\].
- Known sensitivity to pimecrolimus or vehicle (placebo) or fluticasone propionate cream or any of their ingredients
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
- Use of any other investigational agent in the last 30 days
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00119158
Start Date
October 1 2004
End Date
June 1 2005
Last Update
July 27 2010
Active Locations (3)
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1
National Jewish Research Medical Center
Denver, Colorado, United States, 80206
2
Northwestern University School of Medicine
Chicago, Illinois, United States, 60611
3
University of Texas at Houston Medical School
Houston, Texas, United States, 77030