Effects of Pimecrolimus on Skin Biopsy Ex-plants From Patients With Atopic Dermatitis

Completed

Conditions studied: Atopic Dermatitis

In brief

THe study seeks to determine if pimecrolimus has a positive effect on increasing antimicrobial peptide expression and reducing vaccinia virus growth in the skin explants from patients with atopic dermatitis.

Key facts

Study ID

NCT00379678

Run by

National Jewish Health

People needed

28

Starts

2006-09-01

Expected to finish

2007-03-01

Last updated by the study team

2017-03-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has signed the informed consent form
• Male or female of any race and ethnicity
• Patient is 18 years of age or older with active AD
• Active AD of any severity will be defined according to Hanifin and Rajka clinical criteria (Hanifin, J.M., Rajka, G. 1980)
• Chronic AD for more than one year duration

You may not qualify if…

• Patients with only AD of the face
• Women of childbearing potential not using the contraception method(s) specified in this study (abstinence, oral contraceptives, IUD,diaphragm), as well as women who are breastfeeding
• 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
• Patient who is pregnant or lactating
• Patient using oral corticosteroids, or any systemic immunosuppressive, or immunomodulary medication within the last 28 days
• Patient who has received immunotherapy within the last year
• Patient with a history of bleeding disorders
• Use of aspirin, oral antihistamines, oral antibiotics, oral cyclosporine, or topical medications within seven days of the Screening/Baseline Visit including (but not restricted to), Elidel, Protopic, topical corticosteroids, and topical antibiotics
• Patients with known lidocaine allergy
• Inability of patient to follow study procedures or documented history of the patient being noncompliant
• Any concomitant diagnosis that, in the opinion of the investigator, might impact the biopsy procedure
• Infected AD
• Use of any topical medication < 7 days or systemic medication < one month prior to study start

Where it is running

• National Jewish Medical and Research Center — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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