Status:
COMPLETED
Effects of Pimecrolimus on Skin Biopsy Ex-plants From Patients With Atopic Dermatitis
Lead Sponsor:
National Jewish Health
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-65 years
Brief Summary
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 derm...
Detailed Description
AMP play an important role in the innate immune response against infections. Two major classes of AMP have been identified: the beta defensins (HBD) (Harder 1997) and cathelicidins (LL-37) (Gallo 2002...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00379678
Start Date
September 1 2006
End Date
March 1 2007
Last Update
March 29 2017
Active Locations (1)
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1
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206