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

NCT00379678 | Completed

• 2 other identifiers: HS-2042Novartis study #CASM981CUS39
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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 dermatitis.

Conditions

Atopic Dermatitis

Keywords

atopic dermatitis

Outcome Measures

Primary Outcomes (1)

• Information not available

  Information not available

Study Arms (1)

Information not available

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• National Jewish Health: lead

Study Sites (1)

National Jewish Medical and Research Center

Denver, Colorado, 80206, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Donald Leung, MD,PhD

  National Jewish Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 20, 2006
• First Posted: September 22, 2006
• Study Start: September 1, 2006
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: March 29, 2017

Record last verified: 2017-03

Locations

US (1)