N/A
Completed N=40
Effect of Pimecrolimus Cream on Cathelicidin Levels in Subjects With Eczema
Source: ClinicalTrials.gov NCT00946478 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcomePrimary: Cathelicidin mRNA Expression Levels in Adult Skin From Patients With AD — .0016; .0024 delta-delta ct units on PCR
Summary
The purpose of this study is to determine the effect of topical pimecrolimus on the immune system by assessing the levels of antimicrobial peptides in the skin of patients with eczema. It is hypothesized that pimecrolimus applied topically will repair the body's immune system in patients with eczema by increasing antimicrobial peptides.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cathelicidin mRNA Expression Levels in Adult Skin From Patients With AD |
.0016; .0024 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18-70 years
- Target lesion IGA ≥2
- Target IGA=0 (for non-lesional site)
- Male or female of any race and ethnicity
- Chronic AD for more than one year duration
- Subject of child-bearing potential must be willing to practice effective birth control during the study
- Subject agrees to comply with study requirements and attend all required visits.
Exclusion Criteria
- Patients ≥ 18 years of age with only AD of the face
- Women of childbearing potential not using the contraception method(s) specified in this study (abstinence, IUD, diaphragm, oral contraceptives)
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
- Hypersensitivity to pimecrolimus cream or any excipient of the cream
- Subject has a skin disorder in addition to dermatitis in the areas to be treated
- Subject has Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier
- Pregnant or nursing females
- Immunocompromised patient (e.g., lymphoma, HIV/AIDS, Wiskott-Aldrich Syndrome), or with a history of active or malignant disease (excluding non-melanoma skin cancer)
- History of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol
- Patients known to be non-compliant with a medication regimen
- Subjects with significant concurrent medical condition(s) at screening that in the view of the investigator prohibits participation in the study (e.g., severe concurrent allergic disease, condition associated with malignancy, and condition associated with immunosuppression)
- Active viral or fungal skin infections at the target areas
- Previous participation in this study
- Ongoing participation in another investigational trial
- Use of any oral or topical antibiotic during the study and up to one week prior to entering the study
- Use of any local therapy for AD less than one week prior to screening
- Use of any systemic immunosuppressive therapy for AD less than four weeks prior to screening.
Data sourced from ClinicalTrials.gov (NCT00946478). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.