Atopic DermatitisNCT00946478
Effect of Pimecrolimus Cream on Cathelicidin Levels in Subjects With Eczema
A study testing Pimecrolimus in people with Atopic Dermatitis, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Pimecrolimus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to May 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego - Dept of Dermatology
La Jolla, California, 92037
About this study
Official title: A Three-week, Double-blind, Randomized Study to Evaluate the Effect of Pimecrolimus Cream 1% on Cathelicidin Expression in the Skin of Subjects With Atopic Dermatitis
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.
Read the detailed description
Patients with atopic dermatitis (AD) have higher rates of skin infections from viruses and bacteria. They also have an impaired innate immune system. Antimicrobial peptides are a component of the innate immune system which are decreased in atopics. In vitro, pimecrolimus has demonstrated its ability to increase antimicrobial peptides. This study will examine the ability of pimecrolimus to increase antimicrobial peptides in vivo in AD patients. Thus, the study will yield a better understanding of the role of pimecrolimus in regulating the immune system in atopics.
- Conditions
- Atopic Dermatitis
- Being tested
- Pimecrolimus, Vehicle cream
- Keywords
- atopic dermatitis, elidel, pimecrolimus, CASM981, immunity, cathelicidin, antimicrobial peptide, eczema
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PimecrolimusDrug
Also called Elidel, CASM 981
20 AD patients will be given pimecrolimus 1% to apply twice daily for up to three weeks on each lesional site predetermined at baseline. Lesional target site and non-lesional site will be determined at Visit 1.
Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit).
Vehicle creamOther
20 AD patients will be treated with vehicle cream twice daily for up to 3 weeks on each lesional site predetermined at baseline. Lesional target site and non-lesional site will be determined at Visit 1.
Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit).
| Study group | Role | What they receive |
|---|---|---|
| Pimecrolimus | Active comparator | Not described Receives: Drug: Pimecrolimus |
| Vehicle cream | Sham comparator | Not described Receives: Other: Vehicle cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cathelicidin mRNA Expression Levels in Adult Skin From Patients With AD
Delta-delta CT values were measured using RT-PCR of cathelicidin mRNA in human biopsy samples at baseline, and then 3 weeks after treatment with either pimecrolimus or placebo
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2009 (estimated)
- Study startOct 2009
- Primary completionFeb 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Richard Gallo, University of California, San Diego
- Investigators
- Richard Gallo, MD, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00946478
- Sponsor's protocol ID
- UCSDMED
- Status last verified
- Jan 2014
- First submitted
- 24 Jul 2009
- Last updated
- 10 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three-week, Double-blind, Randomized Study to Evaluate the Effect of Pimecrolimus Cream 1% on Cathelicidin Expression in the Skin of Subjects With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT00946478
- Acronym / sponsor ID
- UCSDMED
- Conditions
- Atopic Dermatitis
- Keywords
- atopic dermatitis, elidel, pimecrolimus, CASM981, immunity, cathelicidin, antimicrobial peptide, eczema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Oct 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 27 Jul 2009 (estimated)
- Results
- Posted 10 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients with atopic dermatitis (AD) have higher rates of skin infections from viruses and bacteria. They also have an impaired innate immune system. Antimicrobial peptides are a component of the innate immune system which are decreased in atopics. In vitro, pimecrolimus has demonstrated its ability to increase antimicrobial peptides. This study will examine the ability of pimecrolimus to increase antimicrobial peptides in vivo in AD patients. Thus, the study will yield a better understanding of the role of pimecrolimus in regulating the immune system in atopics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pimecrolimus | Active comparator | Drug: Pimecrolimus |
| Vehicle cream | Sham comparator | Other: Vehicle cream |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PimecrolimusAlso: Elidel, CASM 98120 AD patients will be given pimecrolimus 1% to apply twice daily for up to three weeks on each lesional site predetermined at baseline. Lesional target site and non-lesional site will be determined at Visit 1. Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit). | Drug | Pimecrolimus |
| Vehicle cream20 AD patients will be treated with vehicle cream twice daily for up to 3 weeks on each lesional site predetermined at baseline. Lesional target site and non-lesional site will be determined at Visit 1. Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit). | Other | Vehicle cream |
Primary outcome
Cathelicidin mRNA Expression Levels in Adult Skin From Patients With AD
Time frame: 3 weeks
Delta-delta CT values were measured using RT-PCR of cathelicidin mRNA in human biopsy samples at baseline, and then 3 weeks after treatment with either pimecrolimus or placebo
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Gallo, MD, PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pimecrolimus in people with Atopic Dermatitis, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cathelicidin mRNA Expression Levels in Adult Skin From Patients With AD (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2014.