Atopic DermatitisNCT00379678
Effects of Pimecrolimus on Skin Biopsy Ex-plants From Patients With Atopic Dermatitis
An observational study of Atopic Dermatitis, run by National Jewish Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Dermatitis
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Mar 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Jewish Medical and Research Center
Denver, Colorado, 80206
About this study
Official title: A Pilot Ex-vivo Study to Evaluate the Effect of Pimecrolimus on Antimicrobial Peptide Expression and Vaccinia Virus Growth in Perilesional Skin Cultures of Patients With Atopic Dermatitis
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.
Read the 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). AMP have been shown to have antibacterial activities against S. aureus (Ong 2002) and antiviral activity against vaccinia virus (VV) (Howell 2004).
The skin of AD patients is characterized by a deficiency in AMP, which may account for their propensity to skin infections (Ong 2002). This AMP deficiency is believed to be due to an increase in Th2 cytokines, IL-4 and IL-13, expression (Ong 2002), as well as an increase of IL-10 expression (Howell 2005). Other cytokines known to affect AMP expression are TNF-alpha (TNFa), IL-6, IL-1 and interferon-gamma (IFN-g). These cytokines induce the expression of AMP (Erdag 2002, Liu 2002, Ong 2002, Nomura 2003). However, negligible levels of TNF-a and IFN-g have been shown in AD skin possibly due to their downregulation by Th2 cytokines (Nomura 2003). Therefore, the neutralization of IL-4, IL-13 and IL-10 in AD patients may correct the AMP deficiency of AD patients and decrease their propensity to recurrent skin infections. Interestingly, the addition of anti-IL10 to skin explants from AD patients augmented HBD-2 and LL-37 expression (Howell 2005). In addition, IL-4 and IL-13 were found to enhance VV replication and down-regulate LL-37 in VV-stimulated keratinocytes and neutralization of IL-4/IL-13 in AD skin augmented LL-37 and inhibited VV replication (Howell 2006a). LL-37 and HBD-3 have been found to kill VV(Howell 2004; Howell 2006b). Thus a deficiency of these AMP may contribute to increased propensity to viral infection. Therapeutic strategies are needed to augment AMP expression in AD skin to reduce skin infection.
Pimecrolimus is a calcineurin inhibitor that binds with high affinity to macrophilin-12. The complex pimecrolimus-macrophilin inhibits calcineurin, a phosphatase required for the dephosphorylation of the cytosolic form of the nuclear factor of activated T cells (NF-AT). As a consequence, pimecrolimus prevents the nuclear translocation of NFAT and thereby the transcription and release of both Th1 and Th2 cytokines such as IL-2, IFN-g, IL-4, IL-5, IL-10, TNF-a and GM-CSF (Grassberger 1999).
As the most common topical corticosteroid treatment used by AD patients, triamcinolone diacetate is included in this study as an active comparator.
- Conditions
- Atopic Dermatitis
- Keywords
- atopic dermatitis
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Information not available | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Information not available
Measured: Information not available
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Investigators
- Donald Leung, MD,PhD, Principal investigator, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00379678
- Sponsor's protocol ID
- HS-2042
- Other IDs
- Novartis study #CASM981CUS39
- Status last verified
- Mar 2017
- First submitted
- 20 Sep 2006
- Last updated
- 29 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Ex-vivo Study to Evaluate the Effect of Pimecrolimus on Antimicrobial Peptide Expression and Vaccinia Virus Growth in Perilesional Skin Cultures of Patients With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT00379678
- Acronym / sponsor ID
- HS-2042
- Conditions
- Atopic Dermatitis
- Keywords
- atopic dermatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 22 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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). AMP have been shown to have antibacterial activities against S. aureus (Ong 2002) and antiviral activity against vaccinia virus (VV) (Howell 2004).
The skin of AD patients is characterized by a deficiency in AMP, which may account for their propensity to skin infections (Ong 2002). This AMP deficiency is believed to be due to an increase in Th2 cytokines, IL-4 and IL-13, expression (Ong 2002), as well as an increase of IL-10 expression (Howell 2005). Other cytokines known to affect AMP expression are TNF-alpha (TNFa), IL-6, IL-1 and interferon-gamma (IFN-g). These cytokines induce the expression of AMP (Erdag 2002, Liu 2002, Ong 2002, Nomura 2003). However, negligible levels of TNF-a and IFN-g have been shown in AD skin possibly due to their downregulation by Th2 cytokines (Nomura 2003). Therefore, the neutralization of IL-4, IL-13 and IL-10 in AD patients may correct the AMP deficiency of AD patients and decrease their propensity to recurrent skin infections. Interestingly, the addition of anti-IL10 to skin explants from AD patients augmented HBD-2 and LL-37 expression (Howell 2005). In addition, IL-4 and IL-13 were found to enhance VV replication and down-regulate LL-37 in VV-stimulated keratinocytes and neutralization of IL-4/IL-13 in AD skin augmented LL-37 and inhibited VV replication (Howell 2006a). LL-37 and HBD-3 have been found to kill VV(Howell 2004; Howell 2006b). Thus a deficiency of these AMP may contribute to increased propensity to viral infection. Therapeutic strategies are needed to augment AMP expression in AD skin to reduce skin infection.
Pimecrolimus is a calcineurin inhibitor that binds with high affinity to macrophilin-12. The complex pimecrolimus-macrophilin inhibits calcineurin, a phosphatase required for the dephosphorylation of the cytosolic form of the nuclear factor of activated T cells (NF-AT). As a consequence, pimecrolimus prevents the nuclear translocation of NFAT and thereby the transcription and release of both Th1 and Th2 cytokines such as IL-2, IFN-g, IL-4, IL-5, IL-10, TNF-a and GM-CSF (Grassberger 1999).
As the most common topical corticosteroid treatment used by AD patients, triamcinolone diacetate is included in this study as an active comparator.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Information not available | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Information not available
Time frame: Information not available
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
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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.
Donald Leung, MD,PhD principal investigator
National Jewish Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by National Jewish Health 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 5 inclusion and 14 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 29 Mar 2017. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Information not available (time frame: Information not available). 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 29 Mar 2017.