Atopic DermatitisPhase 4NCT00117377
Effects of Pimecrolimus Cream 1% on the Molecular and Cellular Profile of Adult Male Patients With Atopic Dermatitis
A Phase 4 study testing Pimecrolimus in people with Atopic Dermatitis, run by Novartis at 3 sites in United States.
Trial summary
The purpose of this study is to identify how pimecrolimus cream 1% modifies the molecular and cellular changes associated with the post-lesional phase of atopic dermatitis (AD). Healthy volunteers and patients with atopic dermatitis will be studied. Read more about this study
- Who is it for?
- Ages 20 years and older, men onlyHealthy volunteers can take part
- 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
- 70 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2004to Jun 2005
- Phase
- Phase 4
- 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 20 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Outpatient at screening
- Adult male >20 years old
- Diagnosis of AD fulfilling the Hannifin and Rajka criteria
- Mild to moderate AD (Investigator Global Assessment [IGA] 2-3; localized eczema area and severity index [EASI] 1-8)
- AD affecting both arms and/or legs >10cm2 per target area
- Willing to undergo 4 mm serial punch biopsies
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- Patient history of AD for at least 3 years
- Volunteers must be males >20 years of age
- Volunteers must be in good health, as determined by past medical history, physical examination, and vital signs
Who cannot join
- Concurrent diseases/conditions and history of other diseases/conditions
- Are immunocompromised or have a history of malignant disease
- Have a history of rheumatic fever, heart valve replacement, prosthetic joints or other prosthetic constituents
- Have concurrent skin disease (e.g. acne) of such severity in the study area that it could interfere with the study evaluation
- Have previously reported poor or no clinical response to topical tacrolimus ointment (Protopic®) or pimecrolimus cream (Elidel®)
- Have active skin infections
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- Present with clinical conditions other than atopic dermatitis that can interfere with the study treatment
- Present with severe medical condition(s) that, in the opinion of the investigator, prohibits participation in the study
- Are maintained on emollients that contain supplementary ingredients such as urea, alpha or beta-hydroxy acids, fruit acids, vitamins A, D or E
- Have received phototherapy (e.g. UVA, UVB) or systemic therapy (e.g. immunosuppressants, cytostatics) known or suspected to have an effect on AD within 4 weeks of Visit 1 (screening)
- Have received systemic corticosteroids ([CS] e.g. oral, intravenous, intraarticular, rectal) within 4 weeks of Visit 1 (screening). Patients on a stable maintenance dose of inhaled or intranasal CS may participate
- Were treated with topical therapy, including topical calcineurin inhibitors (e.g. corticosteroids, tar) known or suspected to have an effect on AD during the current acute episode
- Were treated with antihistamines within 7 days of Visit 1
- Known serious adverse reactions or hypersensitivity to anesthetics such as lidocaine or mepivacaine
- Excluded investigational drugs/hypersensitivity
- Have received investigational drugs within 8 weeks of the first application of study drug or planned use of other investigational drugs during participation in this study
- Have known hypersensitivity to any ingredient of the pimecrolimus cream 1% or this class of study drug
- Erythrodermic patients, patients with Netherton's syndrome
- Personal or family history of atopy (asthma, allergic rhinitis, atopic dermatitis)
- Clinically significant findings during the physical examination
- Have a history of rheumatic fever, heart valve replacement, prosthetic joints or other prosthetic constituents e.g. lens implants or hip joints
- Volunteers with known serious adverse reactions or hypersensitivity to anesthetics such as lidocaine or mepivacaine
- Participation in any clinical trial within one month prior to current trial
- History of immunocompromise
- History of positive hepatitis B surface antigen (HBsAg) or hepatitis C test result
- Use of corticosteroids within 4 weeks prior to baseline
- Were treated with antihistamines within 7 days of Visit 1
- Phototherapy within 4 weeks prior to baseline
- Topical therapy within 5 weeks prior to the study
- Treatment with nephrotoxic drugs within 2 weeks prior to baseline (aminoglycosides, amphotericin B, colchicine)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mount Sinai School of Medicine
New York, New York
New York University Hospital
New York, New York
Virginia Clinical Research, Inc
Norfolk, Virginia
About this study
The purpose of this study is to identify how pimecrolimus cream 1% modifies the molecular and cellular changes associated with the post-lesional phase of atopic dermatitis (AD). Healthy volunteers and patients with atopic dermatitis will be studied.
- Conditions
- Atopic Dermatitis
- Being tested
- Pimecrolimus, Placebo
- Keywords
- Atopic dermatitis, pimecrolimus, cellular, molecular
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PimecrolimusDrug
Also called Elidel
Pimecrolimus cream 1 % bid
PlaceboDrug
Placebo application bid
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Pimecrolimus Receives: Drug: Pimecrolimus |
| 2 | Placebo comparator | Placebo control twice daily application Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining whether pimecrolimus cream has an effect on the cellular and molecular profile of atopic dermatitis skin, which is cleared of lesions and is otherwise clinically normal.
Secondary outcomes (1)
Identifying cellular and molecular changes in skin in an acute phase of atopic dermatitis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2005 (estimated)
- Study startApr 2004
- Study completionJun 2005
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study chair, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00117377
- Sponsor's protocol ID
- CASM981C2436
- Status last verified
- Dec 2007
- First submitted
- 30 Jun 2005
- Last updated
- 17 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pimecrolimus Cream 1% on the Molecular and Cellular Profile of Adult Male Patients With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT00117377
- Acronym / sponsor ID
- CASM981C2436
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, pimecrolimus, cellular, molecular
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Study completion
- Jun 2005 (actual)
- First posted
- 6 Jul 2005 (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 purpose of this study is to identify how pimecrolimus cream 1% modifies the molecular and cellular changes associated with the post-lesional phase of atopic dermatitis (AD). Healthy volunteers and patients with atopic dermatitis will be studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PimecrolimusPimecrolimus |
| 2 | Placebo comparator | Drug: PlaceboPlacebo control twice daily application |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Outpatient at screening
- Adult male >20 years old
- Diagnosis of AD fulfilling the Hannifin and Rajka criteria
- Mild to moderate AD (Investigator Global Assessment [IGA] 2-3; localized eczema area and severity index [EASI] 1-8)
- AD affecting both arms and/or legs >10cm2 per target area
Key exclusion criteria (30 listed)
- Concurrent diseases/conditions and history of other diseases/conditions
- Are immunocompromised or have a history of malignant disease
- Have a history of rheumatic fever, heart valve replacement, prosthetic joints or other prosthetic constituents
- Have concurrent skin disease (e.g. acne) of such severity in the study area that it could interfere with the study evaluation
- Have previously reported poor or no clinical response to topical tacrolimus ointment (Protopic®) or pimecrolimus cream (Elidel®)
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: ElidelPimecrolimus cream 1 % bid | Drug | 1 |
| PlaceboPlacebo application bid | Drug | 2 |
Primary outcome
Determining whether pimecrolimus cream has an effect on the cellular and molecular profile of atopic dermatitis skin, which is cleared of lesions and is otherwise clinically normal.
1 secondary outcome
Identifying cellular and molecular changes in skin in an acute phase of atopic dermatitis
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 17 Dec 2007.
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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.
Novartis Pharmaceuticals study chair
Novartis Pharmaceuticals
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pimecrolimus in people with Atopic Dermatitis, run by Novartis at 3 sites 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 9 inclusion and 30 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 17 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Determining whether pimecrolimus cream has an effect on the cellular and molecular profile of atopic dermatitis skin, which is cleared of lesions and is otherwise clinically normal.. 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 17 Dec 2007.