Atopic DermatitisPhase 4NCT00124709
Safety and Efficacy of Pimecrolimus Cream 1% in Atopic Disease Modification
A Phase 4 study testing Pimecrolimus and Corticosteroid in people with Atopic Dermatitis, run by Novartis Pharmaceuticals at 36 sites in United States.
Trial summary
This study consists of a 3-year double-blind phase during which patients will receive atopic dermatitis (AD) treatment either with pimecrolimus cream 1% long-term management (LTM) or with a conventional corticosteroid-based treatment (1:1 ratio), followed by a 2 to 3-year open-label (OL) phase (all patients receiving… Read more about this study
- Who is it for?
- Ages 3 to 18 months
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Pimecrolimus and Corticosteroid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,091 participants
- Where
- 36 sitesUnited States
- Study dates
- Oct 2003to Nov 2008
- Phase
- Phase 4
- 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 3 to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of atopic dermatitis
- Family history of atopy
- 3 to 18 months of age at baseline
- At least mild atopic dermatitis at baseline (investigator global assessment [IGA] greater or equal to 2)
- Clinical evidence of atopic dermatitis for no longer than 3 months
Who cannot join
- Diagnosis of or substantial clinical evidence for food or other allergies at baseline
- Other protocol related criteria may apply
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
Dermatology, PLLC
Ann Arbor, Michigan, 48103
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Alabama Allergy and Asthma Center
Birmingham, Alabama, 35209
Children's Hospital - Boston
Boston, Massachusetts, 02115
Children's Memorial Hospital
Chicago, Illinois, 60614
Dermatology Associates and Research
Coral Gables, Florida, 33134
National Jewish Medical and Research Center
Denver, Colorado, 80206
Northwest Arkansas Pediatric Clinic, P.A.
Fayetteville, Arkansas, 72703
Calcagno Research and Development
Gresham, Oregon, 97030
Children's Medical Group
Hopewell Junction, New York, 12533
Texas Children's Hospital, BCM
Houston, Texas, 77030
Indiana University Outpatient Clinical Research
Indianapolis, Indiana, 46202
The Children's Clinic of Jonesboro
Jonesboro, Arkansas, 72401
Dartmouth-Hitchcock Medical Center/Dermatology Section
Lebanon, New Hampshire, 03756
Central Kentucky Research Associates
Lexington, Kentucky, 40509
Dermatology Specialists
Louisville, Kentucky, 40202
Rx R & D
Metarie, Louisiana, 70002
Southern California Research
Mission Viejo, California, 92691
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Dermatology Associates of St. Luke's - Roosevelt
New York, New York, 10025
Virginia Clinical Research
Norfolk, Virginia, 23507
Skin Specialists, P.C.
Omaha, Nebraska, 68144
Children's Hospital of Orange County
Orange, California, 92868
Emerald Coast Clinical Research
Pensacola, Florida, 32503
The Childrens' Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Oregon Health Science University - Dermatology Dept.
Portland, Oregon, 97201
Stanford Dermatology Clinic and Clinical Trials Dept
Redwood City, California, 94063
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Capital Allergy Respiratory Disease Center
Sacramento, California, 95819
Alpine Medical Group, LLC
Salt Lake City, Utah, 84102
Children's Hospital San Diego
San Diego, California, 92123
Asthma Inc
Seattle, Washington, 98105
Central Dermatology
St Louis, Missouri, 63117
Allergy and Asthma Medical Group of Diablo Valley, Inc./ Clinical Research Division
Walnut Creek, California, 94598
Granger Medical Clinic
West Valley City, Utah, 84120
About this study
Official title: An Investigation of the Safety and Efficacy of Elidel® 1% Cream in Atopic Disease Modification, Assessed in a 3-year Randomized Double-blind Vehicle Controlled Phase to Evaluate Effects on Atopic Dermatitis in Infants, and a 2-3 Year Open-label Phase to Evaluate the Effect of Early Intervention Versus Delayed Intervention With Elidel® on the Incidence of Asthma in Children
This study consists of a 3-year double-blind phase during which patients will receive atopic dermatitis (AD) treatment either with pimecrolimus cream 1% long-term management (LTM) or with a conventional corticosteroid-based treatment (1:1 ratio), followed by a 2 to 3-year open-label (OL) phase (all patients receiving pimecrolimus cream 1% LTM). At the end of the double-blind phase, the two treatment groups will be compared with respect to their efficacy in controlling AD; at the end of the OL phase, the incidence of asthma at the age of 6 years will be compared.
- Conditions
- Atopic Dermatitis
- Being tested
- Pimecrolimus, Corticosteroid
- Keywords
- Atopic, dermatitis, asthma, children, modification, Atopic dermatitis/atopy
- Medical subject headings
- Dermatitis, Atopic, Dermatitis, Asthma
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 %
CorticosteroidDrug
conventional corticosteroid-based treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Pimecrolimus Receives: Drug: Pimecrolimus |
| 2 | Active comparator | Corticosteroid Receives: Drug: Corticosteroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atopic Dermatitis (AD) Disease Control Over 36 Months
Proportion of disease-free days in Step 2 or less (per Patient) using total number of days in study as the denominator- double-blind phase. Intent to Treat Population: defined as all randomized patients who were dispensed study medication and had at least one post baseline efficacy measurement.
Measured: 36 months
Effect of Early Use of Pimecrolimus Cream 1% in Reducing the Incidence of Asthma at 6 Years of Age
Note: The results for this efficacy variable are not reported due to early termination of the study.
Measured: 6 years
Secondary outcomes (5)
Long Term Safety in Infants and Young Children
Note: The results of this secondary outcome is not reported due to early termination of the study.
Measured: 6 years
Incidence of Allergic Rhinitis, Allergic Conjunctivitis and Food Allergies
Percentage of Patients who had allergic rhinitis, allergic conjunctivitis and food allergies at the end of the 36 month double blind study.
Note: The results at six years are not reported due to early termination of the study.
Measured: 6 years (36 month Double-Blind Phase)
Corticosteroid and Pimecrolimus Drug Use
Corticosteroid and pimecrolimus study medication days of exposure during the 36 month double-blind phase.
Note: Although the double-blind phase was designed to be 36 months (3 years) in length, the last double-blind visit for some patients occurred after 36 months.
Measured: 48 months
Atopic Dermatitis (AD) Remission Time
Longest duration of atopic dermatitis (AD) remission during the 36 month double-blind treatment phase. A remission day was defined as a diary day with a positive response ("yes") to the question "No or almost no eczema?" and a response of no treatment except emollients to the question "Medication used".
Measured: 36 month Double-Blind Phase
Patient/Caregiver Quality of Life
Change from Baseline in the total Parents' Index of Quality of Life-Atopic Dermatitis (PIQoL-AD) score in the double-blind phase. PIQoL-AD Score = (sum of valid items/number of valid items) * 28. Scores range from a minimum value of 0 to a maximum value of 28 with a high total overall score indicating poor quality of life.
Measured: From Baseline to Visit 5 , 6, 8, 10, 12, and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2005 (estimated)
- Study startOct 2003
- Primary completionJan 2008
- Study completionNov 2008
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,091 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study chair, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00124709
- Sponsor's protocol ID
- CASM981CUS09
- Status last verified
- Feb 2011
- First submitted
- 26 Jul 2005
- Last updated
- 23 Mar 2011
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Spergel JM, Boguniewicz M, Schneider L, Hanifin JM, Paller AS, Eichenfield LF. Food Allergy in Infants With Atopic Dermatitis: Limitations of Food-Specific IgE Measurements. Pediatrics. 2015 Dec;136(6):e1530-8. doi: 10.1542/peds.2015-1444.
PubMed 26598458
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of the Safety and Efficacy of Elidel® 1% Cream in Atopic Disease Modification, Assessed in a 3-year Randomized Double-blind Vehicle Controlled Phase to Evaluate Effects on Atopic Dermatitis in Infants, and a 2-3 Year Open-label Phase to Evaluate the Effect of Early Intervention Versus Delayed Intervention With Elidel® on the Incidence of Asthma in Children
- ClinicalTrials.gov ID
- NCT00124709
- Acronym / sponsor ID
- CASM981CUS09
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic, dermatitis, asthma, children, modification, Atopic dermatitis/atopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1,091 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- Jan 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 28 Jul 2005 (estimated)
- Results
- Posted 23 Mar 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study consists of a 3-year double-blind phase during which patients will receive atopic dermatitis (AD) treatment either with pimecrolimus cream 1% long-term management (LTM) or with a conventional corticosteroid-based treatment (1:1 ratio), followed by a 2 to 3-year open-label (OL) phase (all patients receiving pimecrolimus cream 1% LTM). At the end of the double-blind phase, the two treatment groups will be compared with respect to their efficacy in controlling AD; at the end of the OL phase, the incidence of asthma at the age of 6 years will be compared.
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 | Active comparator | Drug: CorticosteroidCorticosteroid |
Who may qualify
- Ages
- 3 to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Diagnosis of atopic dermatitis
- Family history of atopy
- 3 to 18 months of age at baseline
- At least mild atopic dermatitis at baseline (investigator global assessment [IGA] greater or equal to 2)
- Clinical evidence of atopic dermatitis for no longer than 3 months
Key exclusion criteria (2 listed)
- Diagnosis of or substantial clinical evidence for food or other allergies at baseline
- Other protocol related criteria may apply
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 % | Drug | 1 |
| Corticosteroidconventional corticosteroid-based treatment | Drug | 2 |
Primary outcome
Atopic Dermatitis (AD) Disease Control Over 36 Months
Time frame: 36 months
Proportion of disease-free days in Step 2 or less (per Patient) using total number of days in study as the denominator- double-blind phase. Intent to Treat Population: defined as all randomized patients who were dispensed study medication and had at least one post baseline efficacy measurement.
Effect of Early Use of Pimecrolimus Cream 1% in Reducing the Incidence of Asthma at 6 Years of Age
Time frame: 6 years
Note: The results for this efficacy variable are not reported due to early termination of the study.
5 secondary outcomes
Long Term Safety in Infants and Young Children
Time frame: 6 years
Incidence of Allergic Rhinitis, Allergic Conjunctivitis and Food Allergies
Time frame: 6 years (36 month Double-Blind Phase)
Corticosteroid and Pimecrolimus Drug Use
Time frame: 48 months
Atopic Dermatitis (AD) Remission Time
Time frame: 36 month Double-Blind Phase
Patient/Caregiver Quality of Life
Time frame: From Baseline to Visit 5 , 6, 8, 10, 12, and 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26598458Spergel JM, Boguniewicz M, Schneider L, Hanifin JM, Paller AS, Eichenfield LF. Food Allergy in Infants With Atopic Dermatitis: Limitations of Food-Specific IgE Measurements. Pediatrics. 2015 Dec;136(6):e1530-8. doi: 10.1542/peds.2015-1444.
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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
36 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 and Corticosteroid in people with Atopic Dermatitis, run by Novartis Pharmaceuticals at 36 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 5 inclusion and 2 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: stopped early, as of the sponsor's last update on 23 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 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. 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?
Yes. Results are posted in the registry (first posted 23 Mar 2011). 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?
Atopic Dermatitis (AD) Disease Control Over 36 Months (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00124709, which also lists 1 linked publication.
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 23 Mar 2011.