Dermatitis, AtopicPhase 4NCT00121381
Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis
A Phase 4 study testing Pimecrolimus plus topical corticosteroid (TCS) in people with Dermatitis, Atopic, run by Novartis at 13 sites in United States.
Trial summary
Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits the T-cell activation. These cells are involved in the inflammatory component of the disease. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- Pimecrolimus plus topical corticosteroid (TCS)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 13 sitesUnited States
- Study dates
- May 2005to Jan 2007
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Severe atopic dermatitis
- 5% of total body surface area (TBSA) affected
Who cannot join
- Concurrent skin diseases (infections)
- Immunocompromised
- Recently received phototherapy or systemic therapy
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Medical College of Georgia - Clinical Investigative Services
Augusta, Georgia, 30912
Dermatology Associates and Research
Coral Gables, Florida, 33134
520 Trinity Creek Cove
Cordova, Tennessee, 38018
National Jewish Medical and Research Center
Denver, Colorado, 80206
Calcagno Research and Development
Gresham, Oregon, 97030
Pediatric Care Medical Group, Inc.
Huntington Beach, California, 92647
Dartmouth Hitchcock Medical Center Section of Dermatology
Lebanon, New Hampshire, 03756
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Rhode Island Hospital
Providence, Rhode Island, 02903
Virginia Commonwealth University
Richmond, Virginia, 23298
Children's Hospital -San Diego
San Diego, California, 92123
A.S.T.H.M.A., Inc
Seattle, Washington, 98105
Wake Forest University School of Medicine Dept. of Dermatology
Winston-Salem, North Carolina, 27157
About this study
Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits the T-cell activation. These cells are involved in the inflammatory component of the disease. This study will test the safety of pimecrolimus Cream 1% with topical corticosteroid treatment (commonly used in eczema) in patients with severe atopic dermatitis.
- Conditions
- Dermatitis, Atopic
- Being tested
- Pimecrolimus plus topical corticosteroid (TCS), Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)
- Keywords
- Atopic dermatitis, T-cell, pimecrolimus, children, topical corticosteroids
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pimecrolimus plus topical corticosteroid (TCS)Drug
Also called Elidel
Pimecrolimus 1 % cream plus topical corticosteroid (TCS) twice daily
Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)Drug
twice daily administration
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Pimecrolimus 1 % cream plus topical corticosteroid (TCS) Receives: Drug: Pimecrolimus plus topical corticosteroid (TCS) |
| 2 | Placebo comparator | Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS) Receives: Drug: Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events of clinical interest (e.g. skin infections, skin irritation)
Secondary outcomes (5)
Incidence of all other adverse events
Time to relapse of atopic dermatitis
Time to treatment success according to the Investigators Global Assessment (IGA - a measure of disease severity)
Efficacy measured by IGA (treatment success and improvement)
Efficacy measured by improvement in Eczema Area and Severity Index (EASI - a measure of disease severity and extent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2005 (estimated)
- Study startMay 2005
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies 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
- 400 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
- NCT00121381
- Sponsor's protocol ID
- CASM981C2439
- Status last verified
- Jan 2008
- First submitted
- 14 Jul 2005
- Last updated
- 15 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT00121381
- Acronym / sponsor ID
- CASM981C2439
- Conditions
- Dermatitis, Atopic
- Keywords
- Atopic dermatitis, T-cell, pimecrolimus, children, topical corticosteroids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Study completion
- Jan 2007 (actual)
- First posted
- 21 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.
Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits the T-cell activation. These cells are involved in the inflammatory component of the disease. This study will test the safety of pimecrolimus Cream 1% with topical corticosteroid treatment (commonly used in eczema) in patients with severe atopic dermatitis.
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: Pimecrolimus plus topical corticosteroid (TCS)Pimecrolimus 1 % cream plus topical corticosteroid (TCS) |
| 2 | Placebo comparator | Drug: Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS) |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Severe atopic dermatitis
- 5% of total body surface area (TBSA) affected
Key exclusion criteria (3 listed)
- Concurrent skin diseases (infections)
- Immunocompromised
- Recently received phototherapy or systemic therapy
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 |
|---|---|---|
| Pimecrolimus plus topical corticosteroid (TCS)Also: ElidelPimecrolimus 1 % cream plus topical corticosteroid (TCS) twice daily | Drug | 1 |
| Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)twice daily administration | Drug | 2 |
Primary outcome
Incidence of adverse events of clinical interest (e.g. skin infections, skin irritation)
5 secondary outcomes
Incidence of all other adverse events
Time to relapse of atopic dermatitis
Time to treatment success according to the Investigators Global Assessment (IGA - a measure of disease severity)
Efficacy measured by IGA (treatment success and improvement)
Efficacy measured by improvement in Eczema Area and Severity Index (EASI - a measure of disease severity and extent
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 15 Jan 2008.
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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
13 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 plus topical corticosteroid (TCS) in people with Dermatitis, Atopic, run by Novartis at 13 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 2 inclusion and 3 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 15 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
Incidence of adverse events of clinical interest (e.g. skin infections, skin irritation). 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 15 Jan 2008.