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Atopic DermatitisPhase 4NCT00139581

Comparison of Pimecrolimus Cream 1% Twice-Daily to Once-Daily Dosing in the Management of Atopic Dermatitis in Pediatric Subjects

A Phase 4 study testing Pimecrolimus in people with Atopic Dermatitis, run by Novartis at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is not being conducted in the United States. To investigate the relative efficacy of pimecrolimus cream 1% applied twice daily (b.i.d.) versus once daily (o.d.) in preventing the progression to disease "relapse". Read more about this study

Who is it for?
Ages 2 to 17 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
Pimecrolimus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
Not given
Where
1 siteSwitzerland
Study dates
Sep 2004to Sep 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 2 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • age >= 2 years through age <=17 years of age
  • IGA score of 2, 3, or 4 (mild, moderate, or severe AD) affecting >5% TBSA
  • outpatients

Who cannot join

  • subjects who applied topical therapy (e.g. tar, topical corticosteroids) within 2 weeks prior to Screening
  • subjects who received phototherapy (e.g. UVB, PUVA, Narrow Band) within 4 weeks of Screening
  • subjects who received any systemic immunosuppressant
  • subjects who received systemic steroids
  • females who are pregnant or breast-feeding, or planning to become pregnant during the study
  • subjects who are immunocompromised (e.g. lymphoma, AIDS, Wiskott-Aldrich syndrome) or have a history of malignancy (includes basal cell carcinoma, squamous cell carcinoma, melanoma)
Show all 29Show fewer
  • subjects with open skin infections (bacterial, viral or fungal) if at the application site.
  • subjects will HSV (common cold sores) are allowed to participate in the study (if not at the application site).
  • subjects who have head lice or scabies
  • subjects who present with clinical conditions other than AD that may interfere with the evaluation (e.g., generalized erythroderma, acne, Netherton's Syndrome,psoriasis)
  • subjects that require systemic therapy for the treatment of atopic dermatitis
  • subjects with poor or no clinical response to tacrolimus ointment (Protopic®) or pimecrolimus cream 1%
  • subjects who used any experimental or investigational drug or therapy within 6 weeks prior to Screening
  • subjects who intend to use experimental or investigational drug therapy during the course of this study
  • subjects with known hypersensitivity to pimecrolimus 1% or related drugs (see Investigator's Brochure)
  • subjects who are non-compliant with general medical treatment, or are known to miss appointments, or don't intend to comply with the protocol for the duration of the study
  • drug abuse, mental dysfunction, or other factors limiting the subject's ability to cooperate fully with study-related procedures
  • subjects known to be unreliable or may be unable to complete the study
  • any condition or prior/present treatment that would render the subject ineligible for the study
  • Inclusion criteria - Double-blind Maintenance treatment period
  • Achieve complete remission of active disease (no signs or symptoms of AD) without incidence of "relapse" by the end of 6-week Run-In period (may be earlier); or who achieve "disease improvement" (decrease in IGA score by 1 full point confirmed by the investigator) without incidence of relapse at the end of the 6-week Run-In period
  • Exclusion criteria - Double-blind Maintenance treatment period
  • subjects who experienced a "relapse" during the Run-In period
  • subjects who applied topical corticosteroids or any alternative or additional therapy for the treatment of AD during the Run-In period
  • subjects with active skin infections (bacterial, viral or fungal) except common cold sores (HSV) at the application site
  • subjects who failed to record study medication use (and non use) and dosing regimen during the Run-In period
  • subjects who failed to apply open label study drug twice daily until "disease remission" or end of the 6 week Run-In period
  • subjects who failed to record concomitant medications during the Run-In period
  • failure to return open-label study drug (used, partially used, and unused tubes) at the time double-blind study drug is dispensed. In order to avoid medication error, all open label study drug must be returned to the site before starting the Maintenance period

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • This study is not being conducted in the United States

    Novartis Pharma AG, Basel

Other trials in Switzerland

About this study

This study is not being conducted in the United States.

To investigate the relative efficacy of pimecrolimus cream 1% applied twice daily (b.i.d.) versus once daily (o.d.) in preventing the progression to disease "relapse".

Being tested
Pimecrolimus
Keywords
Atopic dermatitis, children, infants, pimecrolimus, bid, od
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 b.i.d.

    Pimecrolimus cream 1 % applied twice daily (b.i.d.)

  • PimecrolimusDrug

    Also called Elidel o.d.

    Pimecrolimus cream 1 % applied once daily (o.d.) and placebo applied once daily (o.d.)

Study groups in NCT00139581
Study groupRoleWhat they receive
1ExperimentalPimecrolimus b.i.d.
Receives: Drug: Pimecrolimus
2ExperimentalPimecrolimus o.d. and placebo o.d.
Receives: Drug: Pimecrolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to relapse of atopic dermatitis (defined as the exacerbation of atopic dermatitis to the level where a topical corticosteroid or alternative therapy is required).

  2. Investigators Global Assessment (IGA) and pruritus (itch) assessment of atopic dermatitis at time of suspected relapse

Secondary outcomes (2)

  1. Time to first recurrence of atopic dermatitis

  2. Eczema Area and Severity Index (EASI) and IGA assessments at several time points.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2005 (estimated)
  2. Study startSep 2004
  3. Study completionSep 2005

Resources

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
IDs, dates and publications
ClinicalTrials.gov ID
NCT00139581
Sponsor's protocol ID
CASM981C2314
Status last verified
Apr 2008
First submitted
30 Aug 2005
Last updated
23 Apr 2008
Results posted
No

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 1 site in Switzerland.

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 3 inclusion and 29 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 23 Apr 2008. 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 Switzerland. 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?

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?

Time to relapse of atopic dermatitis (defined as the exacerbation of atopic dermatitis to the level where a topical corticosteroid or alternative therapy is required).. 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 NCT00139581.

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 Apr 2008.

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