Atopic DermatitisPhase 3NCT00120523

5-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 - 12 Months of Age With Mild to Moderate Atopic Dermatitis

A Phase 3 study testing Pimecrolimus and Topical corticosteroids in people with Atopic Dermatitis, run by MEDA Pharma GmbH & Co. KG at 31 sites in 2 countries.

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

The primary purpose of this study is to investigate the safety of pimecrolimus cream 1% in the long-term treatment (up to 5 years) of atopic dermatitis (eczema) in patients less than 12 months of age compared to topical corticosteroids (TCS). Read more about this study

Who is it for?: Ages 3 to 12 months
Conditions the study is for: Atopic Dermatitis
What is being tested?: Pimecrolimus and Topical corticosteroids
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,418 participants
Where: 31 sitesin 2 countries
Study dates: Apr 2004to Oct 2010
Phase: Phase 3
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 12 months
All sexes
No healthy volunteers
Child

Who may be able to join

Aged 3 to < 12 months
Diagnosis of AD fulfilling the diagnostic criteria of Seymour
AD affecting at least 5% total body surface area
Investigator's Global Assessment (IGA) score of 2 or 3, corresponding to mild-to-moderate disease at baseline
Informed consent

Who cannot join

Phototherapy, systemic therapy (e.g., immunosuppressants, cytostatics), systemic corticosteroids within 4 weeks
Topical tacrolimus or pimecrolimus within 2 weeks
Topical therapy (e.g., tar, topical corticosteroids) within 3 days
Immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have a history of malignant disease
Active acute viral skin infection (e.g. herpes simplex, herpes zoster, chicken pox), and/or clinically infected AD
Failure to thrive (e.g., weight or height/length below the 5th percentile) or developmental abnormalities such as head circumference less than 5th and more than 95th percentile
Known hypersensitivity to any ingredient of pimecrolimus cream 1% or topical corticosteroids
Clinical conditions other than AD that according to investigator can interfere with the evaluation

Trial locations and contacts

31 sites in 2 countries.

Country

City, postcode or hospital

31 sites in 2 countries

United States30 sites

The Portland Clinic
Beaverton, Oregon, 97006
9540 Artesia Blvd., Suite #1
Bellflower, California, 90706
Radiant Research
Bridgeton, Missouri, 63044
Allergy & Asthma Consultants, LLP
Charleston, South Carolina, 29414
Dermatology Research Associates
Cincinnati, Ohio, 245230
Wayne State University Dermatology
Detroit, Michigan, 48201
SMDC Health System
Duluth, Minnesota, 55805
Allergic Disease and Asthma Center
Greenville, South Carolina, 29607
Calcagno Research and Development
Gresham, Oregon, 97030
Suzanne Bruce& Associates, PA
Houston, Texas, 77056
Ohio Pediatrics, Inc.
Huber Heights, Ohio, 45424
Pediatric Care Medical Group, Inc.
Huntington Beach, California, 92647
Michigan State University - Kalamazoo Center for Med Studies
Kalamazoo, Michigan, 49008
Arkansas Pediatric Clinic
Little Rock, Arkansas, 72205
Little Rock Allergy & Asthma Clinic
Little Rock, Arkansas, 72205
Longmont Clinical Research
Longmont, Colorado, 80501
University of Tennessee - Dept. of Pediatrics
Memphis, Tennessee, 38105
Children's Skin Center
Miami, Florida, 33155
Dermatology Center for Children
Minneapolis, Minnesota, 55404
University of Minnesota - Dept. of Dermatology
Minneapolis, Minnesota, 55455
Pediatric Research Center of South Florida
Palm Beach Gardens, Florida, 33458
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Capitol Pediatrics & Adolescent Center
Raleigh, North Carolina, 27609
Virginia Commonwealth University
Richmond, Virginia, 23298
Dermatology Associates of Rochester, P.C.
Rochester, New York, 14623
AeroAllergy Research Laboratories of Savanah, Inc.
Savannah, Georgia, 31406
The Pediatric Center
Stone Mountain, Georgia, 30083
Grand Parkway Pediatrics
Sugar Land, Texas, 77479
Cholla Pediatrics
Tucson, Arizona, 85741
Respiratory Medicine Research Institute of Michigan
Ypsilanti, Michigan, 48197

Other trials in United States

Germany1 site

Novartis
Investigative Site

Other trials in Germany

About this study

Official title: Five-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 to Less Than 12 Months of Age With Mild to Moderate Atopic Dermatitis

Conditions: Atopic Dermatitis
Being tested: Pimecrolimus, Topical corticosteroids
Keywords: Atopic dermatitis, children, infants, pimecrolimus
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 %
Topical corticosteroidsDrug
TCS

Study groups in NCT00120523
Study group	Role	What they receive
1	Experimental	Pimecrolimus Receives: Drug: Pimecrolimus
2	Active comparator	Topical corticosteroids Receives: Drug: Topical corticosteroids

What is being measured

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

Safety Assessed by Adverse Events
crude incidence of adverse events of primary interest and most frequent adverse events (greater than or equal to 5% crude incidence in either treatment group) in the treatment period
Measured: throughout the 5-year study
Growth Velocity (Height)
Measured: throughout the 5-year study
Growth Velocity (Weight)
Measured: throughout the 5-year study
Potential Effect on the Developing Immune System
number (%) of patients with positive antibody titers to tetanus, hepatitis B, and measles vaccines at baseline, weeks 26 (6 months), 52 (1 year), 104 (2 years), 156 (3 years), 208 (4 years) and 260 (5 years) Varicella antibody titers were measured at the above time points in US patients only.
Measured: throughout the 5-year study

Secondary outcomes (5)

Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate
IGA = Investigator's global Assessment. CI = Confidence interval for treatment success using binomial distribution: lower CI<0 is set to 0, upper CI>100 is set to 100.
Treatment success (n): IGA score of 0 or 1 (clear or almost clear). Outcome gives percentage of patients with treatment success.
Measured: throughout the 5-year study
Body Surface Area Involved With Atopic Dermatitis
TBSA = Total body surface area; percent BSA affected = (BSA affected/TBSA) x 100.
Measured: throughout the 5-year study
Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD)
PIQoL-AD questionnaire (28 questions) was only done in countries where validated questionnaire was available: Germany, Hungary, Netherlands, Spain, UK and US.
For the purposes of data presentation, a "Not True" response was coded a value of zero and a "True" a value of one. The total score (i.e., sum of individual questions) was calculated; lower the score, better the QoL. Minimum score = 0; maximum score = 28. If the patient has answered ≤14 questions at a time point, then the patient's total score at the time point was set to missing.
Measured: throughout the 5-year study
Vital Signs and Physical Examinations: Blood Pressure (BP)
Significant findings are included in the relevant medical history/current medical conditions (prior to study start) or in the AE documentation (after study start.
Measured: throughout the 5-year study
Vital Signs and Physical Examinations: Pulse
Significant findings are included in the relevant medical history/current medical conditions (prior to study start) or in the AE documentation (after study start.
Measured: throughout the 5-year study

Timeline

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

Apr 2004Oct 2010

First posted18 Jul 2005 (estimated)
Study startApr 2004
Primary completionOct 2010
Study completionOct 2010

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.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 2,418 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00120523
Sponsor's protocol ID: CASM981C2306
Status last verified: Apr 2016
First submitted: 11 Jul 2005
Last updated: 11 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Sigurgeirsson B, Boznanski A, Todd G, Vertruyen A, Schuttelaar ML, Zhu X, Schauer U, Qaqundah P, Poulin Y, Kristjansson S, von Berg A, Nieto A, Boguniewicz M, Paller AS, Dakovic R, Ring J, Luger T. Safety and efficacy of pimecrolimus in atopic dermatitis: a 5-year randomized trial. Pediatrics. 2015 Apr;135(4):597-606. doi: 10.1542/peds.2014-1990. Epub 2015 Mar 23.
PubMed 25802354

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
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First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
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RecruitingPhase 3
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All Atopic Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Five-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 to Less Than 12 Months of Age With Mild to Moderate Atopic Dermatitis
ClinicalTrials.gov ID: NCT00120523
Acronym / sponsor ID: CASM981C2306
Conditions: Atopic Dermatitis
Keywords: Atopic dermatitis, children, infants, pimecrolimus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,418 participants (actual)
Lead sponsor: MEDA Pharma GmbH & Co. KGIndustry (pharma, biotech, devices)
Study start: Apr 2004
Primary completion: Oct 2010 (actual)
Study completion: Oct 2010 (actual)
First posted: 18 Jul 2005 (estimated)
Results: Posted 16 Jan 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: PimecrolimusPimecrolimus
2	Active comparator	Drug: Topical corticosteroidsTopical corticosteroids

Who may qualify

Ages: 3 to 12 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

Aged 3 to < 12 months
Diagnosis of AD fulfilling the diagnostic criteria of Seymour
AD affecting at least 5% total body surface area
Investigator's Global Assessment (IGA) score of 2 or 3, corresponding to mild-to-moderate disease at baseline
Informed consent

Key exclusion criteria (8 listed)

Phototherapy, systemic therapy (e.g., immunosuppressants, cytostatics), systemic corticosteroids within 4 weeks
Topical tacrolimus or pimecrolimus within 2 weeks
Topical therapy (e.g., tar, topical corticosteroids) within 3 days
Immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have a history of malignant disease
Active acute viral skin infection (e.g. herpes simplex, herpes zoster, chicken pox), and/or clinically infected AD

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
Topical corticosteroidsTCS	Drug	2

Primary outcome

Safety Assessed by Adverse Events
Time frame: throughout the 5-year study
crude incidence of adverse events of primary interest and most frequent adverse events (greater than or equal to 5% crude incidence in either treatment group) in the treatment period
Growth Velocity (Height)
Time frame: throughout the 5-year study
Growth Velocity (Weight)
Time frame: throughout the 5-year study
Potential Effect on the Developing Immune System
Time frame: throughout the 5-year study
number (%) of patients with positive antibody titers to tetanus, hepatitis B, and measles vaccines at baseline, weeks 26 (6 months), 52 (1 year), 104 (2 years), 156 (3 years), 208 (4 years) and 260 (5 years) Varicella antibody titers were measured at the above time points in US patients only.

5 secondary outcomes

Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate
Time frame: throughout the 5-year study
Body Surface Area Involved With Atopic Dermatitis
Time frame: throughout the 5-year study
Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD)
Time frame: throughout the 5-year study
Vital Signs and Physical Examinations: Blood Pressure (BP)
Time frame: throughout the 5-year study
Vital Signs and Physical Examinations: Pulse
Time frame: throughout the 5-year study

Results and safety

Results posted to the registry on 16 Jan 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pimecrolimus	1,205	836
Topical Corticosteroids	1,213	874

Primary outcome: Safety Assessed by Adverse Events

Time frame: throughout the 5-year study. Number. Unit: percentage of participants

Measure	Pimecrolimus n = 1205	Topical Corticosteroids n = 1213
Acute tonsillitis	8.6	7.8
Allergy to arthropod bite	5.9	4.9
Arthropod bite	7.1	8.8
Asthma	15.1	14.6
Bronchiolitis	5.4	5.7
Bronchitis	36.3	33.8
Bronchospasm	5.2	6.7
Conjunctivitis	16.5	16.2

Population analysed: complete safety/ITT population of experimental and control

Primary outcome: Growth Velocity (Height)

Time frame: throughout the 5-year study. Mean (Standard Deviation). Unit: cm

Measure	Pimecrolimus n = 1204	Topical Corticosteroids n = 1208
Baseline (n=1204, n=1208)	68.8 (5.26)	68.8 (5.14)
Week 6 (n=1144, n=1141)	71.3 (4.82)	71.3 (4.76)
Week 26 (n=1092, n=1114)	77.0 (4.37)	76.9 (4.46)
Week 52 (n=999, n=1052)	83.1 (4.23)	83.1 (4.30)
Week 104 (n=924, n=975)	93.0 (4.31)	92.9 (4.30)
Week 156 (n=871, n=919)	100.5 (4.70)	100.6 (4.72)
Week 208 (n=843, n=869)	107.7 (5.46)	107.8 (5.25)
Week 260 (n=833, n=871)	114.4 (5.26)	114.5 (5.90)

Population analysed: Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication.Patient who do not have a baseline value are excluded from the analysis.

Primary outcome: Growth Velocity (Weight)

Time frame: throughout the 5-year study. Mean (Standard Deviation). Unit: kg

Measure	Pimecrolimus n = 1203	Topical Corticosteroids n = 1213
Baseline (n=1203, n=1213)	8.2 (1.51)	8.2 (1.51)
Week 6 (n=1144, n=1144)	8.8 (1.45)	8.7 (1.41)
Week 26 (n=1093, n=1114)	10.2 (1.43)	10.1 (1.39)
Week 52 (n=1003, n=1054)	11.6 (1.52)	11.6 (1.54)
Week 104 (n=928, n=978)	14.1 (1.90)	14.1 (1.83)
Week 156 (n=873, n=924)	16.3 (2.32)	16.3 (2.29)
Week 208 (n=843, n=870)	18.6 (2.80)	18.7 (2.88)
Week 260 (n=833, n=871)	21.1 (3.51)	21.4 (3.70)

Primary outcome: Potential Effect on the Developing Immune System

Time frame: throughout the 5-year study. Number. Unit: % of patients with positive ab titer

Measure	Pimecrolimus n = 383	Topical Corticosteroids n = 391
Tetanus Baseline	81.8	85.2
Tetanus week 26	89.5	90.4
Tetanus week 52	91.9	94.0
Tetanus week 104	91.9	94.7
Tetanus week 156	93.5	92.5
Tetanus week 208	89.0	89.5
Tetanus week 260	91.1	88.9
Hepatitis B Baseline	57.5	53.6

Population analysed: Immune system function data analyses were performed on the immunology set (774 patients). Varicella titers were assessed for USA patients only (n= 104, n=108).

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected throughout the study period of 5 years.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pimecrolimus	247 of 1,205 (20.5%)	1,162 of 1,205 (96.4%)	Not reported
Topical Corticosteroids	210 of 1,213 (17.3%)	1,160 of 1,213 (95.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25802354Sigurgeirsson B, Boznanski A, Todd G, Vertruyen A, Schuttelaar ML, Zhu X, Schauer U, Qaqundah P, Poulin Y, Kristjansson S, von Berg A, Nieto A, Boguniewicz M, Paller AS, Dakovic R, Ring J, Luger T. Safety and efficacy of pimecrolimus in atopic dermatitis: a 5-year randomized trial. Pediatrics. 2015 Apr;135(4):597-606. doi: 10.1542/peds.2014-1990. Epub 2015 Mar 23.
Individual participant dataSharing planned: No

Related trials for Atopic Dermatitis

Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
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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.

The record lists no contact. Use the official record to reach the sponsor.

31 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pimecrolimus and Topical corticosteroids in people with Atopic Dermatitis, run by MEDA Pharma GmbH & Co. KG at 31 sites in 2 countries.

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 8 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 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States, Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 16 Jan 2013). 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?

Safety Assessed by Adverse Events (time frame: throughout the 5-year study). The study lists 4 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 NCT00120523, 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 11 Feb 2022.