Trial · NCT00120523

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

NCT00120523, Phase 3, Completed, MEDA Pharma GmbH & Co. KG; results first posted 2013-01-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 5-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 - 12 Months of Age With Mild to Moderate Atopic Dermatitis. Trials, record NCT00120523. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00120523

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 5-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 - 12 Months of Age With Mild to Moderate Atopic Dermatitis
NCT number: NCT00120523
Status: Completed
Phases: Phase 3
Enrollment: 2,418 participants, actual
Lead sponsor: MEDA Pharma GmbH & Co. KG
Conditions: Atopic Dermatitis
Interventions: Pimecrolimus, Topical corticosteroids
First posted: 2005-07-18
Last updated: 2022-02-11
Results first posted: 2013-01-16

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Safety Assessed by Adverse Events	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
Primary	Growth Velocity (Height)	throughout the 5-year study
Primary	Growth Velocity (Weight)	throughout the 5-year study
Primary	Potential Effect on the Developing Immune System	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.
Secondary	Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate	throughout the 5-year study	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.
Secondary	Body Surface Area Involved With Atopic Dermatitis	throughout the 5-year study	TBSA = Total body surface area; percent BSA affected = (BSA affected/TBSA) x 100.
Secondary	Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD)	throughout the 5-year study	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.
Secondary	Vital Signs and Physical Examinations: Blood Pressure (BP)	throughout the 5-year study	Significant findings are included in the relevant medical history/current medical conditions (prior to study start) or in the AE documentation (after study start.
Secondary	Vital Signs and Physical Examinations: Pulse	throughout the 5-year study	Significant findings are included in the relevant medical history/current medical conditions (prior to study start) or in the AE documentation (after study start.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Safety Assessed by Adverse Events	throughout the 5-year study	complete safety/ITT population of experimental and control	percentage of participants	NUMBER
PRIMARY	Growth Velocity (Height)	throughout the 5-year study	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.	cm	MEAN
PRIMARY	Growth Velocity (Weight)	throughout the 5-year study	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.	kg	MEAN
SECONDARY	Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate	throughout the 5-year study	Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication.	percentage of participants	NUMBER
SECONDARY	Body Surface Area Involved With Atopic Dermatitis	throughout the 5-year study	Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication.	percentage of TBSA affected	MEAN
SECONDARY	Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD)	throughout the 5-year study	Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication. Patients who do not have baseline value are excluded from the analysis.	units on a scale	MEAN
SECONDARY	Vital Signs and Physical Examinations: Blood Pressure (BP)	throughout the 5-year study	Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication.Patients who do not have baseline value are excluded from analysis.	mmHg	MEAN
PRIMARY	Potential Effect on the Developing Immune System	throughout the 5-year study	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).	% of patients with positive ab titer	NUMBER
SECONDARY	Vital Signs and Physical Examinations: Pulse	throughout the 5-year study	Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication.Patients who do not have baseline value are excluded from analysis.	bpm	MEAN

Source ClinicalTrials.gov

Results by group290

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Safety Assessed by Adverse Events	Pimecrolimus	Acute tonsillitis	8.6	percentage of participants
Safety Assessed by Adverse Events	Topical Corticosteroids	Acute tonsillitis	7.8	percentage of participants
Safety Assessed by Adverse Events	Pimecrolimus	Allergy to arthropod bite	5.9	percentage of participants
Safety Assessed by Adverse Events	Topical Corticosteroids	Allergy to arthropod bite	4.9	percentage of participants
Safety Assessed by Adverse Events	Pimecrolimus	Arthropod bite	7.1	percentage of participants
Safety Assessed by Adverse Events	Topical Corticosteroids	Arthropod bite	8.8	percentage of participants
Safety Assessed by Adverse Events	Pimecrolimus	Asthma	15.1	percentage of participants
Safety Assessed by Adverse Events	Topical Corticosteroids	Asthma	14.6	percentage of participants
Safety Assessed by Adverse Events	Pimecrolimus	Bronchiolitis	5.4	percentage of participants
Safety Assessed by Adverse Events	Topical Corticosteroids	Bronchiolitis	5.7	percentage of participants

1 to 10 of 290Source ClinicalTrials.gov

See all 290 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Treatment Period	STARTED	Pimecrolimus	1,205
Treatment Period	STARTED	Topical Corticosteroids	1,213
Treatment Period	COMPLETED	Pimecrolimus	836
Treatment Period	COMPLETED	Topical Corticosteroids	874
Treatment Period	NOT COMPLETED	Pimecrolimus	369
Treatment Period	NOT COMPLETED	Topical Corticosteroids	339
Follow-Up Period	STARTED	Pimecrolimus	120
Follow-Up Period	STARTED	Topical Corticosteroids	70
Follow-Up Period	COMPLETED	Pimecrolimus	90
Follow-Up Period	COMPLETED	Topical Corticosteroids	46

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events618

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nasopharyngitis	Infections and infestations	Pimecrolimus	711	1,205
other	Nasopharyngitis	Infections and infestations	Topical Corticosteroids	715	1,213
other	Pyrexia	General disorders	Pimecrolimus	589	1,205
other	Pyrexia	General disorders	Topical Corticosteroids	605	1,213
other	Bronchitis	Infections and infestations	Pimecrolimus	438	1,205
other	Bronchitis	Infections and infestations	Topical Corticosteroids	410	1,213
other	Otitis media	Infections and infestations	Pimecrolimus	418	1,205
other	Otitis media	Infections and infestations	Topical Corticosteroids	385	1,213
other	Diarrhoea	Gastrointestinal disorders	Pimecrolimus	384	1,205
other	Diarrhoea	Gastrointestinal disorders	Topical Corticosteroids	381	1,213

1 to 10 of 618Source ClinicalTrials.gov

See all 618 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pimecrolimus
Total, all-cause mortality	Topical Corticosteroids
Total, other adverse events	Pimecrolimus	1,162	1,205
Total, other adverse events	Topical Corticosteroids	1,160	1,213
Total, serious adverse events	Pimecrolimus	247	1,205
Total, serious adverse events	Topical Corticosteroids	210	1,213

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25802354	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Pimecrolimus vs Topical Corticosteroids: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00120523

GET https://conductscience.org/api/trials/v1/NCT00120523/results?page=2

API reference For AI assistants