Safety and Efficacy of Pimecrolimus Cream 1% in Atopic Disease Modification
Public ClinicalTrials.gov record NCT00124709. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT00124709
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 1,091 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 3 Months to 18 Months
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 2003 (Type not available)
- Primary completion
- Jan 2008 (Actual)
- Completion
- Nov 2008 (Actual)
- Last update posted
- Mar 23, 2011
2003 – 2008
United States locations
- U.S. sites
- 36
- U.S. states
- 24
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Allergy and Asthma Center | Birmingham | Alabama | 35209 | — |
| Northwest Arkansas Pediatric Clinic, P.A. | Fayetteville | Arkansas | 72703 | — |
| The Children's Clinic of Jonesboro | Jonesboro | Arkansas | 72401 | — |
| Southern California Research | Mission Viejo | California | 92691 | — |
| Children's Hospital of Orange County | Orange | California | 92868 | — |
| Stanford Dermatology Clinic and Clinical Trials Dept | Redwood City | California | 94063 | — |
| Capital Allergy Respiratory Disease Center | Sacramento | California | 95819 | — |
| Children's Hospital San Diego | San Diego | California | 92123 | — |
| Allergy and Asthma Medical Group of Diablo Valley, Inc./ Clinical Research Division | Walnut Creek | California | 94598 | — |
| National Jewish Medical and Research Center | Denver | Colorado | 80206 | — |
| Dermatology Associates and Research | Coral Gables | Florida | 33134 | — |
| Emerald Coast Clinical Research | Pensacola | Florida | 32503 | — |
| Children's Memorial Hospital | Chicago | Illinois | 60614 | — |
| Indiana University Outpatient Clinical Research | Indianapolis | Indiana | 46202 | — |
| Central Kentucky Research Associates | Lexington | Kentucky | 40509 | — |
| Dermatology Specialists | Louisville | Kentucky | 40202 | — |
| Rx R & D | Metarie | Louisiana | 70002 | — |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | — |
| Children's Hospital - Boston | Boston | Massachusetts | 02115 | — |
| Dermatology, PLLC | Ann Arbor | Michigan | 48103 | — |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | — |
| Central Dermatology | St Louis | Missouri | 63117 | — |
| Skin Specialists, P.C. | Omaha | Nebraska | 68144 | — |
| Dartmouth-Hitchcock Medical Center/Dermatology Section | Lebanon | New Hampshire | 03756 | — |
| Children's Medical Group | Hopewell Junction | New York | 12533 | — |
| Dermatology Associates of St. Luke's - Roosevelt | New York | New York | 10025 | — |
| Calcagno Research and Development | Gresham | Oregon | 97030 | — |
| Oregon Health Science University - Dermatology Dept. | Portland | Oregon | 97201 | — |
| The Childrens' Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | — |
| Texas Children's Hospital, BCM | Houston | Texas | 77030 | — |
| Alpine Medical Group, LLC | Salt Lake City | Utah | 84102 | — |
| Granger Medical Clinic | West Valley City | Utah | 84120 | — |
| Virginia Clinical Research | Norfolk | Virginia | 23507 | — |
| Asthma Inc | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00124709, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 23, 2011 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00124709 live on ClinicalTrials.gov.