10 Year Registry of Children (Ages 2-17 Years) With Eczema That Have Used Pimecrolimus (PEER)
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ClinicalTrials.gov Identifier: NCT00568997 |
Recruitment Status :
Recruiting
First Posted : December 6, 2007
Last Update Posted : December 15, 2021
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Condition or disease | Intervention/treatment |
---|---|
Atopic Dermatitis | Drug: Pimecrolimus |
Study Type : | Observational |
Estimated Enrollment : | 8000 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | A Prospective 10 Year Observational Registry of Pediatric Subjects (Age Greater Than or Equal to Two Years to Age Less Than or Equal to 17 Years) With Atopic Dermatitis Who Have Used Elidel Cream 1% (Pimecrolimus) |
Actual Study Start Date : | June 27, 2005 |
Estimated Primary Completion Date : | December 2026 |
Estimated Study Completion Date : | December 2026 |

Group/Cohort | Intervention/treatment |
---|---|
1
Single-group Open Label Registry of patients exposed to Elidel/Pimecrolimus
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Drug: Pimecrolimus
Pimecrolimus 1% cream
Other Name: Elidel |
- The incidence rate of systemic malignancies in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream [ Time Frame: 10 years of observation with 6-month reporting intervals ]
- The incidence rate of lymphoma in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream [ Time Frame: 10 years of observation with 6-month reporting intervals ]
- The incidence rate of thyroid cancer in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream [ Time Frame: 10 years of observation with 6-month reporting intervals ]
- The incidence rate of cutaneous malignancy in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream [ Time Frame: 10 years of observation with 6-month reporting intervals ]

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Ages Eligible for Study: | 2 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- males and females
- greater than or equal to 2 years and less than or equal to 17 years at enrollment
- diagnosis of atopic dermatitis (confirmed by treating physician)
- applied pimecrolimus cream 1 % 6 weeks out of past 24 weeks
Exclusion Criteria:
- past or present history of systemic malignancy, skin malignancy, or lymphoproliferative disease
- past or present use of oral immunosuppressive therapy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00568997
Contact: Sandra Narain | 908-242-8287 | sandra.narain@bauschhealth.com |
United States, Pennsylvania | |
Registry | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: NA NA |
Study Director: | Anya Loncaric | Bausch Health |
Responsible Party: | Bausch Health Americas, Inc. |
ClinicalTrials.gov Identifier: | NCT00568997 |
Other Study ID Numbers: |
CASM981C2311 |
First Posted: | December 6, 2007 Key Record Dates |
Last Update Posted: | December 15, 2021 |
Last Verified: | December 2021 |
Atopic dermatitis eczema pediatric pimecrolimus malignancy |
Dermatitis, Atopic Dermatitis Eczema Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Pimecrolimus Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Dermatologic Agents Immunosuppressive Agents Immunologic Factors Calcineurin Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |