Elidel 1% Topical Cream
DrugElidel® 1% is a non-steroid cream for cutaneous use containing pimecrolimus. It is indicated for mild or moderate AD.
NCT Number: NCT06052995
Elidel® is indicated for the short-term treatment and long-term management of signs and symptoms of atopic dermatitis (AD) in infants (3 to 23 months), children (2 to 11 years), adolescents (12 to 17 years), and adults. However, little evidence is available in literature in South and East Asian population. Hence, this non interventional study (NIS) is designed to capture data about the actual use of Elidel® in South and East Asian patients from 3 months to 12 years with mild to moderate AD.
This study is active but is not currently recruiting participants.
Notify Me3 month–12 year
All sexes
Observational
Viatris Clinical Site, Kuala Lumpur, Malaysia
Once the clinical decision has been made to prescribe Elidel® to a patient according to the local Package Insert, the investigator will consider recruiting the patient into this NIS. The decision to prescribe Elidel® must be prior to and independent from the decision to include the patient into the NIS.
As per study design:
End of Study will be approximately 6 months after the inclusion depending on length of the Elidel® Treatment Period. Collection of data includes but not limited to patients' demographics, clinical history, clinical symptom and manifestation, comorbidities, reported adverse events and concomitant medications. The patients' questionnaires (IDQOL and CDLQI) will be utilized to collect data directly from enrolled patients and transferred into the CRF.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients must meet all of the following inclusion criteria to be eligible for enrolment into the study:
Malaysia: Patients > 2 years and <12 years old. Hong Kong: Patients >3 months and <12 years old. Thailand: Patients >3 months and <12 years old. Taiwan: Patients >3 months and <12 years old.
Exclusion criteria
Patient candidates must not be enrolled in the study if they meet any of the following criteria:
Elidel® 1% is a non-steroid cream for cutaneous use containing pimecrolimus. It is indicated for mild or moderate AD.
Time frame: 6 months
Time frame: 6 months
Treatment duration with Elidel®
Time frame: 6 months
Time frame: 6 months
Number of days lost from school and/or work for patients and/or caregivers, assessed at each visit.
Time frame: 6 months
Elidel® safety and tolerability (adverse drug reactions [ADRs] and special situations [SpS]) during the whole study period.
BGP Products Operations GmbH, a Viatris company
Industry
Observational Study to Evaluate the Actual Use of Elidel® in South and East Asian Patients From 3 Months to 12 Years With Mild to Moderate Atopic Dermatitis.
Acronym: Elidel-SEA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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