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Clinical Trials/CTRI/2023/02/049923
CTRI/2023/02/049923Recruiting未知

An observational study to evaluate the effectiveness and safety of Elidel® in infants and children affected by mild to moderate Atopic dermatitis (AD) in India

Mylan Pharmaceuticals Private Limited0 sites0 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
未知
Status
Recruiting
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Observational

Eligibility Criteria

Inclusion Criteria

  • •1. Signed informed consent from patients’ parent(s) or legal guardian(s) in compliance with local regulation
  • •2. Patients of Indian ethnicity
  • •3. Male and female infants and children who are at least 3 months to a maximum of 5 years of age at baseline (V1)
  • •4. Diagnosis of mild to moderate Atopic dermatitis (SCORAD index <50)
  • •5. Prescribed Elidel® 1% w/w for mild to moderate AD as part of routine clinical care and in accordance with product label prior to inclusion

Exclusion Criteria

  • •1. Patients for whom Elidel® is not recommended according to the Package Insert
  • •2. Patients with severe AD (SCORAD =50)
  • •3. Active viral infections at the treatment site
  • •4. Receiving systemic glucocorticoids, antibiotics, antifungals, immunomodulators, antihistamines and ultraviolet radiation therapy within the last 4 weeks before inclusion
  • •5. Receiving any topical AD-effective drugs within the last 2 weeks before inclusion
  • •6. Known or suspected hypersensitivity to pimecrolimus or any component of the cream
  • •7. Patients parent(s)/legal guardian (as applicable) that are not able to fulfill study requirements according to physician’s opinion
  • •8. Patients parent(s) / legal guardian (as applicable) who refuse to participate in the study

Investigators

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