Health Condition 1: L209- Atopic dermatitis, unspecified
Conditions
Interventions
None listed
Sponsors
Mylan Pharmaceuticals Private Limited
Eligibility
Inclusion 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessing the SCORing Atopic Dermatitis (SCORAD) index reduction in the AD areas from inclusion to the end of Elidel® treatment period.Timepoint: Each Visit | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Treatment duration with Elidel® 2. Number of visits during Elidel® treatment period and during the maintenance phase 3. Reduction of symptoms based on the Visual analogue scale in the SCORAD index during Elidel® treatment period 4. Number of days and kind of AD treatments during maintenance phase 5. Number of days lost from school and/or work for patients and/or caregivers, due to AD assessed at each visit 6. Quality of life assessed by validated questionnaires at inclusion (V1), at Elidel® treatment interruption (V2) and at End of Study Visit (EoS) (V3), considering the last seven days before the assessment. Questionnaire will be selected based on patients’ age: a. The Infants’ Dermatitis Quality of Life Index (IDQOL) (below the age of 4 years) b. Children’s Dermatology Life Quality Index (CDLQI) (from the age of =4 to =5 years) 7. Elidel® safety and tolerabilityTimepoint: 1. Treatment duration with Elidel® in days from V1 to V2. 2. Number of physical as well as telephonic visits made during V1 to V2 and V2 to V3 3. Each visit 4. At the interruption visit (V2), the type of AD treatment prescribed, and number of days will be recorded up to V3 which will be at least 45 days±10 days from V2. 5. Each visit 6. (V1), at Elidel® treatment interruption (V2) and at EoS (V3), considering the last seven days before the assessment. 7. Each visit except V1 | — |
Countries
India
Contacts
Public ContactDr Rajesh Suresh Nachankar
Mylan Pharmaceuticals Private Limited
Outcome results
None listed