Observational Study to Evaluate the Actual Use of Elidel® in Chinese Patients With Mild to Moderate Atopic Dermatitis

Mylan

Status: Completed

Conditions: Atopic Dermatitis

Treatments: Drug: Pimecrolimus 1% Top Cream

Study type: Observational

Funder types: Industry

Identifiers

NCT04976868

3328

Details and patient eligibility

About

The primary objective of the present multicentre, prospective, non-interventional study (NIS) is gathering knowledge on the actual use and effectiveness of Elidel® in Chinese patients with mild to moderate AD affecting sensitive skin areas in routine clinical practice.

Enrollment: 130 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients of Chinese ethnicity

• Patients at least 2 years old

• Signed informed consent from patient and if applicable from parent(s) or legal guardian(s) in compliance with local requirements

• Patients with mild to moderate AD and depending on the age:

• Patients 2-12 years must have:

  • SCORAD Index < 50

• Patients 13 years and older must have:

  • Affecting sensitive skin areas (e.g. face, intertriginous sites, anogenital area)
  • SCORAD Index < 50 and IGA in sensitive skin areas ≤ 3

Exclusion criteria

• Patients for whom Elidel® is not recommended accordingly to the Package Insert
• Patients with severe atopic dermatitis (SCORAD Index ≥ 50 or IGA in sensitive skin > 3)
• Receiving systemic glucocorticoids, antibiotics, antifungals, immunomodulators, inhibitors, antihistamines and ultraviolet radiation therapy within the last 4 weeks before inclusion;
• Receiving any topical AD-effective drugs within the last 2 weeks before inclusion;
• Pregnant and/or breastfeeding women
• Patients or parent(s) / legal guardian (as applicable) that are not able to fulfil study requirements according to physician's opinion
• Patients or parent(s) / legal guardian (as applicable) that refuse to participate to the study

Trial design

130 participants in 1 patient group

Pimecrolimus Cream 1% - Elidel®

Description:

Elidel® as prescribed within routine clinical practice

Treatment:

Drug: Pimecrolimus 1% Top Cream