The study to evaluate the effectiveness and safety of Elidel® in small children/babies affected by mild to moderate Atopic dermatitis (AD) in India

Completed

• Conditions: Atopic dermatitis, unspecified,

• Registration Number: CTRI/2023/02/049923
• Lead Sponsor: Mylan Pharmaceuticals Private Limited

Brief Summary

This Phase-IV, prospective, multicenter, open-label, single arm, observational study is planned to be conducted in India. Physicians participating will be those usually involved in the management of mild to moderate AD. Approximately 9-10 centers across India will be involved and a total of approximately 130 patients with mild to moderate AD (SCORAD index <50, SCORAD is a clinical tool used to assess the extent and severity of   eczema) aged at least 3 months up to a maximum of 5 years are planned to enroll in this study.

This decision to prescribe Elidel must be prior and independent from the decision include patients in the study. the patients parents and/or their legal guardians agreement to participate in the study will be obtained by  means of signing the informal consent. data to be collected during visit1 (V1)/baseline visit are information on inclusion, patients background (demography, history of AD, symptoms and previous treatments of mild to moderate AD).

The physician will record the collected and required information in an electronic case report form (eCRF). assessment of effectiveness, the intended duration of observation per patient is approximately 3 months, allowing certain flexibility as to respond to usual clinical practice. each patients is intended to follow-up to period of approximately 3 months from V1/baseline. since this is an observational study, patient visits after study entry (inclusion) should be performed as per the physicians discretion and in line with local regulations and standards of clinical practice for the management of AD patients. all the visits should be documented in the eCRF.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-24
• Last Update Posted: 2025-01-28

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• 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

• 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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessing the SCORing Atopic Dermatitis (SCORAD) index reduction in the AD areas from inclusion to the end of Elidel® treatment period.	Each Visit

Secondary Outcome Measures

Name	Time	Method
1. Treatment duration with Elidel®	2. Number of visits during Elidel® treatment period and during the maintenance phase

Trial Locations

Locations (10)

Aarvy Hospital; 🇮🇳 Gurgaon, HARYANA, India

Apollo Children Hospital; 🇮🇳 Chennai, TAMIL NADU, India

Ayana Clinic; 🇮🇳 Bangalore, KARNATAKA, India

Dr. Eswari L; 🇮🇳 Bangalore, KARNATAKA, India

Navneet Memorial Hospital "SUSHRUSHA; 🇮🇳 Ahmadabad, GUJARAT, India

S.N medical college, Agra; 🇮🇳 Agra, UTTAR PRADESH, India

Shetty’s Skin and Hair Clinic; 🇮🇳 Bangalore, KARNATAKA, India

Shree skin center; 🇮🇳 (Suburban), MAHARASHTRA, India

Silver Streak Multi Speciality Hospital; 🇮🇳 Gurgaon, HARYANA, India

Venkat Charmalaya Centre; 🇮🇳 Bangalore, KARNATAKA, India

Aarvy Hospital

🇮🇳Gurgaon, HARYANA, India

Dr Urvi Panchal

Principal investigator

8800827110

drurvi77@gmail.com