An Immuno-Dermatological disease registry to understand the burden of Atopic dermatitis (AD), Alopecia areata (AA), and Vitiligo in Indian Patients

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/106116
• EU PAS number:
  EUPAS48566
• Study ID:
  106116
• Official title and acronym:
  An Immuno-Dermatological disease registry to understand the burden of Atopic dermatitis (AD), Alopecia areata (AA), and Vitiligo in Indian Patients
• DARWIN EU® study:
  No
• Study countries:
  India
• Study description:
  A prospective observational multi-center study in India to evaluate the epidemiological burden of mild, moderate and severe atopic dermatitis, vitiligo and alopecia areata.
• Study status:
  Ongoing

Research institution and networks

Institutions

Pfizer

- Father Muller College Mangalore
- Calcutta National Medical College Kolkata
- LTMC Sion Mumbai, DY Patil Hospital
- Mumbai Navi Mumbai
- Amrita Institute of medical sciences
- Kerala Kochi
- MMFHA Joshi Hospital Pune
- Dr. Madhavi's advanced skin hair and laser clinic
- Balkampet Hyderabad Hyderabad
- Indushree Skin Clinic Lucknow Lucknow
- Basanavagudi Clinic Pune
- Paras Hospital Gurgaon Bangalore

Networks

Insignia

Study timelines

Date when funding contract was signed

Planned: 02/05/2022

Actual: 28/06/2022

Study start date

Planned: 29/09/2023

Actual: 28/08/2023

Date of final study report

Planned: 30/12/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

B7451103 Non-Interventional Study Protocol Version 1.0_ 30 September 2022_Redacted

Updated protocol

B7451103 Non Interventional Study Amendment 1_ Version 2.0 (clean) 19Apr23_Redacted

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable