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 institutions and networks

Institutions

Pfizer

- DY Patil Hospital
- Father Muller Medical College Hospital
- Wizderm Specialty Skin and Hair Clinic
- Vibrance Skin Clinic
- Indushree Skin Clinic
- Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College
- Bharati Vidyapeeth (deemed to be University) Medical College Hospital & Research Centre
- KPC Medical College and Hospital
- Ayana Clinic
- B. J. Medical College & Civil Hospital
- Venkateshwar Hospital
- Dermaworld Skin Clinic
- Dr. D.Y.Patil Medical College, Hospital and Research
- Maharishi Markandeshwar Institute of Medical sciences and Research
- Indus International Hospital

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 interim report, if expected

Planned: 31/01/2026

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_NIS Protocol v3.0_Amendment 2 Clean Copy_23DEC2024_Redacted.pdf

Regulatory

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