DDT COA #000101: Patient-Reported Symptoms and Impacts of Alopecia Areata

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Immunology and Inflammation (OII)
Division of Dermatology and Dentistry (DDD)

DDT COA Number
DDT COA #000101

Instrument Name
Patient-Reported Symptoms and Impacts of Alopecia Areata

Disease/Condition
Alopecia areata (AA)

Concept of Interest
Concepts related to hair loss and regrowth deemed important by patients with AA

Context of Use
Adult patients (> 18 years) with AA with at least > 25% hair loss on scalp and current episode of hair loss lasting at least 6 months

COA Type
PRO

Qualification Stage
Letter of Intent - Accepted

Requestor(s)
National Alopecia Areata Foundation

Contact(s)
Dory Kranz

Date Accepted into CDER’s COA Qualification Program
March 9, 2018

Submission and Regulatory Correspondence History

Qualification Submission	Date	FDA Submission Decision & Recommendations	Date
Letter of Intent	10/17/17	FDA Response (Accepted)	3/8/18