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

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Drug Evaluation (ODE) III
Division of Dermatology and Dental Products (DDDP)

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

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