OBJECTIVES: To identify an existing patient-reported outcome (PRO) measure to substantiate labeling or promotional claims for treatment in alopecia.  METHODS: MEDLINE®, PRO and Quality of Life Instruments (PROQOLID) and PRO and Drug Marketing Authorizations (PROLabels) databases were searched and relevant instruments were identified by reviewing abstracts, articles, and labels for concepts of interest (i.e., color/darkness, length, fullness/thickness, general appearance/attractiveness, self-esteem).  The initial instruments were further reviewed and subsequently excluded if they were: not PROs (e.g., hair coverage), not specific to scalp hair growth, or developed without patient input.  The final list of instruments was evaluated based on requirements outlined in the US Food and Drug Administration’s Final PRO Guidance for Industry (e.g., development and confirmation of conceptual framework, patient involvement in item generation, content validity, recall period, response options, consideration of patient population used for development in relation to future clinical trials).  RESULTS: Forty-five instruments were identified; 23 were patient-reported, 17 were investigator-rated, three were devices and two were objective hair measures.  Forty-one were excluded based on the criteria outlined.  The four instruments considered further included alopecia-specific items and instruments used to support the approval of drugs to stimulate hair growth (e.g., Propecia®), specifically, the Kingsley Alopecia Questionnaire (KAP), the Hair Growth Questionnaire, the Hair Problem List, and the Women’s Androgenic Alopecia Quality of Life Questionnaire (WAA-QOL).  CONCLUSIONS: None of the instruments met the PRO Guidance requirements; however, some could be adapted.  The Hair Growth Questionnaire could be revised and tested to confirm if the content of the instrument is relevant for women with alopecia as it was developed based on male input only.  Alternatively, the Hair Problem List or the WAA-QOL could be supplemented to include more concepts of interest and tested to confirm if the content of the instrument is relevant for both men and women with alopecia.