OBJECTIVES Psoriasis is a chronic inflammatory skin condition that affects an estimated 4.5 to 7.5 million people in the United States.  Numerous clinical trials have been conducted in psoriasis, many of which have included general dermatologic or psoriasis-specific PROs as study outcome measures.  Commonly used PROs in these trials include the Dermatology Life Quality Index (DLQI), Psoriasis Disability Index (PDI), Psoriasis Life Stress Inventory (PLSI), Psoriasis Quality of Life Questionnaire (PQOL-12), and Skindex. This study assessed how well the development and validation process of psoriasis-specific PROs align with the FDA PRO guidance. METHODS We reviewed the development and validation studies of the five PROs to assess if they align with the FDA PRO guidance criteria with regard to: (1) content validity, including patient input in concept elicitation, item generation, and cognitive debriefing; and (2) psychometric testing, including construct validity, internal-consistency and test-retest reliability, and responsiveness. RESULTS The PDI was developed without patient input in terms of concept elicitation, item generation, or cognitive debriefing.  Variability and oftentimes inadequately documented evidence of patient input for concept elicitation, item generation, and cognitive debriefing were observed for the other four PROs.  Test-retest reliability was not evaluated in the PLSI.  Evidence of responsiveness was not available for three of the PROs.     CONCLUSIONS Based on this review, additional qualitative and quantitative research is needed to eliminate the identified gaps before these PROs could fulfill the FDA guidance for inclusion as a measure for a PRO label claim.