OBJECTIVES: Platysma prominence (PP) appears as aesthetically undesirable vertical neck bands with blunting of the jawline. This research, conducted per FDA patient-reported outcomes (PRO) Guidance for the Industry, aimed to develop and validate novel PROs, including Participant Allergan PP Scale (P-APPS), Bother Assessment Scale-PP (BAS-PP), Appearance of Neck and Lower Face Questionnaire (ANLFQ): Impacts, and ANLFQ: Satisfaction (Baseline/Follow-up).

METHODS: Three rounds of participant interviews were conducted to develop PROs that assess PP severity (P-APPS), bother (BAS-PP), psychosocial impact (ANLFQ: Impacts), and satisfaction (ANLFQ: Satisfaction). Mixed concept elicitation and cognitive debriefing (CD) interviews (round 1; N=30) aimed to understand individuals’ experiences with PP and support P-APPS adaptation from an existing clinician-rated scale. CD interviews (round 2; N=20) evaluated relevance and interpretability of the P-APPS and ANLFQs; subsequent interviews (round 3; N=5) tested the BAS-PP. Psychometric properties were evaluated for each measure, where applicable, using phase 2 trial data (ie, response distributions, factor analysis, inter-rater reliability, internal consistency, test-retest reliability, convergent validity, known-groups, and distribution- and anchor-based estimates for meaningful change).

RESULTS: Round 1 elicited participant-friendly terminology for the P-APPS and confirmed that individuals are bothered and negatively impacted by PP and seek treatment. Participants frequently reported looking older than desired (93%), feeling self-conscious (80%), feeling less attractive (67%), and looking less attractive (63%) due to PP. Most (97%) reported being bothered by ≥1 aspect of PP. Rounds 2 and 3 confirmed the PROs’ content validity. Psychometric results for nearly all analyses across all measures met accepted performance criteria (eg, ICC[2,k] for clinician-rated severity, Cronbach’s α for internal consistency, Spearman correlations for convergent validity), supporting the validity and reliability properties of the measures.

CONCLUSIONS: These new measures assessing severity and impact of PP exhibited adequate content and psychometric validity and can be used in future studies to assess burden of condition and its improvement with treatment.