ABSTRACT
Background: Currently available patient-reported outcome measures (PROM) have limited ability to assess unique issues related to lateral canthal lines (LCL). This study aimed to develop a PROM to assess the severity and psychosocial impact of LCL in afflicted patients. Methods: We conducted a cross-sectional survey at a tertiary hospital and two local clinics in Korea. Exploratory factor analysis was conducted to identify the underlying factor structure of the Facial Line Distress Scale for LCL (FINE-LCL), and the internal consistency and test-retest reliability were also examined. Results: We developed a questionnaire comprising 20 items in four domains. Coefficient alphas ranged from 0.94 to 0.97 for subdomains and 0.97 for the total questionnaire. The test-retest intraclass correlation coefficient ranged from 0.77 to 0.90. The FINE-LCL was moderately correlated with the appearance appraisal score and body image. Analysis of the accuracy of the FINE-LCL score in predicting severe LCL was characterized by an area under the curve of 0.79. Conclusions: FINE-LCL is a reliable, valid, and comprehensive PROM for the assessment of the severity of LCL and their associated distress.
ABSTRACT
BACKGROUND: Forehead lines (FL) are one of the main signs of aging. Traditional tools to measure FL have limited ability to evaluate the multidimensional impact of these lines on appearance, confidence, and psychological and social relationships. OBJECTIVES: We developed and validated the Facial Line Distress Scale-Forehead Lines (FINE-FL) to evaluate the severity and psychosocial distress associated with FL. METHODS: We conducted a cross-sectional survey for FINE-FL psychometric validation at a tertiary hospital and 2 local clinics in Korea. First, a preliminary item pool for the FINE-FL was developed through a qualitative interview based on literature reviews and expert consultations. Second, cognitive interviews and a pilot test were conducted to evaluate comprehension, ease of response, acceptability of terminology, phrasing, and response options. FINE-FL consisted of 26 items. In this study, exploratory factor analysis was conducted to identify the underlying factor structure of the FINE-FL, and internal consistency and test-retest reliability were also examined. RESULTS: We found 21 items in 4 domains. The model fit was good. Coefficient αs ranged from 0.89 to 0.95 for subdomains and 0.96 for the total. The FINE-FL was moderately correlated with the appearance appraisal score. On the test-retest, the range of the intraclass correlation coefficient was 0.65 to 0.79. CONCLUSIONS: FINE-FL is a reliable, valid, and comprehensive patient-reported outcome measure for assessing FL severity and distress. This will be helpful in determining a patient's eligibility for inclusion in a study and measuring primary or secondary effectiveness endpoints for forehead line treatment.
Subject(s)
Forehead , Humans , Reproducibility of Results , Cross-Sectional Studies , Surveys and Questionnaires , Psychometrics/methodsABSTRACT
This study aimed to explore pharmacokinetics, pharmacodynamics, and safety/tolerability of MT921, an injectable cholic acid, after a single subcutaneous administration to healthy volunteers. A randomized, double-blinded, placebo-controlled, single dose-ascending phase 1 study enrolled 24 subjects who were assigned to three groups (60 mg, 120 mg, and 150 mg) of MT921. Blood samples were obtained for a 24-h period before and after injecting MT921 to the submental fat area. Plasma concentrations of cholic acid and deoxycholic acid were determined for pharmacokinetic analysis. Levels of free fatty acid, triglyceride, and total cholesterol were measured for pharmacodynamic analysis. Safety and tolerability were assessed until 21 days post-dose. While systemic exposure to cholic acid tended to increase as the MT921 dose increased, pharmacokinetic profiles of deoxycholic acid were similar among dose groups without showing significant changes. Pharmacodynamic profiles were comparable when measured at baseline and post-dose. The most frequent adverse events were injection site pain and edema. All adverse drug reactions resolved without treatment. MT921 appeared to be well-tolerated after an injection to the submental area at a dose up to 150 mg. Systemic exposure to cholic acid increased as the dose increased. Blood lipid profiles and deoxycholic acid levels were not affected by MT921 treatment.
