The Psychological Impacts of Horizontal Frontalis Lines, Glabellar Lines, and Lateral Canthal Lines: Qualitative, Patient-Centered Studies Steven Dayan, MD1; Steven G. Yoelin, MD2; Koenraad De Boulle, MD3; Ilia L. Ferrusi, PhD4 1DeNova Research, Chicago, IL, USA; 2Medical Associates Inc., Newport Beach, CA, USA; 3Aalst Dermatology Clinic, Aalst, Belgium; 4Allergan plc, Irvine, CA, USA Scan to obtain PDF of poster INTRODUCTION • Facial lines or wrinkles are a common sign of aging, developing slowly over time due to repeated contraction of underlying facial muscles1-3 • In the upper face, 3 types of facial lines are common: lateral canthal lines (crow’s feet lines; CFL), caused by smiling or squinting; horizontal frontalis lines (forehead lines; FHL), caused by raising of the eyebrows; and glabellar lines (GL), caused by frowning1 • With age, these upper facial lines (UFL) tend to become static and visible, even when facial muscles are at rest1 • The development of UFL can influence self-perception and may have a variety of psychological impacts3-5 OBJECTIVE • To determine the psychological impact of CFL and FHL individually and of the 3 UFL areas combined • To evaluate whether the 11-item Facial Line Outcomes (FLO-11) Questionnaire3 is an adequate measure to assess CFL, FHL, and UFL psychological impacts METHODS Subjects • Two qualitative research studies (Figure 1) were conducted in adults with moderate or severe UFL (ie, CFL, FHL, and GL) at maximum contraction, as measured using the investigator-rated Facial Wrinkle Scale with photonumeric guide (FWS; 0=none; 1=mild; 2=moderate; 3=severe) • Study 1 enrolled subjects aged ≥18 years with moderate or severe CFL at maximum smile • Study 2 enrolled subjects aged 18–65 years with moderate or severe FHL at maximum eyebrow elevation only, or in conjunction with moderate or severe CFL at maximum smile, and moderate or severe GL at maximum frown • All subjects were fluent in English • Key exclusion criteria: ─ Prior periorbital surgery, facial or brow lift, or related procedure, or midfacial or periorbital treatment with permanent soft-tissue fillers, polytetrafluorethylene (Gore-Tex) implantation, or autologous fat transplantation ─ Nonablative resurfacing laser/light treatment, microdermabrasion, or superficial peels within 3 months ─ Cosmetic procedure with medium depth to deep facial chemical peels, midfacial or periorbital laser skin resurfacing, or permanent make-up within 6 months ─ Midfacial or periorbital treatment with non-permanent soft-tissue filler within the previous 12 months ─ Botulinum toxin treatment within 6 months Figure 1. Study Designs Study 1 Study 2 Concept elicitation interview: open-ended questions about psychological impacts of CFL Subjects complete the FLO-11 questionnaire Targeted questions about relevancy of FLO-11 items and FLO-11 overall for assessing psychological impacts of CFL Concept elicitation interview: open-ended questions about impacts of FHL (n=20) or UFL (n=20); subjects were also asked to define the psychological impacta Targeted questions about relevancy of FLO-11 items and FLO-11 overall for assessing psychological impacts of FHL or UFL Subjects aged ≥18 years with moderate or severe CFL at maximum contraction (n=41) Subjects aged 18–65 years with moderate or severe FHL only (n=9) or with moderate or severe UFL (CFL, FHL, and GL) at maximum contraction (n=20) aEleven subjects in addition to the 9 subjects with FHL only completed interviews about the impact of FHL. CFL, crow’s feet lines; FHL, forehead lines; GL, glabellar lines; UFL, upper facial lines. Interview Conduct • Both studies included a concept elicitation (CE) phase, followed by targeted questions about the relevancy of the FLO-11 questionnaire. All interviews were audio or video recorded, with each subject’s permission • In the CE phase, subjects were asked open-ended questions by trained interviewers about the psychological impacts of their particular facial wrinkles: CFL in study 1, and FHL or UFL combined (ie, CFL, FHL, and GL) in study 2 ─ Probing questions were asked, if necessary, to elicit concepts related to the psychological impact of their particular facial wrinkles • Following the CE phase, subjects were asked to complete the FLO-11 questionnaire and provide feedback on the relevancy of each item to the psychological impact of their particular facial wrinkles Analysis • Interview transcripts were imported into ATLAS.ti version 7.0 (Atlas.ti GmbH; Berlin, Germany) to facilitate the organization and analyses of qualitative data. Transcripts were analyzed on an ongoing basis, using a grounded theory approach to produce rich descriptions and theoretical explanations for the topic • Codes consisting of root concepts elicited from the subjects and related to the research questions were linked to relevant portions of the transcript texts. Each coded transcript was reviewed by ≥2 members of the project team until a consensus was reached • At the end of the coding process, the project team evaluated patterns in the data, with interpretation performed using a constant comparison method RESULTS Subjects • Study 1 enrolled 41 subjects with moderate or severe CFL (CFL cohort) • Study 2 included 29 subjects; 9 had moderate or severe FHL only and 20 had moderate or severe CFL, FHL, and GL (UFL cohort) ─ In the latter group, 11 subjects in addition to the 9 with FHL only completed interviews about their FHL (FHL cohort) • Study participants ranged in age from 24–72 years, and most were female and white (Table 1) Table 1. Demographics and Baseline Characteristics Characteristic Study 1 Study 2 CFL Cohort (n=41) FHL Cohort (n=20) UFL Cohort (n=20) Age, years, mean (SD) 50.7 (20.8) 44.7 (15.6) 50.4 (13.8) Age, years, range 25–69 24–72 24–72 Female, n (%) 36 (87.8) 14 (70.0) 14 (70.0) White, n (%) 34 (82.9) 17 (85.0) 17 (85.0) CFL severity at maximum smile, n (%) Moderate 28 (68.3)a — 11 (55.0) Severe 11 (26.8) — 9 (45.0) FHL severity at maximum eyebrow elevation, n (%) Moderate — 8 (40.0) 7 (35.0) Severe — 12 (60.0) 13 (65.0) GL severity at maximum frown, n (%) Moderate — — 10 (50.0) Severe — — 10 (50.0) aData shown for left side. Corresponding data for right side: 29 (70.7%) with moderate and 10 (24.4%) with severe CFL. CFL, crow’s feet lines; FHL, forehead lines; GL, glabellar lines; SD, standard deviation; UFL, upper facial lines. Concept Elicitation Phase Interview Study 1 • The most common appearance and behavioral impacts of CFL are shown in Figure 2A • The most common psychological impacts of CFL were looking older than desired, feeling depressed/sad, feeling older, and looking less attractive (Figure 2B) Figure 2. The Most Commonly Reported (≥20% of Subjects) Appearance, Emotional, and Physical Impacts (A) and Psychological Impacts (B) of Crow’s Feet Lines in Study 1 20 24 32 37 42 0 5 10 15 20 25 30 35 40 45 50 Feeling less confident Looking less attractive Feeling older Feeling depressed/sad Looking older than desired Subjects (%) CFL Cohort 37 34 44 46 73 32 51 61 63 68 83 85 85 0 10 20 30 40 50 60 70 80 90 100 Using creams PHYSICAL IMPACTS Feeling bad about appearance Feeling less attractive Feeling bothered Feeling older EMOTIONAL IMPACTS Looking older than actual age Looking stressed Looking not well rested Looking less attractive Looking tired Looking older than desired Looking older Skin appears not smooth APPEARANCE IMPACTS Subjects (%) CFL Cohort B. Interview question: Do you think your CFL have any psychological impact on yourself? If yes, how so? A. If necessary, the following probes were asked: What does psychological impact mean to you? What feelings or emotions would you consider are psychological impacts due to CFL? Would you consider any CFL impacts already discussed to be a psychological impact? Study 2 • The most common appearance and behavioral impacts of FHL and UFL are shown in Figures 3A and 3B, respectively • The most common psychological impacts of FHL were feeling bothered, feeling self-conscious, feeling older, and feeling less confident (Figure 4A) • For the UFL cohort, the most common psychological impacts were feeling bothered, feeling older, feeling less confident, and feeling less attractive (Figure 4B) Figure 3: The Most Commonly Reported (≥20% of Subjects) Appearance and Emotional Impacts of Forehead Lines (A) and Upper Facial Lines (B) in Study 2 20 25 30 35 45 20 25 30 35 35 50 50 75 85 Feeling less attractive Feeling less confident Feeling older Feeling self-conscious Feeling bothered EMOTIONAL IMPACTS Looking not well rested Looking stressed Skin appears less smooth Looking older than actual age Looking tired Looking angry Looking less attractive Looking older than desired Looking older overall APPEARANCE IMPACTS FHL Cohort Subjects (%) 0 10 20 30 40 50 60 70 80 90 100 25 30 30 40 40 20 25 30 40 50 50 65 70 0 10 20 30 40 50 60 70 80 90 100 Feeling good/bad about appearance Feeling less attractive Feeling less confident Feeling bothered Feeling older EMOTIONAL IMPACTS Looking older than actual age Looking not well rested Looking angry Looking tired Looking stressed Looking less attractive Looking older than desired Looking older overall APPEARANCE IMPACTS UFL Cohort Subjects (%) B. A. FHL, forehead lines; UFL, upper facial lines. Figure 4. The Most Commonly Reported (≥20% of Subjects) Psychological Impacts of Forehead Lines (A) and Upper Facial Lines (B) in Study 2 20 25 30 35 45 0 5 10 15 20 25 30 35 40 45 50 Feeling less attractive Feeling less confident Feeling older Feeling self-conscious Feeling bothered Subjects (%) FHL Cohort 25 30 30 40 40 0 5 10 15 20 25 30 35 40 45 50 Feeling good/bad about appearance Feeling less attractive Feeling less confident Feeling older Feeling bothered Subjects (%) UFL Cohort B. A. FHL, forehead lines; UFL, upper facial lines. FLO-11 Questionnaire • Several items of the FLO-11 questionnaire were frequently reported to be adequate measures of the psychological impact of CFL, FHL, and UFL overall. For example, Items 1, 3, and 5 elicited >68% response across all cohorts (Table 2) Table 2. FLO-11 Items Reported as Psychological Impacts of Upper Facial Lines Interview question: Do you think that this questionnaire asks you questions about the psychological impacts of CFL? If so, which questions ask you about the psychological impacts of CFL? FLO-11 Item, n (%) Study 1 Study 2 CFL Cohort (n=41) FHL Cohort (n=20) UFL Cohort (n=20) Item 1: Feeling bothered 28 (68) 16 (80) 14 (70) Item 2: Looking older than desired 29 (71) 14 (70) 11 (55) Item 3: Feeling less attractive 32 (78) 17 (85) 16 (80) Item 4: Looking older than my actual age 19 (46) 15 (75) 13 (65) Item 5: Looking less attractive 31 (76) 17 (85) 14 (70) Item 6: Looking not well rested 17 (42) 11 (55) 10 (50) Item 7: Skin appears less smooth 15 (37) 12 (60) 10 (50) Item 8: Looking tired 19 (46) 13 (65) 13 (65) Item 9: Looking stressed 22 (54) 14 (70) 14 (70) Item 10: Looking angry 20 (49) 13 (65) 11 (55) Item 11: Feeling good about appearance 23 (56) 16 (80) 14 (70) CFL, crow’s feet lines; FHL, forehead lines; UFL, upper facial lines. • The FLO-11 items most frequently reported ─ CFL cohort: Item 3 (feeling unattractive; 78.0%) and Item 2 (feeling older than desired; 70.7%) ─ FHL cohort: Item 3 (85.0%) and Item 5 (feeling less attractive than desired; 85.0%) ─ UFL cohort: Items 3 (feeling unattractive; 80.0%) and 1 (bothered by lines), 5 (looking less attractive than desired), 9 (looking stressed), and 11 (feeling good/bad about appearance) (each 70.0%) • The majority of subjects in each cohort reported that the FLO-11 questionnaire is a comprehensive measure of the psychological impacts of their particular facial lines (Figure 5) Figure 5. Subjects Reporting That the FLO-11 Questionnaire Is a Comprehensive Measure of Psychological Impacts of Crow’s Feet Lines, Forehead Lines, and Upper Facial Lines 0 10 20 30 40 50 60 70 80 90 100 CFL FHL UFL n=41 n=20 n=20 73 65 60 S ub je ct s (% ) CFL, crow’s feet lines; FHL, forehead lines; UFL, upper facial lines. CONCLUSIONS • CFL, FHL, and UFL are associated with multiple psychological impacts, including feeling older, less attractive, bothered, self-conscious, and less confident • These facial lines also affect self-perception, as subjects frequently reported looking older than their actual age, looking less attractive, and looking angry • More than 50% of subjects reported that 6 Items, 9 Items, and all 11 Items on the FLO-11 questionnaire assess the psychological impact of CFL, UFL, and FHL, respectively • The majority of subjects reported that the FLO-11 is a comprehensive measure of the psychological impacts of their particular facial lines • Based on these findings, the FLO-11 is an appropriate and comprehensive measure of the psychological impact of CFL, FHL, and UFL overall from the subject’s perspective REFERENCES 1. Finn CJ, et al. Dermatol Surg. 2003;29(5):450-5. 2. Beer K, Beer J. Facial Plast Surg. 2009;25(5):281-4. 3. Yaworsky A, et al. J Cosmet Dermatol. 2014;13(4):297-306. 4. Cox SE, Finn JC. Int Ophthalmol Clin. 2005;45(3):13-24. 5. Gupta MA, Gilchrest BA. Dermatol Clin. 2005;23(4):643-8. ACKNOWLEDGMENTS This study was sponsored by Allergan plc, Dublin, Ireland. Medical writing and editorial assistance was provided to the authors by Cactus Communications and was funded by Allergan plc. All authors met the ICMJE authorship criteria. Neither honoraria nor other form of payments were made for authorship. FINANCIAL DISCLOSURES S Dayan is an employee of DeNova Research, which received remuneration for this research from Allergan plc. SG Yoelin serves as an investigator and on a speakers’ bureau for Allergan plc. K De Boulle serves as a consultant and investigator and on a speakers’ bureau for Allergan plc. IL Ferrusi was an employee of Allergan plc at the time of this research. 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