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The Psychological Impacts of Horizontal Frontalis Lines, Glabellar Lines, and Lateral Canthal Lines: Qualitative, Patient-Centered Studies

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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
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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
Subjects (%)
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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ResearchGate has not been able to resolve any citations for this publication.
Article
Background Treatments for upper facial lines (UFL), the most visible sign of aging, are of interest to patients and clinicians alike. Patient-reported outcomes (PROs) are valuable in evaluating the impact of such treatments; however, regulatory recommendations have stipulated that the patient perspective be central in developing these assessments.Objectives(1) To evaluate the content validity of the Facial Lines Outcomes Questionnaire, a PRO instrument developed to assess upper facial line impacts, according to the regulatory guidance of the United States Food and Drug Administration and (2) assess whether it adequately measures the psychological impacts associated with crow's feet lines (CFL) (lateral canthal lines) from the patient perspective.Methods Two patient groups participated in face-to-face qualitative interviews. One group included patients with UFL (Group 1, n = 25 interviews), and the other included patients specifically with CFL (Group 2, n = 41 interviews). Each interview consisted of a concept elicitation and cognitive debriefing phase.ResultsInterviews with both groups elicited all key concepts of the instrument, including “bothered by facial lines”; “looking older”; “looking less attractive”; and looking “tired,” “stressed,” or “angry.” Most Group 2 patients (n = 35, 85%) agreed that the instrument adequately assessed the psychological impacts associated with CFL. During cognitive debriefing, the majority of patients in both groups agreed the instrument was understandable, comprehensive, and easy to complete.Conclusions The Facial Line Outcomes Questionnaire is an appropriate and valid tool to assess the impact of UFL and the psychological impacts associated with CFL.
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Many older individuals use products and procedures to conceal or delay the signs of aging. For most, this provides a helpful ego boost, but some suffer from pathologies such as eating disorders and body dysmorphic disorder. The impact of aging skin may include social anxiety and social isolation. Poor self-image is associated with chronic illness and fewer preventive health behaviors, such as exercise. Aged appearance, especially in women, is also associated with workplace discrimination. Patients should therefore be offered treatments for aging skin, ensured that society's negative views not be unnecessarily reinforced, and maintain a realistic treatment expectations.
  • C J Finn
Finn CJ, et al. Dermatol Surg. 2003;29(5):450-5.
  • K Beer
  • J Beer
Beer K, Beer J. Facial Plast Surg. 2009;25(5):281-4.
  • S E Cox
  • J C Finn
Cox SE, Finn JC. Int Ophthalmol Clin. 2005;45(3):13-24.