A Validated Lip Fullness Grading Scale

ALASTAIR CARRUTHERS, MD, JEAN CARRUTHERS, MD,y BHUSHAN HARDAS, MD,z

MANDEEP KAUR MD, MS,z ROMAN GOERTELMEYER, PHD,z DEREK JONES, MD,y
BERTHOLD RZANY, MD, PHD,z JOEL COHEN, MD,J MARTINA KERSCHER, MD, PHD,#
TIMOTHY CORCORAN FLYNN, MD, COREY MAAS, MD,yy GERHARD SATTLER, MD,zz
ALEXANDER GEBAUER, MD,z RAINER POOTH, MD,z KATHLEEN MCCLURE, RN,z
ULLI SIMONE-KORBEL,z AND LARRY BUCHNERyy

OBJECTIVES To develop the Lip Fullness Grading Scale for objective quantification of lip volume for a reliable
assessment and to establish the reliability of this photonumeric scale for clinical research and practice.
MATERIALS AND METHODS A 5-point photonumeric rating scale was developed to objectively quantify
fullness of upper and lower lip separately. Nine experts rated photographs of 35 subjects, twice, sep-
arately for upper and lower lip. Inter- and intrarater variability was assessed by computing intraclass
correlation coefficients.
RESULTS Agreement between the experts was high. Bubble plots (bivariate scatter plots) demon-
strated linearity in judgment by the experts.
CONCLUSION The 5-point photonumeric scale generated spans the fullness of the upper and lower lip for
which patients commonly seek correction. This scale is well stratified, with low intra- and interrater variability.
Drs. Alastair Carruthers, Jean Carruthers, Derek Jones, Berthold Rzany, Joel Cohen, Martina Kerscher,
Timothy Corcoran Flynn, Corey Maas, and Gerhard Sattler are paid consultants to Merz Pharmaceuticals.
Dr. Bhushan Hardas, Dr. Mandeep Kaur, Dr. Roman Goertelmeyer, Dr. Alexander Gebauer, Dr. Rainer Pooth,
Kathleen McClure, and Ulli Simone-Korbel are employees of Merz Pharmaceuticals. Larry Buchner is an
employee of Canfield Scientific.

L ip augmentation, sometimes called augmenta-

tion cheiloplasty, is the use of a surgical or
injection procedure to improve lip fullness and
definition. Patients who request lip augmentation
tend to fall into one of three groups. There are
patients with good lip shape who want more fullness;
patients who want to enhance atrophic lips caused by
aging or genetics; and patients who have poor
definition of the vermilion border, often associated with
advancing age or a history of cigarette smoking.1
The first injectable filling agent approved by the
Food and Drug Administration (FDA), bovine col-
lagen, was approved in 1981 and remains the most
commonly used product for skin and soft-tissue
augmentation.2 Used first to minimize wrinkles in
the perioral area, the shift to using collagen for
augmenting lip volume began a few years later. Since
then, lip augmentation has become an application of
tissue augmentation.3 Injectable dermal fillers com-
monly used today include autologous transfers of fat

Department of Dermatology and Skin Sciences, University of British Columbia, Vancouver, British Columbia, Canada;
y
Department of Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, British Columbia,
Canada; zResearch and Development, Merz Pharmaceuticals, Greensboro, North Carolina; yDepartment of
Dermatology, University of California at Los Angeles, California; zCharitéFUniversitätsmedizin Berlin, Klinik für
Dermatologie, Division of Evidence Based Medicine (dEBM), Berlin, Germany; JAboutSkin Dermatology and
DermSurgery, Englewood, and Department of Dermatology, University of Colorado, Denver, Colorado; #Division of
Cosmetic Sciences University of Hamburg, Germany; Department of Dermatology, University of North Carolina at
Chapel Hill, and Cary Skin Center, Cary, North Carolina; yyDivision of Facial Plastic and Reconstructive Surgery,
University of California at San Francisco, California; zzRosenparkklinik GmbH, Darmstadt, Germany; yyCanfield
Scientific, Fairfield, NJ

& 2008 by the American Society for Dermatologic Surgery, Inc.
Published by Wiley Periodicals, Inc.

ISSN: 1076-0512
Dermatol Surg 2008;34:S161–S166
DOI: 10.1111/j.1524-4725.2008.34365.x

S161
 VA L I D AT E D L I P F U L L N E S S G R A D I N G S C A L E
or collagen and injections of allogeneic or synthetic
collagen or hyaluronic acid.4
The objective of lip augmentation is a natural,
three-dimensional enhancement of lip volume with
well-defined vermilion borders.5 Rebalancing fat
distribution with autologous or nonautologous
fillers restores the harmonious aesthetic of the face.6
Although most dermatologic journal articles on lip
augmentation focus on treatment options, there is
little discussion outside of dental journals about the
relative dimensions that constitute the shape of an
ideal lip. Similarly, there does not appear to be a
rating scale for evaluating lip augmentation. A
MEDLINE search using the non-Medical Subject
Heading terms validated rating scale and senescent
lips, atrophic lips, augmentation cheiloplasty, or lip
augmentation did not show a record of any validated
rating scales.
There is a need for a rating scale for lip augmentation
that could establish guidelines in the clinical setting
and provide a standard, objective evaluation of
clinical trial outcomes. In this article, we present the
Lip Fullness Grading Scale for precise, three-dimen-
sional measurement of lip volume and the clinimetric
evaluation that establishes the validity, reliability,
and responsiveness of this photonumeric scale.
Methods
A clinician was involved in the development of
morphing methodology and the description of the
scales. Approximately 50 images (per scale valida-
tion set) were selected from the photographic
database of 100 subjects based on quality and
equal distribution across each representative scale.
Using a standardized php-based computer random-
ization program, 35 images per target area or
validation set were randomly selected from the 50
for final inclusion in the pool. Practice booklets were
distributed to each of the evaluators for practice
grading using the newly designed visual assessment
rating scales as a reference. The quality assurance
representative acted as a proctor. The proctor
S162 D E R M AT O L O G I C S U R G E RY
monitored the exercise and confirmed that each
evaluator filled out the supplied practice booklet
correctly. Once all practice booklets were completed,
the good clinical practice (GCP) auditor checked
independently that the booklets included the eva-
luator’s full name, signature, initials, and date of
signature and verified that every image was ade-
quately scored.
The same process was used for the first evaluation
booklets. Once the GCP auditor had checked all
practice and evaluation booklets for completeness,
they were provided to two members of the team for
score tabulation in summary spreadsheets.
Assessment Scale
The Lip Fullness Grading Scale (Figure 1A) is a
5-point photonumeric rating scale that was developed
to objectively quantify the 3-dimensional fullness of
the lip. The scale ratings are 0 for very thin, 1 for thin,
2 for moderately thick, 3 for thick, and 4 for full.
Validation of Assessment Scale by Experts
A total of nine experts in the field of aesthetic
medicine rated 35 cases presented as photographs of
real persons (Figure 1B). During the training session,
the experts made the proposal to evaluate the upper
and lower lips separately using the morphed scale
that shows both parts of the lips.
After an initial training session and a discussion of the
practice cases, each expert performed independent
assessments of the 35 cases on 2 consecutive days.
The data were double entered into a database and
checked for correctness.
Statistical Analyses
Descriptive statistics (standard deviation, mean,
median, maximum, and minimum) were calculated
for the ratings per day (Tables 1 and 2). The stability
of ratings is visualized as bivariate scatter plots
(bubble plots). A bubble plot is a way of representing
 CARRUTHERS ET AL

Figure 1. Lip Fullness Grading Scale: (A) morphed images, (B) untouched validation images.

the relationship between variables on a scatter plot.
Observations on two variables are plotted in the
usual way, using circles as symbols; the radii of the
circles are made proportional to the associated val-
ues for the third variable. The frequency of the given
scores determines the size of the bubbles, which are
ideally located along the diagonal.
Histograms (Figures 2 and 3) show the frequency of
ratings for each view and time point.

34:S2:NOVEMBER 2008 S163

 VA L I D AT E D L I P F U L L N E S S G R A D I N G S C A L E

TABLE 1. Descriptive Statistics for Lower Lip TABLE 2. Descriptive Statistics for Upper Lip
Fullness Fullness

Day 1 2 Day 1 2

Mean 1.74 1.71 Mean 1.22 1.22

Median 2 2 Median 1 1
STD 1.10 1.09 STD 1.10 1.19
Min 0 0 Min 0 0
Max 4 4 Max 4 4

Validity and Reliability
For each aspect and time point, intraclass correlation
coefficients (ICCs) were calculated according to the
model of random selection of cases and raters.7,8 The
appropriate ICC under these assumptions will be the
Shrout-Fleiss random set reliability coefficient, which is
used when the same raters rate all cases and the raters
are regarded to be a random set of all possible raters
(0–0.3 is poor, 0.4–0.6 is moderate,  0.7 is high).
The Pearson correlation coefficient was calculated
as a test–retest reliability estimator for stability of
rating per expert after an overnight interval over all
cases for each rater.
Results
The evaluators present during the meeting fully
completed, signed, initialed, and dated all practice
and evaluation booklets. The results from the training
session are not included in the evaluation. ICCs were
calculated for upper (first rating 0.762, second rating
0.690) and lower lip (first rating 0.765, second rating
0.755) fullness based on 35 cases rated by nine ex-

130
110
120
100
110

90 100

80 90

80
FREQUENCY

70
FREQUENCY

70
60
60
50
50
40 40

30 30 Time 1
Time 1 Mean: 1.22
Mean: 1.74 Median: 1
20 Median: 2 20 STD: 1.10
STD: 1.10
10 Time 2
10 Time 2 Mean: 1.22
Mean: 1.71 Median: 1
Median: 2 0 STD: 1.19
STD: 1.09
0
0 1 2 3 4 0 1 2 3 4 RATING 0 1 2 3 4 0 1 2 3 4 RATING
1 2 TIME 1 2 TIME

RATING 0 1 2 3 4 RATING 0 1 2 3 4

Figure 2. Histogram of lower lip fullness. Figure 3. Histogram of upper lip fullness.

S164 D E R M AT O L O G I C S U R G E RY

Figure 4. Bubble plots of all experts for upper lip fullness.
perts. As can be seen from the ICCs, the agreement
between the experts was moderately strong. Further-
more the test–retest correlation coefficients (upper lip
fullness: minimal 0.716, maximal 0.971; lower lip
fullness: minimal 0.779, maximal 0.972) were high
for each judge after an overnight interval.
Bubble plots for each expert and view are given in
Figures 4 and 5 for comparing the bivariate fre-
quencies of scores between the experts. The size of
the bubbles indicates the observed frequency of the
given scores. As can be seen from Figures 4 and 5, it
appears that, especially for the view of upper lip
fullness, the majority of cases presented were of low
intensity, indicated by the bubbles on the lower ranks
of the scales. Nevertheless, in both views, a good
intra-individual correlation was observed.
In Figures 2 and 3 histograms are given showing
the frequency of ratings for each view and day. At
both time points per view, the mean and median are
almost identical, and a similar distribution can be
CARRUTHERS ET AL
observed. Comparing the distributions of both
views, it became obvious that separating upper and
lower lip ratings was necessary, because the distri-
butions were not similar.
Discussion
Cosmetic lip augmentation consists of the enlarge-
ment and reshaping of otherwise normal upper or
lower lips to improve their three-dimensional rela-
tionship with the patient’s nose, teeth, and sur-
rounding facial structures and by their function
during animation and speech.
The results from this exercise in aesthetic medicine
comparing real-life photographs with morphed im-
ages associated with a 5-point scale resulted in
moderately high ICCs. The statistical model used for
these estimates assumes a random subset of raters
from a population of experts in the aesthetic med-
icine field. The coefficients can therefore be regarded
as conservative estimates on interrater reliability.
34:S2:NOVEMBER 2008 S165
 VA L I D AT E D L I P F U L L N E S S G R A D I N G S C A L E
Figure 5. Bubble plots of all experts for lower lip fullness.
Test–retest reliability coefficients indicated suffi-
ciently high stability of the ratings after an overnight
interval. The expert raters used the morphed images
to judge photographs of live patients. Morphed im-
ages, although standardized to a site-specific area, do
not translate clinically to the multiple physical
changes that occur in an aging face. The photo-
graphic evaluation and live patient evaluation are
distinct, and thus should a clinical trial use this val-
idated scale, the evaluations in the clinical trial
should be performed on standardized photographs,
not (live) physical examination.
Conclusions
Comparing the distributions of both views, it
became obvious that separating upper and lower
lip rating was necessary, because the distributions
in the histograms of Figures 2 and 3 were not
similar. The upper and lower lip fullness was
differently rated in many cases. Furthermore, it
should be tested whether the scales can be applied
to other ethnic groups because of different lip shapes.
S166 D E R M AT O L O G I C S U R G E RY
References
1. Beer KR. Rejuvenation of the lip with injectables [on-line].
Available at: http://www.skintherapyletter.com/2007/12.3/2.html
Accessed July 5, 2008.
2. Gampper TJ, Tholpady A, Monheit GD, Kayal JD. Collagen
injections. Medicine [on-line]. Available at: http://www.
emedicine.com. Accessed August 10, 2007.
3. Klein AW. The art and architecture of lips and their enhancement with
injectable fillers. In: Klein AW, editor. Tissue augmentation in clinical
practice. New York, NY: Taylor & Francis; 2006. p. 337–45.
4. Sengelmann RD, Tull S. Dermal fillers [on-line]. Available at:
http://www.emedicine.com/derm/topic515.htm. Accessed July 3, 2007.
5. Klein AW. In search of the perfect lip: 2005. Dermatol Surg
2005;31:1599–603.
6. Carruthers JDA, Carruthers A. Facial sculpting and tissue aug-
mentation. Dermatol Surg 2005;31:1604–12.
7. Shrout PE, Fleiss JL. Intraclass correlations: uses in assessing rater
reliability. Psychol Bull 1979;86:420–8.
8. Yaffee RA. Enhancement of reliability analysis: application of in-
traclass correlations with SPSS/Windows v.8. New York: Statistics
and Social Science Group; 1998.
Address correspondence and reprint requests to: Alastair
Carruthers, MD, Suite 820-943 West Broadway, Vancouver,
British Columbia, Canada V5Z 4E1, or e-mail: alastair@
carruthers.net