See discussions, stats, and author profiles for this publication at: https://www.researchgate.

net/publication/45721926

Clinical Assessment of a Combination Lip Treatment to Restore

Moisturization and Fullness

Article in Journal of Clinical and Aesthetic Dermatology · December 2009

Source: PubMed

CITATIONS READS

44 1,540

5 authors, including:

Rahul C Mehta Vincent Gotz

AbbVie Adigica Health
107 PUBLICATIONS 1,702 CITATIONS 82 PUBLICATIONS 1,062 CITATIONS

SEE PROFILE SEE PROFILE

Some of the authors of this publication are also working on these related projects:

COPD therapeutics View project

All content following this page was uploaded by Rahul C Mehta on 19 September 2014.

The user has requested enhancement of the downloaded file.

[ORIGINAL RESEARCH]

Clinical Assessment of a Combination

Lip Treatment to Restore
Moisturization and Fullness
a
NATHAN S. TROOKMAN, MD; bRONALD L. RIZER, PhD; cROSANNE FORD, BA;
c
RAHUL MEHTA, PhD; dVINCENT GOTZ, MS Pharm
a
Rocky Mountain Laser Center, Colorado Springs, Colorado; bThomas J. Stephens & Associates, Colorado Springs, Colorado;
c
SkinMedica, Inc., Carlsbad, California; dConsultant, ProPharmaCon, LLC, San Diego, California

ABSTRACT
Objective. To evaluate the efficacy and tolerance of a topical lip-care treatment. Step one of the two-step treatment
is a lip-renewal formulation containing human growth factors, hyaluronic acid and marine filling spheres, emollients, and
a tripeptide palmitoyl-glycyl-histidyl-lysine complex. Step two is a lip-plumper formulation containing niacin, emollients,
and essential fatty acids. Design. Four-week, single-center, open-label, clinical study with clinical assessments at
Baseline, Week 2, and Week 4. Treatment. Subjects wore the lip products at least eight hours every day with a minimum
of three applications per day. Participants. Thirty-two women ages 22 to 40 years with mild-to-moderate lip dryness
and average size lips completed the study. Measurements. Visual grading of the condition of the lips, rating of subjective
irritation, corneometry, digital caliper measurements of lower lip, and digital photography. A self-assessment
questionnaire was also employed to assess patient satisfaction. Results. Clinical assessments showed statistically
significant improvements (P<0.001) in key lip condition parameters after both two and four weeks of use. Key
parameters included lip scaling, cupping, cracking/fissuring, fine lines due to dryness, lip texture/visual roughness, lip
color/rosiness, lip definition/contour, and overall lip condition. Significant increases (P<0.001) were observed in both
corneometer measurements, which confirm the moisturizing benefits, and in digital caliper measurements, which confirm
the lip-plumping benefits. Self-assessment questionnaires showed a 97-percent overall satisfaction rating. No adverse
events were reported during the course of the study. Conclusion. The results from this clinical study demonstrate that
this two-part lip-care treatment product was well tolerated and effective in restoring moisture and fullness to the lips of
female subjects with mild-to-moderate lip dryness. (J Clin Aesthetic Dermatol. 2009;2(12):44–48.)

T
he lips are a central defining feature of the lower face low moisture capacity.3,4 Their red coloration is believed to
as they are distinct from the surrounding skin. The result from a combination of decreased density of keratin
appearance of the lips has a major effect on the and translucency of the tissue allowing the underlying
aesthetic perception of the female face. Full and well- capillaries to be observed.5
defined lips impart a sense of youth, health, and As a result of poor barrier function and low water-
attractiveness.1 Similar to other features of the face affected retaining capacity, the lips are highly susceptible to
by the aging process, aged lips become thin and flat and environmental effects, such as wind, sun, smoking, and
therefore appear less attractive.2 Products that effectively temperature extremes. This environmental damage as well
protect and enhance the lips are desirable aesthetic agents. as certain medications can cause the lips to become dry,
The lips form an extension from the mucosal membrane chapped, and dull in color. In addition to the environmental
to the outer skin. Lips are covered by a thin layer of effects, there are age-related changes to the lips and
stratum corneum and have poor skin barrier function and perioral skin. Wrinkle number and visibility are linearly

DISCLOSURE: Drs. Trookman and Rizer received grant payments as clinical investigators for the study. Ms. Ford and Dr. Mehta are employed
by SkinMedica. Mr. Gotz is a consultant for SkinMedica. Financial support for the study was provided by SkinMedica, Inc.
ADDRESS CORRESPONDENCE TO: Dr. Rahul Mehta, 5909 Sea Lion Place, Carlsbad, CA 92010. E-mail: [email protected]

44 [December 2009 • Volume 2 • Number 12]

related to age, becoming more visible during the fifth and self-perceived and clinically determined average size
decade.6 Histological analysis of the upper lip revealed that lips. Eligible subjects were regular users of lip products
elastic and collagen fibers in the cutis undergo a (clear or colored) at least four times a week. Subjects must
degeneration process during the aging process with have been willing to wear the test products for at least
thinning of the cutis.7 eight hours per day, every day, for the duration of the
A prominent sign of general skin aging is the study, with a minimum application of three times a day.
development of fine lines and wrinkles caused by both Subjects could not have a history of lip injections or lip
intrinsic and environmentally induced aging processes.8 surgery or chronically dry or chapped lip conditions that
Intrinsic aging is a natural process relating to chronological are not improved with the use of lip-conditioning products.
age; whereas, environmentally induced aging results from Subjects agreed not to apply any product (e.g., lipstick, lip
external factors, the most notable of which is exposure to gloss, lip conditioner) to the lips other than the test
sunlight. The main structural changes resulting from both product for the duration of the study. Subjects
types of aging are characterized by a reduction in collagen discontinued use of all lip-enhancement products a
and elastin, together with a loss in hydration. minimum of three days prior to the baseline visit.
Topical growth factors have emerged as novel anti-aging Written informed consent conforming to 21 CFR 50.25
agents.9,10 These natural proteins have been shown in was obtained from each subject prior to study enrollment.
clinical studies to both decrease the appearance of Study design. During the four-week, open-label study,
wrinkles and to stimulate collagen synthesis.10–13 clinical evaluations were conducted at Baseline, Week 2,
The lip care product used in this study is a two-step and Week 4.
treatment. The step one lip-renewal formulation contains Study endpoints. Efficacy. Visual assessment of lip
human growth factors, hyaluronic acid and marine filling parameters (scaling, cupping, cracking/fissuring) were
spheres, emollients, and a tripeptide palmitoyl-glycyl- graded on a scale of 0 to 6 at each clinic visit. Assessment
histidyl-lysine (Pal-GHK) complex. The step two lip- of fine lip lines due to dryness, overall condition, lip
plumper formulation contains niacin, emollients, and color/rosiness, lip definition/contour, and lip texture/visual
essential fatty acids. This combination was designed to roughness were graded on a 10cm analog scale (with half
improve lip texture and condition and to increase lip points allowed) at each clinic visit. Corneometer CM 825
fullness and volume providing a more youthful appearance. (Courage + Khazaka, Germany) measurements to quantify
The purpose of this four-week, open-label, single-center moisture content of the stratum corneum were taken
study was to evaluate the efficacy and tolerance of this (duplicate) with one measurement taken on each side of
novel combination lip system to condition, moisturize, and the lower lip at each clinic visit. A digital caliper
enhance lip volume and definition. measurement (duplicate) was used to evaluate plumpness
of the lower lip at each clinic visit. Digital (Nikon D-100
METHODS camera) macrographs were taken of the lips in a relaxed,
Study population. The criteria for study participation closed position at Baseline and Week 4. Subjects
included healthy women aged 22 to 40 years, with completed a self-assessment questionnaire immediately
Fitzpatrick skin types I to IV, having both mild-to-moderate after initial application and at Weeks 2 and 4 regarding the
dryness of the lower lip as determined by a clinical grader test products.

Figure 1. Mean reductions in fine lip lines and texture/roughness. Figure 2. Mean improvements in condition of the lips.

[ December 2009 • Volume 2 • Number 12] 45

Figure 3. Mean improvements in parameters of lip dryness. Figure 4. Mean improvements in moisturization and plumping of the
lower lip

Safety. Tolerance was assessed by objective and

TABLE 1. Subject self-assessment of lip product attributes after subjective irritation parameters and the reporting of
four weeks treatment (% patients agree or strongly adverse events. Objective irritation (erythema, edema) and
agree)
subjective irritation (burning, stinging, itching, tightness,
and tingling) were graded on a scale of 0 to 3 (with half
PRODUCT ATTRIBUTES AT WEEK 4
points allowed) at each visit.
Subject self-assessment. Subjects completed a self-
assessment questionnaire asking them to rate their
Overall satisfaction (excellent or good) 97% experience using the lip products within minutes of initial
application and at Weeks 2 and 4. Self-assessment
Improved overall lip condition 100% questionnaires were tabulated and a top-box analysis was
performed.
Moisturized lips 100% Statistical analysis. Clinical grading and instrumentation
scores at each visit were statistically compared to baseline
Increased lip volume 81% scores using a paired t-test. Changes from Baseline were
considered significant at the p<0.05 level.
Enhanced color 91%
RESULTS
Improved lip outline/contour 91% Demographics. Thirty-two of the 42 female subjects
who were enrolled completed the four-week study. Nine
Improved lip appearance 97% subjects were disqualified at Baseline; seven subjects
because their lips were too full and two subjects because
Softens fine lines around mouth 78% their lips were not dry enough. One subject voluntarily
withdrew during the study. Subjects were primarily
Lips look and feel healthier 94%
Caucasian (81%) and Hispanic (12%) and were aged 22 to
40 years.
Efficacy. Clinical assessments demonstrated
Helped prevent lip dryness 78%
statistically significant improvements (P<0.001) in all lip-
condition parameters after two weeks and four weeks of
Not oily or greasy 81%
use. These parameters included the following: scaling,
cupping, cracking/fissuring, fine lines due to dryness,
Is good for everyday use 97%
overall condition, color/rosiness, definition/contour, and
texture/visual roughness. See Figures 1 to 3 for
Would use if available 84%
improvements over Baseline in these lip parameters after
two weeks and four weeks of use. Figure 4 illustrates
Made lips feel smoother/softer 94%
statistically significant increases (P<0.001) in corneometer

46 [December 2009 • Volume 2 • Number 12]

measurements and in digital caliper
measurements of the lower lip, which
demonstrate moisturization and plumping
benefits, respectively. Figure 5 shows digital
photographs of subjects taken at Baseline
and after four weeks of treatment. Results of
the top-box analysis of the self-assessment
questionnaires at the end of the study are
shown in Table 1. Overall subject
satisfaction with the lip-care treatment
system at Week 4 was 97 percent.
Safety. The lip treatment system was
well tolerated. No adverse events were
reported during the course of the study.
Only minimal increases in subjective
irritation (burning and tingling) were
observed.

DISCUSSION
Right or wrong, physically attractive
individuals reap many benefits in society
across cultures. Studies have shown that
facial attractiveness is assessed rapidly from
small amounts of visual information.14 The
appearance of the lips has a major effect on
aesthetic impressions of an individual and
on the overall attractiveness of the face.15,16
Traditionally, fuller lips have been
considered more attractive than thin, flat
lips. When lips are full and well defined, they
evoke a sense of youth, health, and
attractiveness. Thin, flat lips imply fragility Figure 5. Photographs of subjects at Baseline and after four weeks of treatment.
and senility.1 Since ancient times, women
have been highlighting their lips, and lipstick is a major perception of the effectiveness of the treatment by the
component of the cosmetics industry. More recently, subject is critically important, a self-assessment
several aesthetic agents claiming to plump the lips have questionnaire assessing product performance showed an
become available to consumers. overall satisfaction rating (excellent or good) of 97 percent.
It has been shown that wrinkles or furrows in and Frequently, more invasive procedures, such as dermal
around the vermilion border affect the color tone, spread, filler injections, are chosen for the immediate and
and pigment remnants of lipstick. As the depth and significant improvements they produce in the lips.
17

number of wrinkles are reduced, the lipstick make-up However these procedures are also associated with certain
appearance assessed by image analysis improves disadvantages, such as a potential risk for complications
significantly. Thus, an optimal lip product should include and a period of recovery time.18 The two-step lip-care
agents that both condition the lip skin to improve texture treatment, which produced significant improvements in all
and reduce surface lines as well as increase lip fullness and lip condition parameters including moisturization and
definition and enhance the natural lip color. plumping, provides a well-tolerated alternative to invasive
In this clinical study, the two-step topical lip-care procedures with no down time.
treatment showed statistically significant improvement in
key lip condition parameters with continued improvement REFERENCES
over the four-week study. Physician assessments of clinical 1. Etcoff N. Survival of the Prettiest: The Science of Beauty.
efficacy demonstrated reductions of fine lip lines and visual New York: Doubleday; 1999.
roughness ranging from 81 to 94 percent at two and four 2. Klein AW. In search of the perfect lip: 2005. Dermatol
weeks, respectively. Improvement rates in color, Surg. 2005;31:1599–1603.
definition/contour, and overall condition ranged from 79 to 3. Ya-Xian Z, Suetake T, Tagami H. Number of cell layers of the
133 percent at two and four weeks, respectively. Physical stratum corneum in normal skin – relationship to the
measurements of the lips using corneometry to assess anatomical location on the body, age, sex and physical
moisturization and calipers to assess lip fullness also parameters. Arch Dermatol Res. 1999;291:563–567.
demonstrated statistical improvements from Baseline. Since 4. Kobayashi H, Tagami H. Functional properties of the
surface of the vermilion border of the lips are distinct from

[ December 2009 • Volume 2 • Number 12] 47

 those of the facial skin. Br J Dermatol. 2004;150:563–567. 12. Ehrlich M, Rao J, Pabby A, Goldman MP. Improvement in
5. Zugerman C. The lips: anatomy and differential diagnosis. the appearance of wrinkles with topical transforming
Cutis. 1986;38:116–120. growth factor beta(1) and 1-ascorbic acid. Dermatol Surg.
6. Leveque JL, Goubanova E. Influence of age on the lips and 2006;32: 618–625.
perioral skin. Dermatology. 2004;208:307–313. 13. Gold MH, Goldman MP, Biron J. Efficacy of novel skin
7. Penna V, Stark GB, Eisenhardt SU, et al. The aging lip: a cream containing mixture of human growth factors and
comparative histological analysis of age-related changes in cytokines for skin rejuvenation. J Drugs Dermatol.
the upper lip complex. Plast Reconstr Surg. 2007;6:197–201.
2009;124:624–628. 14. Olson IR. Facial attractiveness is appraised in a glance.
8. Uitto J. The role of elastin and collagen in cutaneous aging: Emotion. 2005;5:498–502.
intrinsic aging versus photoexposure. J Drugs Dermatol. 15. Fink B, Neave N. The biology of facial beauty. Int J Cosmet
2008;7(2 Suppl):S12–S16. Sci. 2005;27:317–325.
9. Mehta RC, Smith S, Grove GL, Ford RO, et al. Reduction in 16. Bisson M, Grobbelaar A. The esthetic properties of lips: a
facial photodamage by a topical growth factor product. J comparison of models and nonmodels. Angle Orthod.
Drugs Dermatol. 2008;7:864–871. 2004;74:162–166.
10. Mehta RC, Fitzpatrick RE. Endogenous growth factors as 17. Ryu JS, Park SG, Kwak TJ, et al. Improving lip wrinkles:
cosmeceuticals. Dermatol Ther. 2007;20:350–359. lipstick-related image analysis. Skin Res Tech. 2005;11:
11. Fitzpatrick RE, Rostan EF. Reversal of photodamage with 157–164.
topical growth factors: a pilot study. J Cosmet Laser Ther. 18. Hirsch RJ, Stier M. Complications of soft tissue
2003;5:25–34. augmentation. J Drugs Dermatol. 2008;7:841–845.

48 [December 2009 • Volume 2 • Number 12]

View publication stats