METHOD OF TREATMENT OF SKIN CONDITIONS OF EYE LIDS

METHODE DE TRAITEMENT D'AFFECTIONS CUTANEES DES PAUPIERES

English Abstract

A method for the hypodermis tightening of fat septa and the reduction of skin tenting, skin lag and skin overhang of the upper and lower eye lids.

French Abstract

L'invention concerne une méthode destinée au resserrement sur l'hypoderme de cloisons de graisse et de réduction du plissage de la peau, du retard de la peau et du surplomb de la peau sur les paupières supérieures et inférieures.

Claims

What is claimed is:
1. A method for improvement of the tired look of human skin comprising
administering citric acid or a salt thereof to a patient in need thereof,
wherein said administering
subcutaneous injection.
2. The method of claim 1, wherein said administering tightens subcutaneous
fat via
strengthening of wall proteins located in the hypodermis of the upper and
lower eye lids to
thereby enhance facial appearance.
3. The method a claim wherein said injection is in the form of one or more
blebs
or boluses.
4. The method of claim 1, further comprising measuring one or more
improvements
in the appearance a the skin with a measuring device.
5. The method of claim 1, wherein said citric acid or salt thereof is
places in the
superficial plane or deep plains of subdermal fat thereby causing skin
tightening by connective
tissue contractions, increased support of subcutaneous tissue, and providing
tensile strength to
protein strands below the dermis.
6. The method of claim 1, wherein citric acid or salt thereof is obtained
from natural
sources is synthetic.
7. The method according to claim 3, wherein said injection is administered
to the
eye lids of the patient in need of treatment.
8. The method according to claim 3, wherein said injection is administered
to
proximal to the orbit of the eyes of the patient in need of treatment.

9. The method according to claim 7, wherein said patient suffers from a
condition of
the eye lids selected from the group consisting of skin tenting impending skin
tenting, lid laxity,
skin sag, ptosis or skin overhang.
10. The method wording to claim 1, wherein said method is administered to a

patient in need thereof either before or after the patient undergoes
blepharoplasty surgery of the
eye lids.
11. The method according to claim 1, wherein said method results in the re-
positioning of fat and/or re-compartmentalizing of fatty tissue in the eye
lids of the patient
undergoing said method.
12. A composition for treatment of conditions of the eye lids of human
patients in
need of treatment thereof, comprising 10% of 3.2% sodium citrate buffer, 36.6%
isotonic water,
45% sodium chloride, 6.4% glycerol and trace electrolytes wherein said
solution has a neutral
pH.
13. The composition according to claim 12, wherein said composition
has a viscosity
to the viscosity of water at 20 to 25°C.
14. The composition according to claim 12, wherein said composition is
used to treat
certain conditions of the eye lids selected from the group consisting of skin
tenting, impending
skin tenting, lid laxity, skin sag, ptosis or skin overhang.
15. A kit comprising
a. a pre-filled intravenous vial containing a pre-determined amount of
either sodium citrate powder or a solution of sodium citrate;
b. an intravenous vial containing a prepared solution of isotonic
water, sodium chloride, glycerol and select electrolytes;
c. an injector to reconstitute the sodium citrate powder
or solution
with the prepared isotonic water/sodium chloride/glycerol/electrolyte
solution; and
9

d. one or more syringes to administer the reconstituted
components.
16. The method according to claim 3, wherein said injection is given to the
patient in
a 10 ml dose.
17. The method of claim 2, wherein said method is used for cosmetic
purposes.
18. The method of claim 17, wherein said method results in the reduction
of the
appearance of fine lines, wrinkles and pores of the patient being treated with
the method.
19. The method of claim 2, wherein said method is used as a preventive
measure in a
patient in need of such treatment wherein said patient suffers from a skin
condition of the eye
lids selected from the group consisting of skin tenting, impending skin
tenting, Iid laxity, skin
sag, ptosis or skin overhang which can result in the impairment of the vision
of the patient if said
condition or condition are left untreated.

Description

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METHOD OF TREATMENT OF SKIN CONDMONS OF EYE LIDS
STATEMENT AT a: THE RICiTITS TO INVENTIONS MADE UNDER FEDERALLY
SPONSORED RESEARCH AND DEVELOPMENT
[00011 This invention was not made whit government support.
FIELD Of THE:INVENTION
100021 This invention relates to a method of the treatment eye lids with
non-
surgical blepharopla.sty by injection torevette.Skin tenting and upper eyelid
overhang and
lower lid laxity.
BACKGROUND
1Ø0031 Overhang:and tenting of the skin in the upper and lower lids of the
eyes are
uniqUe phenomena that can occur in individuals that are not of an advanced
age. The.
Skin in thenpPer: and tower lids of the eyes can be resistant to eye creams
for the
:reduction ofthe presentation of skin tenting, overhang and Way:: There are no
approved
or figoronsly evaluated non-surgical alternatives for treatment of these
conditions directly
at the 'So**, i.e. the. upper and lower lids. Surgical alternatives include
various forms Of
upper and lower lid blepharopIasties where incisions are made and fat is
surgically teased
out of candidates. All surgeries, however, are associated with the known risks
of
anesthesia, infection, bleeding, bruising, scarring, as well as the
possibility:Of:Nor
outcome and the expected discOnIfOrt and "doWn-time" for the patierit4
:Presently, there
are no injections for the upper and lOwer lids that reverse skin tenting,
laxitn overhang,
sag or puffiness. There has been hesitation in the market to date for
injections:into the:
tissue proximal to the orbits:of the eyes. Injections into this anatomical
sight Increase the
risk of causing blindness in the patient. None of the cosmetic substances
currently in the
cosmetic:injection market can be injected into the eye lids or the tissue
proximal to The
orbits of the eyes. There is a need in the market, therefore, for a non-
surgical alternative
to address *it) conditions of the eye lids which does not pose the risk of
causing
blindness. õA eitme solution however, could be used to successfully treat skin
eonditiOns
of thev.YellidS without the risk of causing blindness ill patients. The demand
for:non-
surgical eye:Corr-000 iS: very highirt:0*vosmetic market.

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100041Th spite of procedural risks, the growing appeal of cosmetic medical
treatment of
said PtoCedUres is a testament to the psychological importance of body image
and the
benefiCialoutcomes of these procedures, as perceived by the patients who seek
them.
However, the significance of a product that corrects signs of pen-orbital
aging with little
to no risk is significant.
BRIEF DESCRIPTION OF THE INVENTION
106051 The present in$41tWt:is directed to a method for the non-surgical
reduction of
Localized loose skin in the upper and. lower lids that is associated with the
normal aging
loss of the integrity of the derthiS-that supports the epidermis. The upper
lid tenting and
overhang and 16*g:11d:tenting, overhang and laxity can give the appearance of
one
looking tired when not in particular, a treatment for skin tenting, lid
laxity, sag and
overhang in the upper and lower lids Ofthe eyes with an aqueous solution of
citric acid
with a viscosity consistent with water at 26 to 25 C.
D.MAIUD DM:Rip-TM OF THE INVENTION
100061 The Invention provides a method fOr improvement of the tired look of
human skin
of the eye lids cOmprising administering citric acid or a salt thereof to a
patient in need
thereof; wherein the administering is a submitaneouS injection. The method
tightens
subcutaneous fat via strengthening of wall proteins:located in the hypodemils
of the skin
of the upper and IoWer eye lids to thereby enhance facial appearance. The
injection is,
for example, in the form of one or more large blebs or small boluses. The
method may
also include an additional step of measuring one or more improvements in the
appearance
of the skin with a measuring device. When the citric acid:or salt thereof is
placed in the
superficial plane or deep plains of sulxlermal fat, it causes skin tightening
by connective
tissue contractions, increase support of the subcutaneous tissue, and tensile
strength to
protein strands below the derinis. 'The citric acid or salt thereof may he
either natural or
betic
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100071 The cOnlpositions, treatment schedules and methods of using said
compositions
discovered by the inventor effectively remove the effect of tenting or
impending tenting
of the upper and lower lids.. Generally speaking, tenting and impending
tenting and
tented skin ptosis of the upper and lower:lids of the eyes are a well-known
beauty
problems; problems that can progress to visual impairment if treatment to
reverse the
presentation of the tented and hanging skin is delayed. In addition, the
effect of
tightening tented and hanging skin with .subcutaneous injections repositions
fat and re-
compartmentaliz.es fatty tissue in its more anatOinically correct position.
[00081 Citrate constituted with isotonic water and dextrose can stimulate
elastin tensile
strength below the dermis and above and below the muscle to tighten skin,
decrease the
appearance of aging, and contour deficiencies, fine lines and wrinkles.
Citrate is found in
the serum of individuals. but also can be manufactured and processed,
[00091 The composition of the instant application is based on 100 volume
percent
calculations. In:particular, the composition of the instant application is
comprised of:
volume percent: 3.2 % sodiumeitrate buffer. In the preferred embodiment,
aPPr*irt1401Y-10911.410r$Odiurncitrate buffer is used. Citric acid, having the
loin-mill.
CH2C00}1
tiOCC0014
etntobli,: May also be nsed.
The 11 4:sodium citrate :buffer or citric acid is combined together with
90 volume permit: :364 %isotonic miter, 45% sodium chloride and 6.4% glycerol
with.
trace electrolytes.
[00101 The invention also encompasses a kit. The kit includes the following
items 1),
sodium citrate powder. or a solution thereof, pre-loaded into a 20 cc
intravenous vial for.
dispensing, 2). an 8 10 10 (*.Syringe of a liquid volume comprising isotonic
water,
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sodium chloride, glycerol and trace electrolytes; and an injector device to
reconstitute'the
dry elements. The injector, mixes the Ingredients back and forth hetvveen two
10 cc
syringes until the formula is reconstituted to a dose of I Oml prior to
administration.
100111 The mixture should have a neutral pH priorloinjection. In addition, the
prepared
solution should exhibit the viscosity of water at 20.to 2C at the tiineof
injection.
OM The cOrtiPOsition attic instant application tor the subcutaneous reversal
of skin
'tenting; snjag:of the upper andlor lower lid shot 14 be administered only by
competent
plastiesttrgeons, dermatologists or other medical doctors and their eligible
licensed staff.
Injections into the sub-dermal fat tissue in patients having skin tenting, sag
or lag of the
eye lids wilt tighten and thicken the subdermal fat bands and the hypodermis
thereby
reducing the appearance of fine lines, wrinkles, and pores of the eye lids.
190131 Formulations suitable for administration, conveniently comprise sterile
aqueous
solutions of the active ingredient(s). Preparations may be sterilized by, fOr
example,
filtration through a bacteria-retaining filter, by incorporating sterilizing
agents into the
compositions, by irradiating the compositions, or by heating the compositions.

Preparations can also be manufactured in the form' of sterile solid
compositions which
can be dissolved in sterile water or some other sterile injectable medium
immediately
before use. The formulation may be presented in Wit or multi-dose containers.
for
example, sealed ampoules or vials,
PcAMPUS
100141 Prior to treatment, phOtographs are taken Of the: patients= eyelids. An
initial
treatment period involves up to 2 to 3 treatments involving an initial
treatment with
usually two subsequent follow-up treatments, i.e. a follow-up treatment and a
follow-up
to the follow-up treatment. When the appearance of the correction of the
subcutaneous
wall protein deficit of the upper and tower lids is observed, treatment is
usually halted.
At the initiall treatment session, the consulthnt discusses the intended goals
with the
patient and then determines ifthe patient is a candidate for the follow-up to
the follow-pp
treatment. The provider determines the appropriate number of milliliters of
citric
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solution tabe.injeeted into the defective spaces of the subdermal fat planes.
on average a.
range of 2 nits to 1.2 nils of citric add solution is. employed, During
treatment, a
hypodermic need is used to inject the citric acid with sterile water as an
aqueous mixture
. .
in.a.micro droplet and .microlluidie pattern into the defective space in the
orbital lids
targeting the preapOneurotic.fatpads, medial fat pads, temporal fat pads,
medial fat pads
=
as =ell'as the fattYcell'ilayers. The solution Immediately reabsorbs into
sitbdennal
planes. Residual swellingWill be appreciated for 24 hours followed by
reabsorption of
the solution. The initial, local inflammatory response heals at a.varying rate
depending
On the individual patient with the majority of pati.ent.s.-ItcalingtOmpletely
within two
weeks or less. 'Results from the treatment can be appreciated in 4 to 6 weeks
With
maximum results in 12 months and beyond. Blood test can he used to monitor the
dermal
response to thetreattrient. Before and after photography is used to consult
with the
recipient in one month, three months; 12 months as recommended visits and a 24-
month
visit with.photography is optional.
100151 Example 1...:.
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