Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Reexamination Certificate
1999-08-24
2002-03-19
Russel, Jeffrey E. (Department: 1653)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
C514S844000, C514S906000, C604S511000, C604S522000
Reexamination Certificate
active
06358917
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to cosmetic uses of neuroparalytic toxins.
BACKGROUND OF THE INVENTION
Marionette lines are cosmetic defects of the human face often caused by a loss of dermal collagen in the lower lips and chin area as a result of aging. These lines are usually accompanied by a downturn at the corners of the mouth, producing a “sad” appearance, hence the term “sad mouth”. In this condition, the horizontal symmetry of the mouth is offset in a downward or inferior direction as a result of the downturn at the corners of the mouth.
Some facial wrinkles and unsightly facial expressions are due to overactivity of the underlying facial musculature. Neuroparalytic toxins have been used for treatment of wrinkles and in other treatments for facial rejuvenation. A toxin capable of blocking neuromuscular activity is administered to a facial muscle responsible for the facial defect or lesion. Resulting paralysis of the facial muscle alleviates the facial defect. The preferred toxin for cosmetic use is
Botulinum
toxin (BTX).
BTX, produced by the bacterium
Clostridium botulinum
reversibly paralyzes striated muscle when administered in sub-lethal doses. BTX has been used in the treatment in a number of neuromuscular disorders and conditions involving muscular spasm including various forms of dystonia, hemifacial spasm, tremor, spasticity (e.g. resulting from Multiple sclerosis), anal fissures and various ophthalmologic conditions (c.f. A. Carruthers et al (1996),
Botulinum
A Exotoxin Use in Clinical Dermatology; Journal of the American Academy of Dermatology 34: 788-797).
BTX is a generic term covering a family of toxins produced by
C. botulinum
comprising up to eight serologically distinct forms (A, B, C
1
, C
2
, D, E, F and G). These toxins which are among the most powerful neuroparalytic agents known (c.f. Melling, J. et al (1988)
Clostridium Botulinum
: Nature and Preparation for Clinical Use; Eye 2: 16-23). Serotypes A, B and F are the most potent. The mode of action is to inhibit the release of acetylcholine by the presynaptic nerve.
BTX-A serotype is available commercially under the trademarks BOTOX™ (Allergan, Inc., Irvine, Calif., U.S.A.) and DYSPORT™ (Speywood Pharmaceuticals, Ltd., Maidenhead, U. K.). The initial cosmetic use of BTX was for treatment of forehead frown lines as reported in J. Carruthers and A. Carruthers (1992) “Treatment of Glabellar Frown Lines with
C. Botulinum
-A Exotoxin”; J. Dermatol. Surge Oncol. 18: 17-21. Subsequently, various facial treatments employing BTX have been reported but use of BTX for treatment of midfacial defects has been limited.
Application of BTX near the mouth has been limited to treatment of neuromuscular disorder. For example, hemifacial spasm has been treated by BTX injection to the zygomaticus muscle but the modeolus adjacent the corner of the mouth is avoided (J. Carruthers and A. Carruthers (1996)
Botulinum
A Exotoxin in Clinical Ophthalmology; Can. J. Ophthalmol. 31: 389-400).
It has been reported that BTX injection to a group of muscles on one side of a patient's face has been used to treat facial synkinesis and vertical asymmetry caused by facial nerve palsy (Armstrong, M .W. J. et al. (1996) “Treatment of Facial Synkinesis and Facial Asymmetry with
Botulinum
Toxin Type A Following Nerve Palsy”, Clin. Otolaryngol. 21:15-20). In the latter procedure, the levator anguli oris, zygomaticus major, rizorius and depressor anguli oris muscles associated with the mouth together with various muscles associated with the eye on the normal side of a patient's face were all treated as a group in order to affect the entire vertical symmetry of a patient's face to compensate for effects of nerve palsy on the untreated side of the face.
While BTX treatment of the platysma muscle has been performed for treatment of neck lines and banding, it has also been noted that injection of BTX into the platysma produces an uplift of the mouth (F. S. Brandt and B. Bellman (1998) Cosmetic Use of
Botulinum
A Exotoxin for the Aging Neck; Dermatol. Surg. 24: 1232-1234). Injection of BTX into the point of the chin has also been done for treatment of prominent mental crease (A. Carruthers and J. Carruthers; “Cosmetic Uses of
Botulinum
A Exotoxin”; In: James, W. D. et al Eds.
Advances in Dermatology
(1997) Mosby-Yearbook, Chicago: at pages 325-48).
The inventors have now found that “sad mouth” may be treated by simultaneous bilateral BTX injection to depressor anguli oris (triangularis) muscle (termed herein DAO) thereby affecting the horizontal symmetry of the mouth, without embarrassment to the appearance and function of the mouth. The normal function of the patient's lips is not impeded.
SUMMARY OF THE INVENTION
This invention provides the use of
Botulinum
toxin (BTX) to cause paralysis of a depressor anguli oris (DAO) musculature in a patient to alleviate downturn at corners of the patient's mouth.
This invention provides A method of alleviating downturn of corners of a patient's mouth comprising:
a) locating a depressor anguli oris (DAO) muscle adjacent each corner of said mouth; and
b) injecting into a DAO adjacent each corner of the mouth, a quantity of
Botulinum
toxin (BTX) sufficient to cause paralysis of a DAO.
In this invention, BTX is simultaneously injected into each DAO adjacent each corner of the patient's mouth. By simultaneously, it is meant that the injection into each DAO occurs as part of the same treatment, although a DAO on one side of the mouth may be selected for injection before the other DAO during a treatment session.
REFERENCES:
patent: 5401243 (1995-03-01), Borodic
Bikhazi et al. Refinement in the Rehabilitation of the Paralyzed Face . . . Otol. Head Neck Surg. vol. 117, No. 4, pp. 303-307, Oct. 1997.*
Garcia et al. Cosmetic Denervation of the Muscles . . . Dermatol. Surg. vol. 22, pp. 39-43. 1996.*
Guyuron et al. Aesthetic Indications for Botulinum . . . Plast. Reconstr. Surg. vol. 93, No. 5, pp. 913-918, Apr. 1994.*
Song. Botulinum Toxin Type A Injection . . . Annals Pharmacotherapy. vol. 32, pp. 1365-1367, Dec. 1998.*
Wieder et al. Understanding Botulinum Toxin. Dermatol. Surg. vol. 24, pp. 1172-1174, 1998.*
Armstrong et al. (1996). “Treatment of facial synkinesis and facial asymmetry with botulinum toxin type A following facial nerve palsy”Clin. Otolaryngol., vol. 21: 15-20.
Brandt et al. (1998). “Cosmetic Use of Botulinum A exotoxin for the Aging Neck”Dermatol. Surg., vol. 24: 1232-1234.
Carruthers, (1999). “Botulinum Toxin for Midfacial Defects” 57thAnnual Meeting American Academy of Dermatology, pp. 21-22.
Carruthers et al. (1998). “The Adjunctive Usage of Botulinum Toxin”Dermatol. Surg., vol. 24: 1244-1247.
Carruthers et al. (1998). “Clinical Indications and Injection Technique for the Cosmetic Use of Botulinum A Exotoxin”Dermatol. Surg., vol. 24: 1189-1194.
Carruthers et al. (1998). “History of the Cosmetic Use of Botulinum A Exotoxin”Dermatol. Surg., vol. 24: 1168-1170.
Carruthers et al. (1996). “Botulinum A exotoxin in clinical ophthalmology”Can. J. Ophthalmol., vol. 31(7): 389-400.
Carruthers et al. (1994). “Botulinum Toxin in the Treatment of Glabellar Frown Lines and Other Facial Wrinkles” inTherapy with Botulinum Toxin(Jankovic et al. eds.) Ch. 46: 577-595.
Klein (1999). “Botulinum Toxin for the Aging Face” 57thAnnual Meeting American Academy of Dermatology, pp. 20-20C.
Hoefflin (1998). “Anatomy of the Platysma and Lip Depressor Muscles”Dermatol. Surg., vol. 24: 1225-1231.
Carruthers Alastair
Carruthers Jean D. A.
Bozicevic, Field & Francis
Field Bret E.
Russel Jeffrey E.
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