Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Nitrogen containing other than solely as a nitrogen in an...
Reexamination Certificate
2001-04-20
2003-09-30
Spivack, Phyllis G. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Nitrogen containing other than solely as a nitrogen in an...
Reexamination Certificate
active
06627663
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of The Invention
The present invention relates to the treatment of hemangiomas.
2. Background Information
Hemangioma is the most common benign tumor of infants. They are usually apparent at birth but become evident within the first two weeks. Hemangiomas occur in 5-10% of all children and three times more often in females then males.
Approximately thirty percent of all hemangiomas are visible at birth. The remaining seventy percent become visible within one to four weeks after birth. Hemangiomas occur 5 times more often in females than in males and occur predominantly in Caucasians. Low birthweight infants (less than 2.2 pounds) have a twenty six percent chance of developing a hemangioma.
Approximately eighty three percent occur on the head and neck area. The remaining seventeen percent appear throughout the the rest of the body (both externally and internally). In the early stages some appear either as bluish or reddish spots or flat patches. Rarely is a hemangioma fully grown at birth.
Hemangiomas that are flat and appear reddish in color are called “superficial” and those that are deep beneath the skin and appear bluish in color are called “deep” hemangiomas. When a hemangioma is both deep and superficial it is called a “compound” hemangioma
Hemangioma will grow for the first 8-12 months of life. Growth can be prolific and may appear to change daily. Hemangiomas will begin to regress or involute around 12 months of age. This process may take up to 10-12 years leaving residual scarring.
While all hemangiomas eventually involute the result is not always cosmetically acceptable. Early intervention has been shown to reduce the need for corrective surgery after “involution” has occurred; or to, at least, minimize extensive corrective surgeries in the future. Psycho-social scarring an which occurs when a child has been forced to live with a facial deformity until “involution” has been completed can be avoided by early, aggressive intervention, according to presently known treatment options.
Conventional treatment options for hemangiomas range from surgical excision (followed, in cases of facial or neck hemangiomas, with cosmetic surgery) to systemic corticosteroid treatments, laser, and use of alpha-interferon, Recently, cryosurgery and sclerotherapy, have been proposed additions to the available treatment regimens for hemangiomas.
Each conventional treatment option carries potential side effects. Clearly, surgery always presents risks, whether for infection, unexpected patient reaction to anesthesia, and/or unexcpected aesthetic results.
While systemic corticosteroid treatment is suspected of certain side effects (or, at least, its safety has never been fully substantiated, according to some authorities), regardless of age, steroid treatment carries decided risks if carried on beyond a child's first birthday. Furthermore, hemangiomas do not warrant nor benefit from steroids beyond the first birthday, in part, because proliferation of hemangiomas tends to end by that point anyway. In any event, if steroids are lowered too quickly or given intermittently, “rebound growth” is possible, if not likely. Some investigators have reported other side effects from steroid treatments. In one investigation, children (29 percent) became more irritable, depressed and/or napped less during treatment, although this resolved as treatment was tapered and discontinued. Other short-term side effects included gastric irritation, oral or perineal yeast infection, recurrent otitis media, hypertension, and myopathy.
The disadvantages of sclerotheraphy include the pain of injection, swelling, and psychological strain associated therewith, as well as the danger of necrosis if the sclerosis technique is flawed.
While certain treatments for hemangiomas are considered typically effective, the psychological effects of hemangiomas alone warrant the relentless pursuit of more effective treatment regimens for hemangiomas, whether for use alone, or in concert with existing treatment options. Also, because most patients receiving treatments are infants or small children, patient tolerance for the treatment options becomes of more paramount importance.
In view of the above, a substantial contribution to humanity would come in the form of any new and improved treatment options directed to hemangiomas. Such a new and improved treatment option for hemangiomas would ideally embody characteristics which are beneficial, at least when compared to existing treatment options, with respect to efficacy, long-term side effects, patient discomfort during treatment, and residual aesthetic or cosmetic consequences,
SUMMARY OF THE INVENTION
It is an object of the present invention to provide an improved treatment regimen for hemangiomas.
It is another object of the present invention to provide an improved treatment regimen for hemangiomas, which treatment regimen obviates the need for surgery, steroid treatment, or other treatment modalities with known potential side effects and/or treatment risks or discomfort.
It is another object of the present invention to provide an improved treatment regimen for hemangiomas, which treatment regimen is based on the use of a pharmacological agent known to have minimal potential side effects.
It is another object of the present invention to provide an improved treatment regimen for hemangiomas, which treatment regimen obviates, at least in part, the need for all but a mere topical application of a therapeutic medicament.
In satisfaction fees and related objects, the present invention provides for the treatment of hemangiomas through the periodic topical application of a calcium channel blocker agent which is combined with an agent for facilitating transdermal penetration thereof.
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Easterling W. Jerry
Henry David G.
Spivack Phyllis G.
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