Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
2001-03-29
2002-08-27
Jarvis, William R. A. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
C514S415000
Reexamination Certificate
active
06440994
ABSTRACT:
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
Not applicable
REFERENCE TO A “MICROFICHE APPENDIX”
Not applicable
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to acne and other inflammatory skin diseases. More particularly, the present invention relates to methods of treating acne and other inflammatory skin diseases including, but are not limited to, acne vulgaris, acne rosacea, acne conglobata, sebaceous cysts and hidrandenitis suppurativa through the oral administration of at least one drug selected from the group consisting of anti-leukotriene agents, and anti-histamine agents. These include, but not limited to, leukotriene antagonists, blockers, and inhibitors, as well as histamine antagonists, blockers, and inhibitors.
2. General Background of the Invention
Acne vulgaris is a dermatological disorder that affects 17 million Americans with a prevalence rate exceeding 85% in teenagers, declining to about 8% in 25 to 34 year olds, and to 3% in 35 to 44 year olds
8
. It is multifactorial and its course varies with cause and age. “There is no disease that produces more psychic trauma, maladjustment, insecurity, and feelings of inferiority than does acne.”
13
For many family physicians acne vulgaris is a very complex and challenging illness due to its inconsistent and often mutable response to treatment. All too many physicians are aware of the insidious nature of this disease and the intense emotional or physical disturbance resulting from acne. No other malady has as its consequence such intense feelings of inferiority, maladjustment and insecurity. The majority of cases seen in the outpatient clinical arena are those that have either been previous treatment failures or those that are presenting for re-treatment because of ongoing medical noncompliance. Often patients are disinclined to continue a chronic, multi-drug treatment regimen because of the potential for developing undesirable side effects, notwithstanding, the assumption of burdensome medical risks. Avoidance of treatment measures usually results in predictable exacerbations of acne lesions and a depreciative outcome, whereas treatment tolerance and potential adversity is rewarded with success.
Recently several authors have reviewed and summarized the treatment options for acne vulgaris.
8, 10
Although effective treatment is available for both short and long term management of acne vulgaris, a strategy for oversight and individualization is essential as relapse is not uncommon; nonetheless, satisfactory results are not guaranteed with the use of any one of the currently available drugs alone. Although the medical causes of acne vulgaris are not known, most patients can be managed with a variety of drugs that have been developed recently. However, results vary based on one's particular choice of chemotherapy or method of medical management. Although many effective pharmaceutical preparations, both prescription and nonprescription, are currently available for use in the treatment of acne vulgaris, no one drug appears effective against all distinctive types of acne and most preparations are laden with significant side effects. Comedolytic agents, for example, in their attempt to promote comedonal drainage cause significant skin irritation. Topical antibiotics decrease the number of mild to moderate inflammatory lesions by inhibiting the growth of
p. acnes
and are also associated with skin irritation, dryness, and potential antibiotic resistance. Oral antibiotics are the standard for treating moderate to severe acne lesions, however, superinfection may occur and long-term use requires routine laboratory monitoring. Hormones in their attempt to decrease sebum production are not without side effects and are usually reserved for females. Oral Vitamin A acid derivatives, although very effective, are only approved for severe nodular acne and commonly exhibit serious adverse reactions.
8
Anti-infectious agents, have also been used as a treatment for acne and other inflammatory skin diseases. Although used quite often in family practice and other medical settings, anti-infectious agents at doses effective for other diseases do not completely eradicate acne within a reasonable period of time. Even at the higher doses of anti-infectious chemotherapy used for more aggressive diseases, these anti-infectious agents do not completely clear acne.
I note here that acne appears to be more inflammatory than infectious, inflaming the face surround the pilosebaceous unit and only “infecting” a single pilosebaceous unit. Acne is not characterized by a classic cellulitis that would assume to be migrating from the microabscess region. Rather, it develops a perilesional inflammatory reaction that persists and remains insidious until medical intervention occurs. If acne were indeed an “infectious” disease, left untreated we would expect it to spread to contiguous tissue creating a substantial problem. However, it never appears to do so.
In addition, the currently available treatments and management of acne and other inflammatory skin diseases using antibiotics appears to violate basic medical principles. Acne is a characterized as a microabscess. An abscess is typically treated by incision and drainage, not by antibiotics.
Propionibacterium acnes
(
p. acnes
) is an anaerobic diptheroid organism that does not appear to cause disease in any other areas of the human body. Thus,
P. acnes
should not be perceived as a primary pathogen but rather as an opportunist that becomes entrapped in the pilosebaceous unit. When entrapped, an anaerobic environment is created. This allows the bacteria to multiply, and pustie to form which eventually causes an inflammatory response in the individual. Certainly, when this occurs antibiotic treatment is useful to remove the growing bacteria and accounts for some of the limited success seen in patients treated with antibiotics.
What is needed is a treatment that is effective against all distinctive types of acne and a variety of other inflammatory skin diseases and is not laden with significant side effects.
Since the mid 1970's medical research has emphasized and shown substantial evidence that a temporary excessive dihydrotestosterone production is implicated in the pathogenesis of acne vulgaris, androgenetic alopecia, idiopathic hirsutism and benign prostatic hypertrophy
7
. The studies by Sansoni and Mauvais-Jarvis clearly associate a local increase in dihydrotestosterone formation with the development of acne,
7
and skin functions such as sebum secretions (Strauss and Pochi, 1963) and body hair growth are well known to be under androgen control
4
. The special article by Price in 1975 suggests that with the proper antiandrogen the highly desirable effect of reducing excessive dihydrotestosterone formation by blocking or selectively inhibiting testosterone 5 alpha reduction should have little systemic effect, and the psychological and other important roles of testosterone itself should not be affected
7
. Nonetheless, current therapy utilizing pharmacological agents that exhibit antiandrogenic activity have failed to live up to earlier expectations in the management of these diseases. For instance, the Type II 5 alpha reductase specific inhibitor Finasteride (Propecia), indicated for the treatment of androgenetic alopecia in men, is contraindicated in women and children and is associated with considerable precautions and adverse reactions such as two fold elevations in serum prostatic specific antigen and decreased labido, erectile dysfunction and ejaculatory dysfunction respectively
6
.
The following U.S. Patents are incorporated herein by reference: U.S. Pat. No. 6,034,228 Human signal transduction serine/threonine kinase, U.S. Pat. No. 6,034,057 Peptide inhibitors of fibronectin, U.S. Pat. No. 6,034,056 Fibronectin adhesion inhibitors, U.S. Pat. No. 6,008,223 Therapeutic compounds, U.S. Pat. No. 5,998,444 Piperidinyl compounds as NK1 or NK2 antagonists, U.S. Pat. No. 5,993,859 Pharmaceutical agents, U.S. Pat. No. 5,990,130 Therapeuti
Garvey, Smith, Nehrbass & Doody, L.L.C.
Jarvis William R. A.
Kim Vickie
Nehrbass Seth M.
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