Drug – bio-affecting and body treating compositions – Inorganic active ingredient containing – Alkali or alkaline earth chloride
Reexamination Certificate
1996-03-11
2002-03-05
Moezie, Minna (Department: 1617)
Drug, bio-affecting and body treating compositions
Inorganic active ingredient containing
Alkali or alkaline earth chloride
C514S859000
Reexamination Certificate
active
06352724
ABSTRACT:
TECHNICAL FIELD
The present invention relates, in general, to a method for the topical treatment of acne and/or rosacea. More particularly, the present invention relates to an improved method for the topical treatment of human skin affected with acne and/or rosacea by gently gliding over the affected skin substantially pure sodium chloride.
RELATED ART
Acne is a skin disorder caused by bacteria that inflames skin glands and hair follicles of humans. Acne typically occurs during the teenage years due to hormonal changes, but occasionally develops as early as the age of nine and sometimes extends well into the age of the mid-twenties. On the other hand, rosacea, which used to be thought of as a type of acne, has more recently been found to be a skin disorder that, in contrast to acne, dilates facial blood vessels in severe cases in humans and typically occurs at the age of about 30 to about 50. It is not known what causes rosacea.
An excellent discussion of the problems of rosacea afflicting those in the 30 to 50 age group can be found in Stern, “You Don't Have to Live with It”,
Parade Magazine
, pp. 8 and 10 (Feb. 19, 1995). Stern also discloses that standard acne medications, when topically applied to rosacea-affected skin, generally irritate the skin and induce rosacea flare-ups. Similarly, agents that dilate blood vessels when ingested, for instance, ethanol (drinking alcohol) and certain medications for high blood pressure, can bring on a rosacea blush when ingested by a person affected with rosacea. Untreated, rosacea can result in swollen veins, scattered lumps, and clusters of pustules on the face. Stern concludes with a brief discussion of treatment of rosacea by ingestion of antibiotics and/or by laser beams directly on the rosacea-affected skin to destroy swollen blood vessels.
Also, Fitzpatrick et al., in
Color Atlas and Synopsis of Clinical Dermatology
, pp. 10-13 (1988) provide information in connection with various treatments for rosacea, which, as noted above, is not a type of acne but can result in pustules just as acne does. Of particular interest within this portion of
Color Atlas and Synopsis of Clinical Dermatology
are the illustrations of the respective rosacea-afflicted faces of two older women, as shown in two respective color photographs labeled as FIGS. 5 and 6.
A method for the treatment of acne-affected skin is disclosed in U.S. Pat. No. 3,867,522 to Kligman and is of interest. The patent describes a method that requires vigorously rubbing on the acne-affected skin of a composition of about 30% to about 60% by weight of discrete crystals of sodium chloride in a carrier base for about 1 to 2 minutes to cause abrasion and debridement of the affected skin. The crystals of sodium chloride must be of an appropriate particle size, typically from about 200 to about 500 micrometers, to cause the abrasion and debridement. Also, so that the sodium chloride crystals may be frictionally rubbed onto the acne-affected skin, the crystals must be present in a carrier or vehicle, such as stearic acid, glycerylmonostearate, propylene glycol, parahydroxybenzoic acid methylester, or sodium laurylsulfate.
U.S. Pat. No. 3,574,854 to Bossard describes a process for providing a soothing effect on skin. More particularly, the process involves applying to the skin an oil-in-water emulsion that is a cream or paste consisting essentially of marine salt (i.e., sodium chloride accompanied by salts of potassium, magnesium, and calcium), colloidal silica, stearyl alcohol or cetostearyl alcohol, lanoin, polyethylene glycol of molecular weight 400-4000 or glycerol, a coloring agent, and water.
Also, of background interest with respect to use of sodium chloride in the treatment of acne is U.S. Pat. No. 4,443,442 to Skillern. This patent discloses a method for treating acne vulgaris requiring the oral ingestion of a combination composition containing sodium chloride together with an acne-controlling compound chosen from methyclothiazide, polythiazide, or trichlormethazide. At the beginning of the '442 patent to Skillern is a comment that U.S. Pat. No. 4,005,198 to Skillern et al. discloses a method for treating acne vulgaris by oral ingestion of one of these three azide drugs together with the antibiotic, tetracycline. However, as further noted in the '442 patent to Skillern, these three azide drugs, when ingested orally, are also known to have diuretic side effects that result in excretion of sodium chloride during urination. The invention in the '442 patent to Skillern is the discovery that oral ingestion of the combination of sodium chloride with one of these three azide drugs not only enhances the effectiveness of the drug for use in treating acne, but also decreases the incidence of the diuretic side effect. Optionally, an antibiotic, such as tetracycline, is orally taken together with the composition of sodium chloride and azide drug.
Nevertheless, it is still desirable to find a method of treating acne-affected skin and/or rosacea-affected skin topically with sodium chloride that does not require abrasion and debridement of the acne-affected skin (which can exacerbate redness and swelling from irritation of the affected skin) and that does not require oral ingestion of sodium chloride (which can result in nausea, dizziness, and hypertension).
STATEMENT OF THE INVENTION
Accordingly, the present invention provides a method for the topical treatment of skin affected with acne, rosacea, or a combination thereof. The method comprises selecting a substantially pure form of sodium chloride and topically applying it to the affected skin by gently gliding it over the affected skin, preferably for about 50 seconds or less, in a manner insufficient to cause abrasion and debridement of the affected skin. In one embodiment of the inventive method, the substantially pure form of sodium chloride is obtained from vacuum granulated sodium chloride that has been compressed.
Also, it is preferred that the substantially pure form of sodium chloride consists essentially of about 95% to about 100% by weight, and more preferably consists essentially of about 98% to about 100% by weight, of sodium chloride as a solid block. Furthermore, the sodium chloride should be free of a carrier, free of other acne-treatment medicaments, and/or free of other rosacea-treatment medicaments.
To assist in a portion of the sodium chloride from the block leaving the block and forming a film or coating on the affected skin, prior to gliding the block of sodium chloride over the affected skin the affected skin is preferably pre-moistened with water, such as from shaving, bathing, splashing water on the affected skin, and the like. Then, the coating of sodium chloride applied to the affected skin is allowed to dry on the affected skin.
Accordingly, it is an object of the present invention to treat acne-affected skin topically with sodium chloride without any concomitant debridement that is typical of topical acne treatments and that can easily result in red, irritated skin.
It is a further object of the present invention that sodium chloride used in the skin treatment is not orally ingested, and thereby the present invention obviates the risk of nausea, dizziness, or hypertension that can result from oral ingestion of too much sodium chloride.
It is a feature of the present invention that the sodium chloride treatment is also useful in the topical treatment of rosacea, in addition to the topical treatment of acne, which is untrue of standard acne topical medications, which when applied to rosacea-affected skin generally irritate the skin and induce rosacea flare-ups.
Thus, it is an advantage of the present invention that persons who have both acne and rosacea, as well as persons who have only rosacea or who have only acne, may use the inventive method.
REFERENCES:
patent: 3526508 (1970-09-01), Andelfinger et al.
patent: 3749579 (1973-07-01), Andelfinger et al.
patent: 3808310 (1974-04-01), Andelfinger et al.
patent: 4088760 (1978-05-01), Benson et al.
patent: 4943432 (1990-07-01), Biener
patent: 5
Bass Ralph L.
Taylor Lesli A.
Bahar Mojdeh
Jenkins & Wilson, P.A.
Moezie Minna
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