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IIIHIII US005505949A United States Patent (19) 11 Patent Number: 5,505,949 Benitez (45) Date of Patent: Apr.Pr

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IIIHIII US005505949A United States Patent (19) 11 Patent Number: 5,505,949 Benitez (45) Date of Patent: Apr.Pr IIIHIII US005505949A United States Patent (19) 11 Patent Number: 5,505,949 Benitez (45) Date of Patent: Apr.pr. 9,9, 1996 54 TOPCAL TREATMENT FOR ACNE Primary Examiner-Jyothsna Venkat Attorney, Agent, or Firm-Michael I. Kroll 76) Inventor: Juan E. Benitez, 911 S. Airport Dr., Weslaco, Tex. 78596 (57) ABSTRACT The present invention relates to a topical acne cream having 21 Appi. No.: 322,691 primary ingredients such as: clortrinazole being an anti fungal ingredient usually termed fungicidal due to its char 22 Filed: Oct. 13, 1994 acteristic of killing fungus when they come in contact with (51) Int. Cl. ............................. A61K 748 the substance, betamethasone dipropionate being an anti 52 U.S.C. .424,401. 514859 inflammatory ingredient; and salicylic acid being an anti 58 Fi Elid Ofs C2C- h .............................. 424/401. so reducesseptic/antibacterial?keratolytic inflammation caused by substancea person’s body'swhich immunerapidly reaction to acne bacteria as well as optional secondary 56 References Cited ingredients such as binders, emulsifiers and fillers which U.S. PATENT DOCUMENTS may be present individually and in combination. 4,557,934 12/1985 Cooper .................................... 424/28 1 Claim, 2 Drawing Sheets U.S. Patent Apr. 9, 1996 Sheet 1 of 2 5,505,949 U.S. Patent Apr. 9, 1996 Sheet 2 of 2 5,505,949 18 20 22 CLOTRMAZOLE BETAMETHASONE SALCYLC DIPROPIONATE ACD TOPCAL 10 ACNE CREAM BNDER FILLER EMULSIFIER 5,505,949 1. 2 TOPICAL TREATMENT FOR ACNE Acne vulgaris can appear in many clinical varieties. The mildest case manifests comedones on oily skin and is called acne comedo. BACKGROUND OF THE INVENTION Papular acne is another variety of acne which has many inflammatory papules. Field of the Invention This form of ache is common in adolescent skin, but it can be seen in all ages. The papular inflammatory form of acne The present invention relates to the field of treating the can progress to an indurated, deeper, and destructive form skin condition known as acne. More specifically, the present known as acne indurata. These lesions can produce severe invention is concerned with the prophylactic or therapeutic 10 scarring and can be quite deep seated and destructive. topical treatment of acne. Even more specifically, the present Steroid acne vulgaris can occur when oral corticosteroids invention is concerned with the topical treatment of such or topical steroids are used and occurs as inflammatory skin disorders as acne vulgaris, other acneiform dermal follicular papules. When oral corticosteroids are ingested, disorders, e.g. preadolescent acne, acne rosacea (now known the inflammatory papules are usually sudden in appearance as rosacea), premenstrual acne, acne venenata, acne cos 15 and can cover the chest, back, arm, and face. When topical metica, pomade acne, acne detergicans, acne cosmetica, corticosteroids are used for more than two weeks, a localized acne excoriee, gram negative acne, steroid acne, acne con inflammatory apular response can develop which can pro globata, or nodulocystic acne. The present invention can ceed to a granulomatous chronic reaction known as steroid also be used for topically treating certain other types of aCC OSaCCa. acneiform dermal disorders, e.g. perioral dermatitis, sebor 20 rheic dermatitis in the presence of acne, gram negative Premenstrual acne can occur in a large number of men folliculitis, sebaceous gland dysfunction, hiddradenitis sup struating women as a papular and pustular acne vulgaris, purativa, pseudo-folliculitis barbae, or folliculitis. approximately one week prior to menstruation. There is a The present invention relates to topically applied medici body of evidence that implicates a surge in progesterone as nal compositions, and more particularly refers to such com 25 the mediator of premenstrual acne. positions having active topical medicinal ingredients, and Preadolescent acne is divided into neonatal, infantile, and additionally having LYCD in amounts sufficient to act with childhood forms of acne. The neonatal form is limited to the the other active ingredients to provide synergistic therapeu first few weeks of life. It usually develops a couple of days tic results. after birth. It more commonly afflicts males and reveals The present invention concerns benzoyl peroxide quater 30 transient facial papules and pustules which can clear spon nary ammonium lipophilic salicylate based pharmaceutical taneously in a few days or weeks. The stimulation of and cosmetic compositions and their use especially in treat neonatal sebaceous glands by circulating maternal progest ment of acne. erone appears to be the cause. If the acne persists beyond the first month of life, the acne 35 is called infantile acne and can extend into childhood, DESCRIPTION OF THE PRIOR ART adolescence, and adult life. The childhood acne can result Acne vulgaris is a common disease which afflicts approxi from a persistent infantile acne or can develop de novo after mately 90% of all teenagers, and, not uncommonly, affects age two. This form of acne is uncommon, but it has more of men and women in their twenties or thirties or may persist a male predilection. It is characterized by comedones com in adults for many years. Acne vulgaris most commonly 40 monly in groups, papules, pustules, and, rarely, cysts. This occurs on oily areas of the skin with high sebaceous gland condition can extend from a few weeks to several years and concentration. The areas of high sebaceous gland concen can develop into pubertal acne. tration are the face, ears, retroauricular areas (e.g. behind the Acne venenata is by definition a comedonai or papular ears), chest, back, and occasionally the neck and upper arms. acne which occurs after exposure to chlorinated hydrocar 45 bons (chloracne), cutting oils, petroleum oil, coal tar, and Acneiform eruptions can occur whereverthere is a pilose pitches. baceous unit or sebaceous follicle which does include the entire surface of the skin. The basic lesion in acne is the Acne cosmetica is a persistent low grade comedonal comedo commonly known as the blackhead. The comedo is and/or papular and pustular acne that occurs usually on the created by retention of layers of dead skin known as keratin 50 chin and cheeks of adult women due to oil-based cosmetics, in the lining of the follicles. In addition to hyperkeratosis i.e. foundations, facial creams, and sunscreens. (which is thickening or retentative layering of keratin), there Pomade acne is a type of acne cosmetica which appears is an accumulation of sebum which is the lipid-laden product to occur almost exclusively in black persons who apply of the sebaceous gland. The cells of the sebaceous glands in grease and oil to scalp hair and the face as a grooming aid. which sebum originates are the sebocytes. The combination 55 The lesions are predominately comedonal acne and can of the keratin and the sebum produces a plugging of the develop into inflammatory acne papules, depending upon mouth or opening of the follicular canal, and papules are the chronicity of the pomade use. formed by inflammation around the comedones (plural of Acne detergicans occurs as a type of comedonal acne in comedo). Depending upon the degree of inflammation, patients who use oil-based cleansing soaps. Acne excoriee, pustules, cysts, nodules, granulomatous reactions, Scars, and 60 also known as pickers acne, starts out as a mild form of keloids may develop. papular or comedonal acne which is manipulated or picked Most typical forms of mild acne vulgaris demonstrate the and causes further inflammation, more papules, and some predominance of comedones with the occasional pustules. times Scars, pitting, and atrophy of the skin. Pustules and papules predominate in more severe cases. Gram negative acne, sometimes called gram negative These can heal with scar formation; that is, fibrosis of the 65 folliculitis when it extends to the neck, arms, legs, and trunk, lesions which are deep and penetrating. In moderately active is a form of an inflammatory papular, follicular, and pustular cases, larger cystic lesions can develop. response to gram negative organisms including Entero 5,505,949 3 4 bacter, Klebsiella, Escherichia, Proteus, Serratia, and frequently by gram negative bacteria discussed hereinabove Pseudomonas. The most characteristic lesion on the face are with respect to gram negative folliculitis. Superficial pustules, or papulo-pustules (which is a combi Perioral dermatitis is a common papular inflammatory nation of a papule and pustule). The face can show diffuse eruption which is confined around the mouth. It most erythema and inflammation surrounding these pustules and commonly afflicts women in their early twenties to middle juicy papules or papulo-pustules. thirties, but it can be seen in adolescents and more mature The gram negative acne is usually highly resistant and adults. usually occurs in patients who have bad inflammatory Hiddradenitis suppurativa is a suppurative (chronic) and papular acne for long periods or who have been treated with cystic disease of apocrine gland regions of the skin, includ long term oral administration of antibiotics such as tetracy 10 ing the axillae, perineum and groin. cline, erythromycin, or minocycline or topical antibiotics There is a genetic tendency to acne, in particular acne such as topical clindamycin or topical erythromycin. Sub congoblata which is a deep cystic and sinus forming type of sequent to the oral administration of tetracycline or eryth acne. This condition is essentially a deep, aggressive form of romycin, oral administration of amoxicillin, ampicillin, and cystic acne occurring in the apocrine gland regions. Topical trimethoprim-sulfomethoxazole has been shown to be effec 15 administration of clindamycin has been used to treat this tive in treating this disease. (Poli, F., Prost, C., Revuz, J., form of cystic acne. Gram-negative Folliculitis, Ann. Dermatol. Venereol., The etiology of acne vulgaris and related disorders as 115:797-800, 1988). discussed above is not completely known in every detail.
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