US 2005O196469A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2005/0196469 A1 Thys-Jacobs (43) Pub. Date: Sep. 8, 2005 (54) MICRONUTRIENT SUPPLEMENT (22) Filed: Mar. 4, 2004 COMBINATION FOR ACNE TREATMENT AND PREVENTION Publication Classification (76) Inventor: Susan Thys-Jacobs, Larchmont, NY (51) Int. Cl.' ....................... A61 K 31/59; A61 K 31/525; (US) A61K 33/10; A61K 31/19 (52) U.S. Cl. ......................... 424/687; 514/168; 514/251; Correspondence Address: 514/574 GOTTLEB RACKMAN & REISMAN PC 27O MADSON AVENUE 8TH FLOOR (57) ABSTRACT NEW YORK, NY 100160601 A micronutrient Supplement comprising effective amounts (21) Appl. No.: 10/794,729 of calcium, Vitamin D, and folate treats and prevents acne. US 2005/0196469 A1 Sep. 8, 2005 MICRONUTRIENT SUPPLEMENT COMBINATION therapies include benzoyl peroxide which has comedolytic FOR ACNE TREATMENT AND PREVENTION and antibacterial effects, topical antibacterials Such as eryth romycin or clindamycin, azelaic acid, tazaroc, and topical FIELD OF THE INVENTION retinoids. Acne that is resistant to topical treatment requires oral antibiotics or isotretinoin. Indications for isotretinoin 0001. This invention relates to a micronutrient supple include Severe Scarring, acne that is resistant to oral antibi ment in the treatment of acne Vulgaris and inflammation. In otics and acne present for many years that quickly relapses particular, this invention relates to a multi-vitamin and when an oral antibiotic therapy is discontinued. Of note, oral mineral Supplement for improving skin and hair health. isotretinoin is a potent teratogen. Current Standards of acne therapy include the topical descquarnative drugs and antibac BACKGROUND OF THE INVENTION terial agents. In Women, anti-androgen therapy for acne 0002 Acne is a common problem affecting adolescents management has been relatively Successful and this may and young adults. It is the most common skin disease treated involve oral contraceptives, Spironolactone, and cyproter by physicians. Approximately 17-45 million people in the OC. US are afflicted with acne and although associated with the 0006 Very little is known concerning diet and acne. In very young, it can continue into well into adult life. It is fact, diet has never been shown to have much effect on often self-limited but can become chronic and result in acneiform eruptions although inadequate folate intake (less emotional distress and permanent Scarring. The reported than 400 micrograms daily) has been cited in one reference prevalence of acne varies from 35 to 90% of adolescents at to be associated with acne formation, (although the recom Some Stage. The prevalence of acne varies between Sexes mended quantity would not usefully treat acne) while excess and age groups, appearing earlier in females than in males, of the other B vitamins have erupted into acne. One citation possibly reflecting the earlier onset of puberty in females from Sheretz describes a Severe case of acneiform eruption with a greater Severity later in males as androgens levels that was temporally associated with high dose B6 and B12 rise. Acne occurs in up to 50% of adolescent girls and 85% Supplementation that resolved and promptly improved with of boys. Some Studies have shown a Seasonal variation in discontinuation of the vitamin complex. (Sheretz E. F. acne with an exacerbation during the colder months and an “Acneiform eruption due to vitamins B6 and B12', CUTIS improvement during the warmer months. 1991; 48(2): 119-20). Some vitamin deficiencies have been 0003) Acne is a disorder of the pilosebaceous follicles, asSociated with dermatitis and skin inflammation. An abnor sebaceous glands and rudimentary or vellus hair involving mal ratio of folate to B6 to B12 may have resulted in this the face, chest and back. The precise pathogenesis is not acne eruption and inflammation or merely the absence of known. Androgens have been linked to Stimulation of Sebum adequate folate ingestion. Acne formation, Sore tongue, production. Androgen Stimulates both Sebaceous gland cell cracking at the corners of the mouth have all been associated division and intracellular lipid Synthesis. Estradiol, on the with one or many deficiencies of the B vitamins Such as other hand, appears to have a potent inhibitory effect on riboflavin, folate, and pyridoxine. sebum production and little or no effect on cell division. 0007. The skin appears to be a very important source of Multiple complex factors have a role involving abnormal Vitamin D Synthesis and may even have a role in the keratinization, hormonal function, bacterial growth and catabolism of the B vitamin, folate. (B Cohn. “Sunlight, skin immune hyperSensitivity. These factors include increased color, and folic acid.” JAm Acad Dermatol. 2002; 46:31-8.) Sebum production, comedo formation, colonization of the Skin color may also pose a greater or lesser risk of either follicle by Propionibactrium and the host's inflammatory Vitamin D deficiency or folate photolysis based on pigment. response. Darker Skin has increased melanin with greater protection 0004. The primary acne lesion is the blackhead, an against ultraViolet radiation and skin cancer risk, but less of impaction and distension of the follicle with descquamated an ability to produce previtamin D from a give amount of keratinocytes and Sebum. Hormonal changes at puberty, ultraviolet radiation B (UVB). Lighter skin has the ability to Specifically androgens, can Stimulate the production of synthesize more vitamin D from UVB but has a greater risk Sebum and trigger acne lesions. Propionibacterium acnes is for skin cancer because of leSS melanin pigment. Branda and an anaerobic, gram positive bacterium that colonizes the Eaton in 1978 proposed that significant ultraviolet radiation piloSebaceous follicles following the increases in Sebum may result in chemical breakdown and photolysis of folate. production with the accompanying hormonal changes, (Branda R. F. “Skin Color and nutrient photolysis: an evo attracts polymorphonuclear neutrophils which release lutionary hypothesis. Science 1978; 201:625-6). Darker skin hydrolytic enzymes and contributes to the causation of acne. appears to protect against ultraViolet radiation induced folate Propionibacterium acnes also contributes to the inflamma photolysis. tory proceSS by hydrolyzing triglycerides to free fatty acids 0008 Vitamin and mineral preparations are commonly and by increasing follicular obstruction. Genetics appears to administered to treat Specific medical conditions or as gen have Some role in the Severity of acne. eral nutritional Supplements. Micronutrients are elements or 0005 Acne can develop into disfiguring scars or cysts as compounds which are present in foods in Small or trace inflammatory lesions resolve. Even Small inflammatory amounts and include Vitamins, minerals, or other elements. lesions may produce Scars. Acne treatment is a long term The macronutrients comprise carbohydrates, fats, and pro process that when abandoned, may result in the return of teins which Supply nutrients and calories. The primary acne Vulgneiform eruptions. To date, there has been no cure. Source of all nutrients is of course food. However, the However, there are numerous topical and oral treatments majority of people do not meet the Recommended Dietary that are effective in the management of acne. Current acne Allowance-RDA of the foods containing these essential treatment entails topical and Systemic preparations. Topical compounds and elements. Thus vitamin and mineral Supple US 2005/0196469 A1 Sep. 8, 2005 mentation has become a recognized method of meeting 40,000 IU daily (Vieth R). Attaining a 25 hydroxyvitamin D accepted medical and health Standards. concentration above 40 mg/ml may involve an intake of more than 2000 IU daily. 0009 Vitamin D is a fat soluble vitamin that is rarely 0010 Calcium has been shown to be particularly effec found naturally in food. It is not a true Vitamin, but is a tive in improving health. It is an essential mineral nutrient Steroid prohormone that is produced in the skin by ultravio that is necessary on a daily basis for numerous key physi let Sunlight and converted by a Series of hydroxylations to a ologic functions in the body, including nerve, muscle, skin, biologically active steroid hormone metabolite (M. Peacock. endocrine functions acting as an important Second messen “Effect of calcium and vitamin D insufficiency on the ger. Deficiencies of calcium can have broad ranging adverse skeleton. Osteoporosis Int. Suppl 8: S45-S51. (1998); Rein effects on many tissues and may manifest clinically as hold Vieth. “Vitamin D Supplementation, 25-hydroxyvita irritability, muscle Spasm, myalgias, fatigue, anxiety and min D concentrations and safety.” Am J Clin Nutrition, vol depression. Adequate dietary calcium intake has been shown 69, pp. 842-56. (1999). (herein Peacock M; Vieth R). to reduce bone resorption, osteoporosis and fracture risk. Vitamin D is a major regulator of calcium homeostasis and Chronic low dietary calcium intake results in low bone mass bone metabolism. However, only recently has it been in many animal investigations, while calcium Supplementa hypothesized that ingestion of adequate concentrations of tion leads to increased bone mass (Peacock M). Calcium is Vitamin D that maintain Vitamin D in the Sufficiency range required in Supporting the bone formation phase of bone can result in Superior bone health and vitality. There have remodeling and is essential in bone growth, in optimizing