Loma Psoriasis
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An Effective Remedy for Psoriasis

LOMALUX PSORIASIS

MECHANISM OF ACTION

DESCRIPTION:

LOMALUX PSORIASIS is a natural mineral medication indicated for the treatment of psoriasis. The major constituents are inorganic nickel and inorganic bromide. Each teaspoon contains about 1.1 mg nickel and 23.4 mg bromide. Active ingredients: potassium bromide 3.5 mg/ml, sodium bromide 3.0 mg/ml, nickel sulphate 0.6 mg/ml, zinc bromide 0.004 mg/ml, potassium sulphate 0.025 mcg/ml. Inactive ingredients: purified water, less than 3% ethyl alcohol, 0.15% methyl paraben and 0.03% propyl paraben.

CLINICAL PHARMACOLOGY:

The active ingredients in LOMALUX PSORIASIS are inorganic soluble nickel and bromide salts. The exact mechanism of action of LOMALUX PSORIASIS is unknown; however, it is felt to be helping the body compensate for a primary genetic biochemical defect. This biochemical defect is felt to be a nickel-dependent metalloenzyme system which is made more efficient in a nickel enriched environment¹. Bromide has known antiproliferative properties and may also exert an antipruritic effect.

Nickel sulfate dissolves and dissociates in the digestive tract into its ionic constituents. Nickel associates with albumin and other constituents in the blood stream². Variable amounts of ionic nickel, 15% to 50%, are absorbed on a fasted stomach². Clinical studies show that serum concentrations of nickel are variable among patients receiving the same dosage.³ Additionally, food markedly decreases the rate and extent of nickel absorption.^4,5 Peak serum nickel concentration is reached about two hours after oral administration. Once a day dosing leads to steady state serum concentrations in approximately seven days. Nickel is in its highly stable divalent cation state and is therefore not expected to be metabolized to any significant degree in the body. Absorbed nickel is primarily excreted in the urine and elimination half-life is about 21 hours.^3,4 Renal clearance is rapid and efficient, and nickel does not accumulate in the body.⁶ Sodium bromide and potassium bromide dissolves and dissociates in the digestive tract into its ionic constituents. Ionic bromide is rapidly and completely absorbed from the intestine and distributed almost exclusively in the extracellular fluids.^7,8 Bromide is eliminated by the kidney and the elimination half-life is 11- 12 days. Once a day dosing will lead to a steady state concentration in about seven weeks.⁷

Clinic studies of 86 psoriasis subjects given oral doses of nickel sulfate and sodium bromide, two principal ingredients of LOMALUX PSORIASIS, indicate a high degree of statistical significance (p<0.0001) in the improvement in psoriasis area and severity measurements (PASI score)⁹. Ninety-eight percent of subjects exhibited a moderate to marked improvement (0-25%PASI=mild improvement; 25-75%PASI=moderate improvement; 75-100%PASI=marked improvement). A double blind placebo controlled study confirmed safety and efficacy, employing nickel and bromide from a nickel bromide source.¹⁰

INDICATIONS:

LOMALUX PSORIASIS is indicated for the treatment of psoriasis vulgaris, including skin, nail and joint symptoms. Other types of psoriasis also respond, including hand/foot psoriasis, inverse psoriasis, and pustular and exfoliative types. Scalp, facial and genital psoriasis respond particularly well.

1. Smith, SA. Elevated serum nickel concentration in psoriasis vulgarism Int J Dermatology 1994; 33(11):783-785.
2. Sunderman FW Jr. Biological monitoring of nickel in humans. Scand J Work Environ Health 1993;1 9 suppl 1:34-38.
3. Christensen OB, Lagesson V. Nickel concentration of blood and urine after oral administration. Annals of Clinical and Laboratory Science 1981;2(2):119-125.
4. Sundennan FW Jr., Hopfer SM, Sweeney KR, Marcus AH, Most BM, Creason J. Nickel absorption and kinetics in human volunteers. P.S.E.B.M. 1989;191:5-11.
5. Solomons NW, Viteri F, Shuler TR, Nielsen FH. Bioavailability of nickel in man: Effects of foods and chemically-defined dietary constituents on the absorption of inorganic nickel. J Nutr 1982; I 12:39-50.
6. Nielsen FH. Is nickel nutritionally important? Nutrition Today 1993;28(l):14-19.
7. Vaiseman N, Koren G, Pencharz P. Pharmacokinetics of oral and intravenous bromide in normal volunteers. Clinical Toxicology 1986;24(5):403-413.
8. van Leeuwen FXR, Sangster B. The toxicology of bromide ion. CRC Critical Reviews in Toxicology 1987; 18(3):189-213.
9. Smith SA. Oral supplementation of nickel and bromide in psoriasis vulgaris using nickel sulfate and sodium bromide. 1995 (unpublished report).
10. Smith SA. Improvement of psoriasis vulgaris with oral nickel dibromide. Archives of Dermatology 1997; 133:661-663.

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