United States Patent (19) 11 Patent Number: 6,099,870 Cauwenbergh (45) Date of Patent: *Aug
Total Page：16
File Type：pdf, Size：1020Kb
US00609.987OA United States Patent (19) 11 Patent Number: 6,099,870 Cauwenbergh (45) Date of Patent: *Aug. 8, 2000 54 METHODS FOR IMPROVING THE HEALTH Bergfeld, F.W., “Hair Disorders' Dermatology 1541-1560 OF HAIR AND SCALP (1992). 75 Inventor: Gerard F. Cauwenbergh, Plainsboro, Pierard-Franchimont, C., et al., Approche Physio pathologique de la Seborrhee Du Cuir Chevelu:, 115 Ann. Dermatol. Venereol. 451-53 (1988). “Pierard”). 73 Assignee: Johnson & Johnson Consumer Companies, Inc., Skillman, N.J. English abstract-Van Vloten. English abstract-Pierard. * Notice: This patent issued on a continued pros ecution application filed under 37 CFR English abstract-Sabouraud. 1.53(d), and is subject to the twenty year patent term provisions of 35 U.S.C. Dawber, P., “The Scaly and Itchy Scalp", Hair and Scalp 154(a)(2). Disorders 191-227 (1995). Ford, G.P., et al., 111 Br. J. Dermatol 603–07 (1984) 21 Appl. No.: 09/208,948 (“Ford”). 22 Filed: Dec. 9, 1998 Sabouraud, R., “Maladies Due Cuir Chevelu II'', Les Mala Related U.S. Application Data dies Desquamatives, 207-327 (1904) “Sabouraud"). 60 Provisional application No. 60/069,993, Dec. 18, 1997. Van Vloten, W., et al., “Eczeem’, 8 Dermatologie and 51 Int. Cl." .......................... A61K 33/04; A61K 33/00; Venerologie 90–109 (1966) “Van Vloten”). A61K 31/555; A61K 31/415 Arrese, J., et al., “Effect of Ketoconazole Medicated Sham 52 U.S. Cl. .......................... 424/702; 424/722; 514/188; poos on Squamometry and MalaSSezia Ovalis Load in 514/399 Pityriasis Capitis”, 58 Cutis 235-37 (1996). 58 Field of Search ..................................... 424/702, 722; Shuster, S., “Psoriatic Alopecia”, 87 Br. J. Dermatol. 74–77 514/188,399 (1972). 56) References Cited U.S. PATENT DOCUMENTS Primary Examiner Raymond Henley, III Attorney, Agent, or Firm Michele G. Mangini 4.942,162 7/1990 Rosenberg et al.. 5,270,035 12/1993 Chimento .................................. 424/70 57 ABSTRACT 5,456.851 10/1995 Liu et al.. 5,639,459 6/1997 Bouras ................................. 424/195.1 A method of increasing the amount of anagen hair in a 5,650,145 7/1997 Saint-Leger ...... ... 424/70.1 human comprising applying an azole or Zinc pyrithione, or 5,702,691 12/1997 Ichinose et al. ... 424/70.1 mixtures thereof to an area of a human where an increase in 5,760,043 6/1998 Dufetel et al. .......................... 514/272 the amount of anagen hair is desired. Also provided is a FOREIGN PATENT DOCUMENTS method of reducing the Shedding of hair in a human com prised of applying an effective amount of an azole or Zinc 1295276 11/1972 United Kingdom. pyrithione to an area of a human where Such a reduction is WO 9629045 9/1996 WIPO. desired. Further provided is a method of increasing the WO 9629983 10/1996 WIPO. diameter of a hair shaft comprising topically applying an OTHER PUBLICATIONS effective amount of an azole to an area of a human where an Rushton, D.H., et al., “Natural Progression of Male Pattern increase in the diameter is desired. Baldness in Young Men”, 16 Clin. Exp. Dermatol. 188-192 (1991). 41 Claims, 4 Drawing Sheets U.S. Patent Aug. 8, 2000 Sheet 3 of 4 6,099,870 FIG 3 KETOCONAZOLE GROUP-SEBUM EXCRETION RATES 120 START VERSUS 6 MONTHS SCATTERGRAM 100 80 SEEBUM EXCRETION RATEVALUES 60 AT6 MONTHS 40 20 O 20 40 60 80 00 20 SEBUM EXCRETION RATE VALUESAT START FIG 3 ZINC PYRITHONE GROUP-SEBUM EXCRETION RATES START VERSUS 6 MONTHS SCATTERGRAM 120 100 80 SEEUM EXCRETION RATE VALUES 60 AT6 MONTHS 40 20 O 20 40 60 30 OO 120 SEBUM EXCRETION RATE VALUESAT START 6,099,870 1 2 METHODS FOR IMPROVING THE HEALTH Male Pattern Baldness in Young Men,” 16 Clin. Exp. OF HAIR AND SCALP Dermatol. 188-192 (1991); Bergfeld, F. W., “Hair Disor ders’ Dermatology 1541-1560 (1992); and Pierard CROSS-REFERENCE TO RELATED Franchimont, C., et al., “Approche Physiopathologique de la APPLICATION Seborrhee Du Cuir Chevelu, 115 Ann. Dermatol. Venereol. This Application claims the benefit of U.S. Provisional 451–53 (1988). Application No. 60/069,993 filed on Dec. 18, 1997, which is Various methods have been employed to stimulate the incorporated by reference in its entirety. growth of hair and/or increase its diameter; however, these methods are not without their shortcomings. One known method employs the application of minoxidil to areas Such BACKGROUND OF THE INVENTION as the Scalp for purposes for Stimulating hair growth and 1. Field of the Invention prolonging the period of time that hair is in the anagen The present invention relates to methods of improving the phase. Unfortunately, this method has been found to be health of hair and the Scalp. More particularly, this invention effective in only a Small proportion of users. Another known relates to methods for reducing hair Shedding, methods for 15 method for increasing hair diameter involves the application increasing hair diameter, and methods for maintaining hair of Silicone-containing treatments to areas Such as the Scalp. in the anagen phase for a prolonged period of time. Disadvantageously, this method produces a “build-up' of 2. Description of Prior Art Silicone on the hair that tends to dull its physical appearance. Dandruff ("pityriasis capitis sicca') and seborrheic der It would be desirable to provide a method of treating matitis ("pityriasis capitis oleosa) are two related clinical Seborrhigic dermatitis and dandruff by improving these manifestations of one common dermatological disorder that alternative manifestations indicative of an unhealthy Scalp. involves the Scalp as well as other areas of the body having SUMMARY OF THE INVENTION a high density of sebaceous glands. While dandruff is In accordance with this invention, there is provided a primarily a Scaling condition, it is often also associated with 25 Some inflammation. See e.g. Dawber, P., “The Scaly and method of increasing the amount of anagen hair in a human Itchy Scalp." Hair and Scalp Disorders 191-227 (1995). comprising, consisting essentially of, and/or consisting of Typically dandruff is expressed on the Scalp, but other areas applying an effective amount of an agent which inhibits the of the body that are predisposed to Seborrheic dermatitis also growth of P. Ovale or a mixture thereof to an area of a human often show mild Scaling without obvious signs of inflam where an increase in the amount of anagen hair is desired. mation. In Seborrheic dermatitis, the inflammatory counter In another embodiment of this invention, there is provided part of the same disorder, erythema is always present, and a method of reducing the Shedding of hair in a human the inflammatory infiltrate is more pronounced. See e.g. comprising, consisting essentially of, and/or consisting of Ford, G. P., et al., 111 Br. J. Dermatol 603–07 (1984) topically applying an effective amount of an agent which (“Ford”). 35 inhibits the growth of Povale or a mixture thereof to an area Those of skill in the art have come to the consensus that of the human where a decrease in the Shedding is desired. both dandruff and seborrheic dermatitis are two aspects of In yet another embodiment of this invention, there is the same disease. See Ford; Sabouraud, R., “Maladies Due provided a method of increasing the diameter of a hair shaft Cuir Chevelu II, Les Maladies Desquamatives, 207-327 comprising, consisting essentially of, and/or consisting of (1904); and Van Vloten, W., et al., “Eczeem,” 8 Dermatolo 40 topically applying an effective amount of an imidazole, a gie and Venereologie 90-109 (1996). It is well known that triazole, Selenium Sulfide, a lithium-containing product, or individuals who have dandruff will, if the condition is not mixtures thereof to an area of a human wherein an increase treated, often develop the more inflammatory aspect in the diameter is desired. Seborrheic dermatitis, while those having Seborrheic derma The methods of this invention not only are effective in titis might show Scaling only during the periods of leSS 45 alleviating Symptoms indicative of unhealthy hair and Scalp, pronounced inflammation. Although those skilled in the art but also are effective in treating two underlying, related generally agree that the lipophylic yeast, Pityrosporum Ovale clinical manifestations, dandruff and Seborrheic dermatitis. (“P ovale”), is a key contributor in the pathogenesis of BRIEF DESCRIPTION OF THE DRAWINGS Seborrheic dermatitis and dandruff, it is likewise accepted that both conditions should not be regarded as an infection. 50 The invention will be more fully understood and further Rather, it is the yeast's Overcolonization of the Scalp and advantages will be come apparent when reference is made to other body areas having a high density of Sebaceous glands the following detailed description of the invention and the that causes a very mild inflammatory reaction, i.e. dandruff, accompanying drawings in which: or a moderate inflammatory reaction, i.e. Seborrheic FIG. 1 is a graph of the percent change in amount of dermatitis, redness, as well as an accelerated turnover of the 55 anagen hair from baseline in a 6 month period versus the epidermis. See Ford and Arese, J., et al., “Effect of Keto amount of panelists. conazole Medicated Shampoos on Squamometry and FIG. 2 is a graph of the percent change in hair diameter Malassezia Ovalis Load in Pityriasis Capitis,” 58 Cutis from baseline in a 6 month period versus the amount of 235–37 (1996). panelists. Typical primary Symptoms of dandruff and Seborrheic 60 FIG. 3 is a scattergram of the baseline sebum excretion dermatitis include Scaling, redness, and itching; however, rate (ug/cm/hr) versus the sebum excretion rate (ug/cm/hr) Several other clinical manifestations Such as Seborrhea Six months later for Subjects using a ketoconazole (oiliness), telogen effluvium (shedding), thin Shaft diameter, containing shampoo (FIG.