USOO6203782B1 (12) United States Patent (10) Patent No.: US 6,203,782 B1 Eliaz et al. (45) Date of Patent: *Mar. 20, 2001 (54) METHOD AND PRODUCT FOR 2557 797 7/1985 (FR). PROMOTING HAIR GROWTH AND 2 671 721 7/1992 (FR). TREATING SKIN CONDITIONS 60-146829 8/1985 (JP). 2048 514 2/1990 (JP). (75) Inventors: Isaac G. Eliaz, San Rafael, CA (US); 3 176413 7/1991 (JP). Shmuel Gonen, Kiryat Ono (IL) OTHER PUBLICATIONS (73) Assignee: Universal Biologics, Inc., San Rafael, WPIDS abstract, AN 90-096011 (13), (JP 02048514 A), CA (US) Feb. 1990. WPIDS abstract, AN: 80-11414 c 07), Moreno, M. (FR (*) Notice: Subject to any disclaimer, the term of this 2424024), Dec. 28, 1979.* patent is extended or adjusted under 35 Susan Budavari, "The Merck Index', Merck & Co., Inc. U.S.C. 154(b) by 0 days. 1989, pp. 102, 107, 622. Hertel, Hermann, Seifen-Ole-Fette-Wachse, 107:313–314 This patent is Subject to a terminal dis (Jul 1981). claimer. Weiss, R. F., Arztezeitschrift fur Naturheilverfahren, 4:225-228 (Apr. 1982). Chemical Abstracts, 112(13): 115600u (1989). (21) Appl. No.: 08/645,767 Chemical Abstracts, 112(14):125228t (1989). (22) Filed: May 14, 1996 Chemical Abstracts, 115(6):57180f (1990). Related U.S. Application Data * cited by examiner Primary Examiner. Theodore J. Criares (63) Continuation-in-part of application No. 08/416,246, filed on (74) Attorney, Agent, or Firm- Piper Marbury Rudnick & Apr. 4, 1995, now abandoned, which is a continuation of application No. 08/106,804, filed on Aug. 16, 1993, now Pat. Wolfe, LLP; Steven B. Kelber No. 5,422,100, which is a continuation of application No. (57) ABSTRACT 07/659,959, filed on Feb. 25, 1991, now abandoned, which is a continuation-in-part of application No. 07/487,886, filed Methods and compositions for promoting hair growth, pre on Mar. 2, 1990, now abandoned. venting or minimizing hair loSS, enhancing or restoring hair (51) Int. Cl. ............................................. A61K 7/06 color or remelanization and treating other hair and skin (52) U.S. Cl. ......................... 424/70.1; 514/880; 514/852; conditions are disclosed. The methods include topical appli 424/74 cation of the compositions to the skin or hair follicles being (58) Field of Search ......................... 424/70.1, 74, 78.02, treated. The compositions include as an essential component 424/195.1, 514/852, 861, 863, 864, 880, a treatment agent in an amount effective for treating the 881 condition and Selected from the class of compounds con Sisting of anole, anethole, analogs thereof, polymers thereof (56) References Cited and mixtures thereof. Various combinations of these com pounds may be found in herb families including U.S. PATENT DOCUMENTS umbelliferae, magnoliaceae, labiatae and rutaceae. The 4,048,301 9/1977 Papantoniou ........................... 424/70 invention preferably contemplates Selecting the treatment 5,422,100 * 6/1995 Eliaz et al. ........................ 424/70.11 agent from the class of herbs consisting of Foeniculum vulgares (fennel seed), Pimpinella anisum (anise), Carum FOREIGN PATENT DOCUMENTS carvi (caraway Seeds) and mixtures thereof with each other 177920 4/1986 (EP). and/or other herbs. 308210 3/1989 (EP). 2 424 024 11/1979 (FR). 9 Claims, 2 Drawing Sheets U.S. Patent Mar. 20, 2001 Sheet 1 of 2 US 6,203,782 B1 47ZZ 60.0 50.0g % ERE : % OPLACEBO g 1. % 41 41 Fig.1 PERCENT TOTAL HAIR COUNTCHANGE 38 Ž% 120.0400 W LEGEND: OOO ZACTIVE : OPLACEBO 33g: %W 4 L-17y Fig.2 PERCENT TERMINAL (NONVELLUS) HAIR COUNT CHANGE 500 LEGEND: 390 e ACTIVE o PLACEBO TERMINAL 280 HAIR COUNT PERCENT CHANGE 70 60 -50 -50 O 50 OO 50 2OO 250 Fig 3 TOTAL HAIR COUNT-PERCENTCHANGE U.S. Patent Mar. 20, 2001 Sheet 2 of 2 US 6,203,782 B1 60 - 50 - 40 LEGEND: l ZACTIVE 30 OPLACEBO 2 20 7 O % O W Fig.O 4 TOTAL HAIR COUNTCHANGE 70 2 60 t 2 50 LEGEND: C ZACTIVE 40 OPLACEBO 177/7ZZY t 30 % 7A a E 2010 % O % DECREASE/ 31-00% NCREASE INCREASE <30% Fig.5 TER MINAL HAIR COUNT CHANGE US 6,203,782 B1 1 2 METHOD AND PRODUCT FOR percutaneous absorption preparation and a process for pre PROMOTING HAR GROWTH AND paring the product. U.S. Pat. No. 4,725,609 discloses a TREATING SKIN CONDITIONS topical nicotinamide composition for promoting angiogenesis, re-epithelialization and wound healing. U.S. RELATED APPLICATIONS Pat. No. 4,656,192 discloses tropolone esters as anti This is a continuation-in-part of application Ser. No. microbial agents, hair growth Stimulants and dental medi 08/416,246, filed Apr. 4, 1995, now abandoned, which is a CCS. continuation of application Ser. No. 08/106,804, filed Aug. JP-2048514 discloses a hair-growth promoting agent 16, 1993, now U.S. Pat. No. 5,422,100, issued Jun. 6, 1995, which contains a crude extract, an anionic Surfactant and a which is a continuation of application Ser. No. 07/659,959, Surfactant having nitrogen, and not being an anionic Surfac filed Feb. 25, 1991, now abandoned, which is a tant. continuation-in-part of application Ser. No. 07/487,886, JP-60-146829 discloses a testosterone 5-O-reductase filed Mar. 2, 1990, which is now abandoned. These appli inhibitor for use as an anti-androgen. The disclosed com cations and patent are incorporated herein by reference in positions contain an extract of a herb Selected from a list of their entirety. 15 26 ingredients, together with a Solvent. The composition is disclosed as a cosmetic for use as a hair tonic or Skin care. BACKGROUND OF THE INVENTION The Kosmetika Aerosole Riechstoffe discloses a variety 1. Field of the Invention of uses of herbal products. Fennel is mentioned for use in The present intention relates to methods and products for mouth and eye care and in bathing preparations. Hops, treating hair and skin conditions. Hair treatments include camomile, rosemary and yarrow are mentioned as having promoting hair growth in general and, in particular, promot applications including hair or Scalp care, or Shampoos. ing growth of hair transplants, preventing, Stopping or FR-2424024 discloses a composition for inhibiting hair minimizing hair loSS, reducing and/or preventing hair fallout loSS using a lotion of artemesia, parsley and 36-hour fer during chemotherapy, conditioning the hair and Scalp, thick 25 mented grapes brewed in a particular fashion requiring ening the hair, eyebrows and eyelashes, treating dandruff, maceration prior to filtration. Fennel and orange flower may etc. Treatments for Skin conditions include Smoothing of the be added to the mixing pot as optional ingredients. skin, treating Seborrheic dermatitis, treating cuticles, nails, In addition, various herbs have long been known in and nail fungus, treating psoriasis, healing of wounds in the chinese herbology or medicine as having various medicinal Skin, etc. or physiological applications. Various herbs have been dis 2. Discussion of the Background cussed as being effective for controlling the quality and color Treatments for hair loSS and other Scalp and hair disorders of hair as well being effective hair growth agents. In this addressed by the invention have long been Sought, and many connection, different herbs have been disclosed for treating treatments utilizing compositions based on extracts from pre-mature graying of hair. These herbs include: naturally-occurring herbs have been proposed. However, 35 1. He shou wu-Radix polygoni multiform; conclusive evidence of the efficacy of known compositions 2. Hei Zhi ma-Semen Sesami indici; and has been hard to find, and many of the reported or Suggested 3. Gougi Zi-Fructus lycii chinensis. results achieved with the prior art compositions lack Scien These herbs were used particularly in oral applications tific credibility. Such as in teas, but were Sometimes employed as local The present inventors, however, have discovered a com 40 external or topical applications. position which has been conclusively demonstrated to pro The following herbs have also been considered suitable duce a significant improvement in the conditions for which for treating baldness in local or topical applications: it is used as a treatment. Most unexpectedly, the composition has been found to be effective for treating hair loss in 1. Gu Sui bu-Rhizoma guSuibu (drynaria); Women, as well as in men. The present inventors have 45 2. Ce bai ye-Cacumen biotae orientalis. conducted Scientific Studies demonstrating the effectiveness Ce baiye, according to Chinese literature, when made in of the composition of the invention. a tincture from the fresh plant, has been tested and found to A number of treatment agents are disclosed in U.S. Pat. produce Sprouting of hair on bald people, reportedly in at No. 4,874,791 which describes a hair-growing agent con least thirteen cases. (Chinese Herbal Medicine, Material taining as an effective ingredient an aliphatic carboxylic acid 50 Medica-Bensky Gamble, page 370.) having an odd number of carbon atoms or a derivative Prior art attempts to produce a hair growth promotor have thereof. investigated a large number of compounds as candidates but U.S. Pat. No. 4,814,351 discloses yet another scalp treat have generally considered factorS Such as a particular mix ment for reducing average daily hair loSS by periodically ture of Surfactants or a specific process to be essential. The applying to the Scalp a composition containing an active 55 near-alchemical requirements of the prior art for Special chelating agent. The background discussion of this reference process features and the long lists of potential ingredients, Sets forth various theories for enhancement or restoration of coupled with failure to provide conclusive Scientifically hair color to its natural or pre-gray color or, in other words, proven results clearly indicates that prior art compositions remelanization of the hair.