Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Ester doai
Reexamination Certificate
1996-02-29
2001-02-13
Moezie, Minna (Department: 1617)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Ester doai
C514S275000, C514S356000
Reexamination Certificate
active
06187815
ABSTRACT:
FIELD OF THE INVENTION
The present invention is directed to methods and compositions for promoting the activity of the hair follicles of a living organism and, in particular, to compositions, medicaments, and methods for the treatment of the hair follicles of a human scalp to promote the growth of hair thereon.
BACKGROUND OF THE INVENTION
At birth, the average human scalp has approximately 100,000-150,000 hair follicles. Initially, hair follicles normally exhibit fine lanugo hair shafts, which are commonly referred to as “baby hair”. This lanugo hair “matures” eventually, into terminal hair shafts, which is the hair most often exhibited during adolescence and adulthood. Thereafter, this terminal hair may remain as such, or it may develop into non-terminal vellus hair, which is commonly referred to as a “thinning” of the hair and, in more advanced stages, baldness.
The precise mechanism that triggers the development of non-terminal vellus hair is not precisely understood or agreed upon. However, there have been numerous attempts to provide an effective safe prophylaxis to arrest development of non-terminal vellus hairs and even to stimulate the regeneration of these vellus hairs into terminal hair shafts. Unfortunately, none of these attempts have proven to be fully satisfactory.
Thus, it can be seen that there remains a need for compositions, medicaments, and methods for administering the same, which are effective in stimulating the development of terminal hairs from non-terminal vellus hairs, are safe for use with a human host, and which are easy to administer.
There are many causes of hair loss for which suitable treatments are well known. For example, if the hair loss is due to general poor health of the patient, then a program designed to improve overall health would be instituted. If the patient's dietary habits are the cause of hair loss, then the patient's diet should be changed. If the patient's medications have the side effect of hair loss, then the medications should possible be changed. If a patient's shampoo is the cause of the hair loss, then the shampoo should be changed. If the patient's hair loss can be attributed to certain types of stress, then those types of stress should be eliminated or reduced. A patient's hair loss may be attributable to certain underlying dermatological conditions such as psoriasis, seborrheic dermatitis, perifolliculitis capitis, pseudopelade of Brocq (alopecia cicatricata), lichenplanopilaris, fungal and bacterial infections, connective tissue diseases such as lupus erythematosus, scleroderma, sarcoidosis, genetic abnormalities (including ectodermal dysplasia) among others.
A patient's hair loss may be attributable to certain underlying symptomatic conditions or drug exposure, such as telogen effluvium and anagen effluvium. The compositions and methods of the invention may be employed to supplement or augment known treatments for such conditions.
Telogen effluvium is hair loss that often results in three to six months after a serious illness such as pneumonia, a life-threatening illness, a surgical intervention, or other illness that requires a person to spend an unusually large amount of time in bed rest. Telogen effluvium generally self corrects from three to six months after its onset.
Anagen effluvium is hair loss that results when patients are administered chemotherapeutic agents, or other toxic agents. It is theorized that anagen effluvium is caused by a sudden shock to hair generating tissues (hair bulbs) in the growing state that can result from the administration of chemotherapeutic agents. As a result of the shock, the growing hairs fall out of the hair follicles.
If the patient's hair loss is due to hypothyroidism, then increased thyroid hormones can be administered. If perceived hair loss is due to hyperthyroidism, then the patient's thyroid activity can be reduced by drug therapy. It is noted that hypothyroidism diminishes the amount of hair that will grow because of decreased metabolic rates. Hyperthyroidism causes hairs to become very fine, and the very fine hairs are perceived to be hair loss.
To determine specific known causes of hair loss, a history is taken, and a physical examination is conducted. Once a known cause of hair loss is diagnosed for which a known treatment is accepted, then the known treatment can be instituted.
However, even with types of hair loss whose cause is determined and whose treatment is known, the rate of return of the lost hair may often be undesirably slow. It would be desirable, therefore, to be able to treat the patient being treated for a known cause of hair loss to accelerate the return of hair to such patients.
There are other types of hair loss for which the causes are less well understood, and only a few and limited known effective treatments are accepted in medical practice, i.e., the use of topical minoxidil. For these types of hair loss, the need for alternate effective treatments is very strong. Some examples of hair loss for which satisfactory treatments are not currently available include: male androgenetic alopecia and female androgenetic alopecia (male and female pattern baldness).
Another form of alopecia, known as alopecia areata (including alopecia totalis and alopecia universalis), is a type of hair loss for which no single or multiple treatment modalities (even including minoxidil) are considered to be highly effective.
As further background, it is noted that some vasodilators have been tried topically to treat hair loss, and these vasodilators have not been effective. For example, diazoxide has been tried topically on the scalp to promote hair growth, but this was not deemed to be effective.
It would be desirable to provide effective topical treatments of the hair loss conditions for which satisfactory topical treatments are not currently available.
A number of patents and publications have been uncovered which may be relevant to the scalp treatment methods and compositions of the invention set forth hereinbelow. These patents and publication are as follows, in approximate chronological order:
1. French patent No. 336,814 of Ascoli (1904)
2. New York State Journal of Medicine, Vol. 49, (1949), pages 1317-1318
3. Aslan A: Med. Klin.: 52, 1758, 1759, 1760 (1957)
4. Scholzel, P.: Med. Klin.: 53, 2239 (1958)
5. French patent No. 1439833 of Serviere (1966)
6. U.S. Pat. No. 3,644,364 of Anthony (1972)
7. Chemical Abstracts No. 79:23508s (1973)
8. French patent No. 72.39675 of Indaly Oy (1973)
9. UK patent No. 1 354 446 of Indal Oy (1974)
10. U.S. Pat. No. 3,896,238 of Smith (1975)
11. U.S. Pat. No. 3,903,256 of MacMillan et al (1975)
12. U.S. Pat. No. 3,952,099 of Smith (1976)
13
. Merck Index of Chemicals and Drugs
, hereinafter “Merck”, 9th Edition, Merck & Co., Rahway, N.J., (1976), entries 6340 and 6343.
14. U.S. Pat. No. 4,139,619 of Chidsey (1979)
15. U.S. Pat. No. 4,150,114 of Smith (1979)
16. UK patent no. 1 603 639 of Haggar (1981)
17. Chemical Abstracts No. 96:74505x (1981)
18
. Current Therapy
, (1981), page 662
19. U.S. Pat. No. 4,329,338 of Szego et al (1982)
20. Japanese application no. 58-103310 of Yoshiya (1983)
21. Conn's
Current Therapy,
1984, entry on “Alopecia”, by Gonzalez et al, pages 599-603.
22. Chemical Abstracts No. 104:24067u (1985)
23. EPO Patent No. 0 158 090 of Roshdy (1985)
24. U.S. Pat. No. 4,596,812 of Chidsey et al (1986)
25. EPO application No. 0 188 793 of Gans et al (1986)
26. UK patent application No. 2 176 104A of Grollier (1986)
27. UK patent application No. 2 177 919A of Salim (1987)
More specifically, with respect to the references listed above, the following summaries of their disclosures are provided.
1. French patent No. 336,814 of Ascoli (1904) appears to disclose a composition used to promote hair growth. The composition appears to disclose the active ingredient to be the chlorhydrate of cocaine. The carrier appears to be a grease, such as vaseline, to form a pomade.
2. New York State Journal of Medicine, Vol. 49, (1949), pages 1317-1318, discloses a solution of niacin and pro
Hallam Kenneth M.
Robinson Howard N.
Bloom Leonard
Moezie Minna
Wang S.
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