Hair regeneration compositions for treatment of alopecia and methods of application related thereto

• US 6,030,948 A
• Filed: 12/19/1997
• Issued: 02/29/2000
• Est. Priority Date: 12/19/1997
• Status: Expired due to Fees

• Current Assignee: RegeneRx Biopharmaceuticals, Inc.
• Original Assignee: Morris A. Mann
• Inventors: Mann, Morris A.
• Primary Examiner(s): Cook, Rebecca
• Application Number:
  US08/994,347
• Time in Patent Office: 802 Days
• Field of Search: 514/12
• US Class Current: 514/9.7
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 8/41 Amines
• CPC Class Codes: A61K 8/492 having condensed rings, e.g. indol
• CPC Class Codes: A61K 8/4946 Imidazoles or their condensed derivatives, e.g. benzimidazoles
• CPC Class Codes: A61K 8/498 having 6-membered rings or their condensed derivatives, e.g. coumarin
• CPC Class Codes: A61K 8/63 Steroids; Derivatives thereof
• CPC Class Codes: A61K 8/64 Proteins; Peptides; Derivatives or degradation products thereof
• CPC Class Codes: A61P 17/14 for baldness or alopecia
• CPC Class Codes: A61Q 7/00 Preparations for affecting hair growth

Abstract

Hair regeneration compositions containing Tα1, Tβ4, or a combination thereof for treating alopecia on the scalp of a patient in need thereof are disclosed. Teatment methods include (1) cleansing the scalp with a cleansing agent; (2) treating the cleansed scalp with a keratin solvent system; (3) applying a topical anesthetic (optional); (4) applying an acid peel solution; (5) applying a hyperactive urea gel formula (optional) and (6) applying a hair regeneration composition.

Claims

1. A hair regeneration composition comprising a thymic extract in an amount ranging from 0.1 to 10 percent by weight wherein the thymic extract is thymosin α

1 or thymosin β

4 or a combination thereof and at least one component which is selected from the group consisting of a steroid;

an indole-based compound selected from the group consisting of indole, melatonin, N-[2-(5-Methoxy-1H-indol-3-yl)ethyl]acetamide, skatole and indole-3-carbinol;

a mitocide;

a bioflavanoid;

an antiffungal compound selected from the group consisting of undecylenic acid, griseofulvin, terbinafine and an azole compound; and

an anti-inflammatory fatty acid.

2. The composition of claim 1 wherein the thymic extract is thymosin fraction 5 (TF5).

3. The composition of claim 1 wherein the steroid is progesterone, pregnenolone, spironolactone, dehydroepiandrosterone (DHEA), or testolactone.

4. The composition of claim 1 wherein the mitocide is a solution of surfactant, fragrance and skin penetrant.

5. The composition of claim 4 wherein the fragrance is menthol, benzyl alcohol, eugenol, phenoxyethanol, isopropyl palmitate, isopropyl myristate, benzyl salicylate, phenylethyl salicylate, thymol, isoamyl salicylate, phenylethyl salicylate, benzoic acid, benzyl benzoate, methyl salicylate, phenol, oleic acid, caproic acid or carbaryl.

6. The composition of claim 1 wherein the bioflavanoid is querretin methyl chalcone.

7. The composition of claim 1 wherein the azole compound is ketoconazole or fluconazole.

8. A method for treating alopecia on the scalp of a patient in need thereof, comprising the steps of:

cleansing the scalp with a cleansing agent;

treating the cleansed scalp with a keratin solvent system;

applying an acid peel solution to the keratin treated scalp; and

applying a hair regeneration composition to the acid-peeled scalp, wherein the hair regeneration composition comprises a thymic extract in an amount ranging from 0.1 to 10 percent by weight, wherein the thymic extract is thymosin α

1, thymosin β

4 or a combination thereof.

9. The method of claim 8 wherein the hair regeneration composition further comprises at least one component which is selected from the group consisting of a steroid;

an indole compound selected from the group consisting of indole, melatonin, N-[2-(5-Methoxy-1H-indol-3-yl)ethyl]acetamide, skatole and indole-3-carbinol;

a mitocide;

a bioflavanoid;

an anti-fungal compound selected from the group consisting of undecylenic acid, griseofulvin, terbinafine and an azole compound; and

an anti-inflammatory fatty acid.

10. The method of claim 8 wherein the cleansing agent is a cleansing shampoo.

11. The method of claim 10 wherein the cleansing shampoo is a hard-surface ethoxylated cleanser.

12. The method of claim 8 wherein the keratin solvent system is an acetic acid-based formula or a urea-based gel formula.

13. The method of claim 12 wherein the urea-based gel formula comprises at least one of the following:

urea, citric acid, urea-peroxide, propylene glycol, ethoxylated alcohols or acrylic acid copolymer.

14. The method of claim 8 further comprising the step of applying a topical anesthetic prior to application of the acid peel solution.

15. The method of claim 14 wherein the topical anesthetic is a fragrance.

16. The method of claim 14 wherein the hair regeneration composition further comprises a surfactant or a solubilization agent.

17. The method of claim 8 wherein the acid peel solution comprises at least one physiological acid.

18. The method of claim 17 wherein the physiological acid is citric acid, ascorbic acid or pyruvic acid.

19. The method of claim 8 wherein the acid peel solution is allowed to remain on the scalp for about 1 minute.

20. The method of claim 8 wherein the acid peel solution is allowed to remain on the scalp for about 1 hour and an occlusive cap is placed over the scalp.

21. The method of claim 8 wherein the acid peel solution is allowed to remain on the scalp for up to about 8 hours and an occlusive cap is placed on head covering the scalp.

22. The method of claim 8, further comprising the step of applying a hyperactive urea gel formulation to solubilize bumps present on the surface of the scalp prior to application of the hair regeneration composition.

23. The method of claim 22 wherein the hyperactive urea gel formulation is at least one of the following:

urea, citric acid, urea-peroxide, 2-phenoxyethanol, propylene glycol, or ethoxydiglycol.

24. The method of claim 9 wherein the steroid is progesterone, pregnenolone, spironolactone, dehydroepiandrosterone (DHEA), or testolactone.

25. The method of claim 9 wherein the mitocide is a solution of surfactant, fragrance and skin penetrant.

26. The method of claim 25 wherein the fragrance is menthol, benzyl alcohol, eugenol, phenoxyethanol, isopropyl palmitate, isopropyl myristate, benzyl salicylate, phenylethyl salicylate, thymol, isoamyl salicylate, phenylethyl salicylate, benzoic acid, benzyl benzoate, methyl salicylate, phenol, oleic acid, caproic acid or carbaryl.

27. The method of claim 9 wherein the bioflavanoid is querretin methyl chalcone.

28. The method of claim 9 wherein the azole compound is ketoconazole or fluconazole.