IP Library Granted Patent US 12,440,432
Granted Patent B2
US 12,440,432 · App. 16/198,256 · Granted Oct 14, 2025

Methods and compositions for treatment of skin

Inventors: Burt R. Shaffer (Lloyd Harbor, NY); Steven M. Hernandez (Blue Point, NY)
Assignee: Topix Pharmaceuticals, Inc.
A61K8/365A61K8/06A61K8/42A61K9/0014A61K9/06A61K31/17A61K31/19A61K47/10A61K47/12A61K47/14A61K47/24A61P17/00A61Q19/007A61K9/127
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Quick Facts
Patent No.
US 12,440,432
App. No.
16/198,256
Granted
Oct 14, 2025
Kind
B2
Abstract

Disclosed are effective, non-irritating, skincare formulations containing an alpha hydroxy acid and urea or a urea derivative for topical application to the skin. The disclosed topical formulations provide enhanced penetration of the active ingredients to the skin for the treatment of amenable skin conditions, such as very dry skin and keratosis pilaris, as well as for improvement of aesthetic skin properties. Also provided are methods for therapeutic treatment of dermatological conditions by topically applying a formulation comprising (% w/w) at least 10% alpha hydroxy acid and at least 10% urea. The formulations may be cream emulsions, spray-ons, among other delivery systems.

Claims (69)

1. A topical formulation comprising (% w/w):

at least 15% alpha hydroxy acid (AHA), wherein the AHA comprises glycolic acid at least 10% urea or a urea derivative,

10.75%-30% potassium hydroxide, and

0.01%-5% hydrolyzed sodium hyaluronate, and

one or more of an exfoliating peptide, or a proteolytic enzyme,

an amino acid mixture, wherein the amino acid mixture consists of water, disodium EDTA, glycine, L-citrulline, L-alanine, L-proline, L-ornithine monohydrochloride, L-arginine, L-glutamic acid, L-histidine, valine, L-lysine, L-aspartic acid, leucine, threonine, tyrosine, DL-phenylalanine, taurine, L-isoleucine, methionine, and serine and wherein the amino acid mixture has a profile of the skin's natural moisturizing factor, and

one or more exfoliating agents comprising mandelic acid.

2. The formulation of claim 1 , wherein the glycolic acid is 15% w/w and the urea is 15% w/w.

3. The formulation of claim 1 , comprising 10% to 30% urea or a urea derivative.

4. The formulation of claim 1 , wherein the formulation has pH in the range of 3.5 to 7.0.

5. The formulation of claim 1 , further comprising one or more of an antioxidant, an emulsifier, a moisturizer, and an emollient.

6. The formulation of claim 1 , comprising (% w/w):

15%-40% AHA;

10%-40% urea or urea derivative;

10.75%-15% potassium hydroxide;

0.1%-5% hydrolyzed sodium hyaluronate;

0.1%-15% capric triglyceride;

0.1%-5% cetearyl glucoside;

0.1%-5% cetearyl alcohol;

0.1%-10% vitamin E acetate;

0.1%-10% glyceryl stearate;

0.1%-10% stearyl alcohol;

0.1%-5% PEG-100 stearate;

0.2%-15% emulsifying wax;

0.2%-2% phenoxyethanol;

0.2%-2% xanthan gum;

0.1%-10% squalane;

0.1%-10% dimethicone.

7. The formulation of claim 1 , comprising (% w/w):

15% glycolic acid;

15% urea;

10.75%-15% potassium hydroxide;

0.01%-1% hydrolyzed sodium hyaluronate;

0.5%-5% capric triglyceride;

0.2%-2% cetearyl glucoside;

0.2%-2% cetearyl alcohol;

0.5%-5% vitamin E acetate;

0.1%-4.5% glyceryl stearate;

0.2%-5% stearyl alcohol;

0.2%-2.5% PEG-100 stearate;

0.5%-7.5% emulsifying wax;

0.1%-1% phenoxyethanol;

0.05%-0.5% xanthan gum;

0.05%-5% squalane;

0.5%-5% dimethicone.

8. The formulation of claim 1 , further comprising a beta hydroxy acid (BHA), or ceramides.

9. A spray-on formulation comprising (% w/w):

at least 15% alpha hydroxy acid (AHA), wherein the AHA comprises glycolic acid, at least 10% urea or a urea derivative,

10.75%-30% potassium hydroxide, and

0.01%-5% hydrolyzed sodium hyaluronate, and

one or more of an exfoliating peptide, or a proteolytic enzyme,

an amino acid mixture, wherein the amino acid mixture consists of water, disodium EDTA, glycine, L-citrulline, L-alanine, L-proline, L-ornithine monohydrochloride, L-arginine, L-glutamic acid, L-histidine, valine, L-lysine, L-aspartic acid, leucine, threonine, tyrosine, DL-phenylalanine, taurine, L-isoleucine, methionine, and serine and wherein the amino acid mixture has a profile of the skin's natural moisturizing factor; and

one or more exfoliating agents comprising mandelic acid.

10. The spray-on formulation of claim 9 , further comprising one or more humectants.

11. The spray-on formulation of claim 9 , further comprising one or more emollients.

12. The spray-on formulation of claim 9 , further comprising skin lipid supplements.

13. The spray-on formulation of claim 9 , further comprising one or more antioxidants, wherein the one or more antioxidants comprises Camellia sinensis (Green Tea) polyphenols.

14. The formulation of claim 9 , further comprising a beta hydroxy acid (BHA), or ceramides.

15. A method for therapeutic treatment of a dermatological condition, comprising topically applying to an affected area a therapeutically effective amount of a formulation of claim 1 , thereby treating the dermatological condition.

16. The method of claim 15 , wherein the treating includes exfoliating affected skin.

17. The method of claim 15 , wherein the affected area is one or more of human skin, scalp, hair, nails.

18. The method of claim 15 , wherein the AHA is glycolic acid.

19. The method of claim 15 , wherein the formulation comprises 15% glycolic acid and 15% urea or a urea derivative.

20. The method of claim 15 , wherein the formulation comprises 10% to 30% urea or a urea derivative.

21. The method of claim 15 , wherein the formulation has pH in the range of 3.5 to 7.0.

22. The method of claim 15 , wherein the dermatological condition is keratosis pilaris.

23. The method of claim 15 , wherein the dermatological condition is very dry skin.

24. The method of claim 15 , wherein the formulation further comprises one or more of an exfoliating peptide, an amino acid having a natural moisturizing factor profile, a proteolytic enzyme, a keratolytic agent, a beta hydroxy acid (BHA), ceramides, sodium hyaluronate.

25. The method of claim 15 , wherein topically applying the formulation is pre-treatment for application of a topical agent for treatment of the dermatological condition.

Continuity (2)
Provisional Application 62589552 · Nov 21, 2017
Related Publication 20190151214A1 · May 23, 2019
References Cited (25)
US 3231472A · Engelmann · 1966 [cited by examiner]
US 5571503A · Mausner · 1996 [cited by examiner]
US 9168283B2 · Zheng · 2015 [cited by examiner]
US 9399009B1 · Clark et al. · 2016 [cited by applicant]
US 9492407B2 · Sundbom Nilsson et al. · 2016 [cited by applicant]
US 20060110415A1 · Gupta · 2006 [cited by examiner]
US 20070003486A1 · Jones · 2007 [cited by examiner]
US 20070248555A1 · Watson · 2007 [cited by examiner]
US 20100061946A1 · Scherner et al. · 2010 [cited by applicant]
US 20150283055A1 · Bonnet · 2015 [cited by examiner]
US 20160271033A1 · Kulesza · 2016 [cited by applicant]
RU 2038073C1 · 1995 [cited by applicant]
RU 2496476C1 · 2013 [cited by applicant]
RU 2622020C1 · 2017 [cited by applicant]
WO 9421216A1 · 1994 [cited by applicant]
WO WO03086291A2 · 2003 [cited by examiner]
WO 2011104562A1 · 2011 [cited by applicant]
WO WO2013092080A1 · 2013 [cited by examiner]
WO WO2014140524A1 · 2014 [cited by examiner]
Banchhor, Madhuri et al. Potentiality of Papain as an Antiaging Agent in cosmetic formulation. Pharmacognosy Reviews [Phcog Rev.] vol. 2, Issue 4, Jul.-Dec. 2008. p. 266-270. (Year: 2008). [cited by examiner]
International Search Report for corresponding International Patent Application No. PCT/US 2018/062320, mailed Mar. 14, 2019. [cited by applicant]
Written Opinion issued by the International Searching Authority for corresponding International Patent Application No. PCT/US2018/062320, mailed Mar. 14, 2019. [cited by applicant]
Sazykina et al. “URODERM, Combined Therapy for Excess Keratinization and Fungal Infections of the Skin and Nails”, Clinical Dermatology and Venerology, vol. 1, (2013), Edited by V.I. Nosdrin, pp. 1-6, Moscow. [cited by applicant]
European Search Report for EP18881031.1 dated Jun. 1, 2021, 6 pages. [cited by applicant]
Belousova T.A., “Passages, Uroderm”, Uroderm: (urea ointment 30%), 2015, pp. 6,18,21-23, ISBN 978-5-93118-038-0, XP009520668 with English machine translation. [cited by applicant]