# US 2025/0375474 A1 · Compositions for the prevention and treatment of moisture-associated skin damage

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- Number: US 2025/0375474 A1
- Document ID: US20250375474A1
- Status: Published application
- Kind: A1
- Application number: 18/875,919
- Filed: 2023-06-21
- Published: 2025-12-11
- Earliest claimed: 2022-06-22
- Assignees: Johanna MERCER; Scotiaderm Inc.
- Applicants: Scotiaderm Inc.
- Inventors: Ann GORDON
- Web page: https://patentgrep.com/patent/US20250375474A1

## CPC

- A61K 33/30: Zinc; Compounds thereof
- A61K 9/0014: {Skin, i.e. galenical aspects of topical compositions (non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00)}
- A61K 9/06: Ointments; Bases therefor; {Other semi-solid forms, e.g. creams, sticks, gels (composition of ointments, creams or gels A61K47/00)}
- A61K 31/4174: Arylalkylimidazoles, e.g. oxymetazolin, naphazoline, miconazole
- A61K 31/573: substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
- A61K 31/695: Silicon compounds
- A61K 47/02: Inorganic compounds
- A61K 47/06: Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 47/183: {Amino acids, e.g. glycine, EDTA or aspartame}
- A61K 47/36: Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K 47/44: Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin (synthetic glycerides, e.g. medium-chain triglycerides, A61K47/14)
- A61P 17/16: Emollients or protectives, e.g. against radiation
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

Therapeutic compositions, kits, and methods and uses thereof are provided. The compositions comprise zinc oxide, hydrocortisone, and/or clotrimazole.

## Claims

### Claim 1

A therapeutic composition comprising:
from about 10% to about 15% by weight zinc oxide;
1% by weight hydrocortisone;
from about 0.5% to about 1% by weight clotrimazole;
optionally from about 40% to 50% by weight petrolatum;
optionally from about 0.01% to about 2.5% by weight dimethicone; and
optionally about 0.1-30% by weight a proteolytic enzyme inhibitor, preferably the proteolytic enzyme inhibitor is a trypsin inhibitor.

### Claim at position 2

-17. (canceled)

### Claim 18 (depends on 1)

The therapeutic composition of claim 1, wherein the composition comprises the proteolytic enzyme inhibitor, wherein the proteolytic enzyme inhibitor comprises Soybean Trypsin Inhibitor (STI), Birk-Bowman Inhibitor (BBI), non-denatured soybean extract, or a combination thereof.

### Claim 19

(canceled)

### Claim 20 (depends on 1)

The therapeutic composition of claim 1, comprising:
a) one or more non-active ingredients selected from the group consisting of cetearyl alcohol, mineral oil, lanolin, paraffin, water, sodium phosphate, EDTA, modified corn starch, and chlorocresol; and/or
b) one or more additives, and wherein the additives are pH buffers, humectants, antimicrobial agents, antifungal agents, or peptides.

### Claim 21 (depends on 1)

The therapeutic composition of claim 1, comprising:
a)
12.5% by weight zinc oxide;
1% by weight hydrocortisone;
0.5% by weight clotrimazole;
0.05% by weight dimethicone; and
85.95% by weight petrolatum;
b)
15% by weight zinc oxide;
1% by weight hydrocortisone; and
1% by weight clotrimazole;
or c)
45% by weight petrolatum;
4% by weight cetearyl alcohol and ceteareth-20;
11% by weight mineral oil;
2% by weight lanolin;
4.5% by weight parafin;
10% by weight water;
0.2% by weight sodium phosphate, dibasic heptahydrate;
0.2% by weight disodium EDTA;
6% by weight modified corn starch;
15% by weight zinc oxide;
1% by weight clotrimazole;
1% by weight hydrocortisone; and
0.1% by weight chlorocresol.

### Claim at position 7

-23. (canceled)

### Claim 24

A kit comprising:
optionally a first composition preferably being a first cream comprising non-medicated ingredients for skin protection;
a second composition preferably being a second cream comprising 0.1-1.1% by weight hydrocortisone and optionally zinc oxide;
a third composition preferably being a third cream comprising 0.1-1.1% by weight clotrimazole and optionally zinc oxide; and
optionally a fourth composition preferably being a fourth cream comprising one or more of a pH buffer, a moisturizing agent or humectant, an antimicrobial agent, or an antifungal agent;
wherein optionally one or more of the first, second, third and fourth cream comprise a proteolytic enzyme inhibitor.

### Claim at position 9

-26. (canceled)

### Claim 27 (depends on 24)

The kit of claim 24 comprising about 0.1-30% by weight the proteolytic enzyme inhibitor, preferably wherein the proteolytic enzyme inhibitor is a trypsin inhibitor.

### Claim 28 (depends on 24)

The kit of claim 24, wherein the fourth cream comprise the proteolytic enzyme inhibitor, wherein the proteolytic enzyme inhibitor comprises Soybean Trypsin Inhibitor (STI), Birk-Bowman Inhibitor (BBI), non-denatured soybean extract, or a combination thereof.

### Claim at position 12

-30. (canceled)

### Claim 31 (depends on 24)

The kit of claim 24, wherein the second and/or third cream comprises one or more of a pH buffer, a moisturizing agent or humectant, an antimicrobial agent, or an antifungal agent.

### Claim 32 (depends on 24)

The kit of claim 24, wherein:
the second cream comprises 1% by hydrocortisone and zinc oxide; and/or
the third cream comprises 1% by clotrimazole and zinc oxide.

### Claim 33

(canceled)

### Claim 34 (depends on 24)

The kit of claim 24, wherein the second and third creams are blended together prior to application to skin.

### Claim 35

(canceled)

### Claim 36 (depends on 1)

The therapeutic composition of claim 1:
i. packaged in a sealed container;
ii. embedded in a disposable wipe;
iii. packaged in an aerosol, spray pump or continuous spray container;
iv. packaged in a dab applicator;
v. embedded in the seal of a protective mask; or
vi. applied as a biofilm.

### Claim 37 (depends on 1)

A sprayable composition comprising the therapeutic composition of claim 1 and one or more spray components, wherein the one or more spray components comprise one or more of gelling agents, foaming agents, or spray-supporting solvents.

### Claim 38

(canceled)

### Claim 39 (depends on 24)

The kit of claim 24, wherein the second and third compositions are formulated together as a first sprayable composition and the kit further comprises a second sprayable composition, wherein:
the first sprayable composition comprises hydrocortisone, clotrimazole, petrolatum, water, cetearyl alcohol, ceteareth-20, Sodium phosphate and one or more spray components; and
the second sprayable composition comprises zinc oxide, petrolatum and one or more spray components;
wherein the one or more spray components of the first and second sprayable composition comprise gelling agents, foaming agents, or spray-supporting solvents.

### Claim 40

(canceled)

### Claim 41 (depends on 1)

A method for prevention or treatment of moisture-associated skin damage (MASD) in a subject, comprising:
topically applying to the skin of the subject from 1 to 100 g of a composition according to claim 1.

### Claim 42 (depends on 37)

A method for prevention or treatment of moisture-associated skin damage (MASD) with the kit of claim 37 [or 38], comprising:
spraying the first sprayable composition over a treatment area of a subject; and
spraying the second sprayable composition over the first sprayable composition and the treatment area.

### Claim 43 (depends on 41)

The method of claim 41, wherein the MASD is intertrigo or incontinence-associated dermatitis (IAD).

### Claim 44 (depends on 42)

The method of claim 42, wherein the MASD is intertrigo or incontinence-associated dermatitis (IAD).

### Claim 45 (depends on 44)

The method of claim 44, wherein the IAD is urinary incontinence, fecal incontinence, or combined urinary and fecal incontinence.

### Claim at position 28

-50. (canceled)

### Claim 51

A composition comprising a trypsin inhibitor and a carrier, for prevention or treatment of moisture-associated skin damage (MASD).

### Claim 52 (depends on 51)

The composition of claim 51, further comprising clotrimazole, hydrocortisone, and/or zinc oxicde.

### Claim 53 (depends on 51)

The composition of claim 51 being a sprayable composition, and optionally comprising zinc oxide.

### Claim 54 (depends on 43)

The method of claim 43, wherein the IAD is urinary incontinence, fecal incontinence, or combined urinary and fecal incontinence.

### Claim 55 (depends on 1)

A method of inhibiting fecal enzymes on a skin of a subject, the method comprising:
topically applying to the skin of the subject from 1 to 100 g of a composition according to claim 1.

### Claim 56 (depends on 24)

A method of inhibiting fecal enzymes on a skin of a subject, the method comprising:
topically applying to the skin of the subject one or both of the second and the third composition defined in the kit of claim 24 sequentially or in combination; and
optionally applying the fourth composition defined in the kit of claim 24.

### Claim 57

A composition comprising a trypsin inhibitor and a carrier, for inhibiting fecal enzymes on a skin of a subject.