# US 2014/0154237 A1 · Methods and kits for topical application, removal, and inactivation of therapeutic or cosmetic toxin compositions

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- Number: US 2014/0154237 A1
- Document ID: US20140154237A1
- Status: Published application
- Kind: A1
- Application number: 13/978,673
- Filed: 2011-12-22
- Published: 2014-06-05
- Earliest claimed: 2011-01-07
- Assignees: Revance Therapeutics, Inc.
- Inventors: Jacob Waugh; Curtis Ruegg
- Web page: https://patentgrep.com/patent/US20140154237A1

## CPC

- C12N 1/36: Adaptation or attenuation of cells
- A61K 8/0208: {Tissues; Wipes; Patches}
- A61K 8/20: Halogens; Compounds thereof
- A61K 8/29: Titanium; Compounds thereof
- A61K 8/66: Enzymes
- A61K 38/4893: {Botulinum neurotoxin (3.4.24.69)}
- A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system
- A61P 17/00: Drugs for dermatological disorders
- A61P 17/10: Anti-acne agents
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 21/00: Drugs for disorders of the muscular or neuromuscular system
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 25/06: Antimigraine agents
- A61Q 19/08: Anti-ageing preparations
- A61K 2800/81: Preparation or application process involves irradiation
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- 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
- A61Q: SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS

## Abstract

This invention relates to methods and kits for safely removing and inactivating topical therapeutic or cosmetic compositions. The methods and kits according to the invention are particularly well suited for removing and inactivating highly toxic substances.

## Claims

### Claim at position 1

1-34. (canceled)

### Claim 35

A method for removing a topically applied neurotoxin from a surface on a patient, the method comprising:
removing neurotoxin from the area with a removal agent; and
inactivating the removed neurotoxin with an inactivation agent.

### Claim 36 (depends on 35)

The method according to claim 35, wherein the neurotoxin is selected from the group consisting of botulinum toxin, tetanus toxin, saxitoxin, and tetrodotoxin.

### Claim 37 (depends on 36)

The method according to claim 36, wherein the toxin is botulinum toxin.

### Claim 38 (depends on 37)

The method according to claim 37, wherein the botulinum toxin comprises botulinum toxin serotype A.

### Claim 39 (depends on 38)

The method according to claim 38, wherein the botulinum toxin is a purified botulinum toxin molecule.

### Claim 40 (depends on 35)

The method according to claim 35, wherein the step of removing the toxin comprises wiping off the toxin.

### Claim 41 (depends on 35)

The method according to claim 35, wherein the step of inactivating the removed neurotoxin comprises one or more of the following
(1) combining the removed neurotoxin with a composition comprising an oxidizer;
(2) exposing the removed neurotoxin to an inactivation agent comprising electromagnetic radiation for photochemically degrading the neurotoxin;
(3) exposing the removed neurotoxin to an inactivation agent comprising a basic agent; or
(4) exposing the removed toxin to heat sufficient to thermally degrade the toxin.

### Claim 42 (depends on 41)

The method according to claim 41, wherein the oxidizer is biodegradable.

### Claim 43 (depends on 41)

The method according to claim 41, wherein oxidizer comprises sodium hypochlorite in powder form.

### Claim 44

(canceled)

### Claim 45

(canceled)

### Claim 46 (depends on 41)

The method according to claim 41, wherein the electromagnetic radiation comprises ultraviolet radiation.

### Claim 47

(canceled)

### Claim 48

(canceled)

### Claim 49

(canceled)

### Claim 50

(canceled)

### Claim 51 (depends on 41)

The method according to claim 41, wherein the basic agent has a pH greater than 13.

### Claim 52 (depends on 35)

The method according to claim 35, wherein the removal agent adsorbs or absorbs the neurotoxin.

### Claim 53

(canceled)

### Claim 54 (depends on 35)

The method according to claim 35, wherein the removal agent comprises a polymeric article comprising cellulose.

### Claim 55

(canceled)

### Claim 56 (depends on 55)

The method according to claim 55, wherein the polymeric article is selected from the group consisting of a paper towel, gauze, a swab, and a cotton ball.

### Claim 57

(canceled)

### Claim 58

(canceled)

### Claim 59

(canceled)

### Claim 60

(canceled)

### Claim 61

(canceled)

### Claim 62

(canceled)

### Claim 63

(canceled)

### Claim 64

(canceled)

### Claim 65 (depends on 46)

The method according to claim 46, wherein the ultraviolet radiation irradiates titanium dioxide to photochemically degrade the neurotoxin.

### Claim 66

(canceled)

### Claim 67 (depends on 41)

The method according to claim 41, wherein the basic agent has a pH greater than 13.

### Claim 68 (depends on 35)

The method according to claim 35, wherein the toxin is administered in a composition comprising a detectable dye.

### Claim 69 (depends on 68)

The method according to claim 68, wherein the step of removing toxin is repeated until the amount of detectable dye present on the treated area is below a predetermined threshold.

### Claim 70

A kit for topically applying a toxin, the kit comprising:
a composition comprising a toxin and a dye;
an applicator for topically applying the composition to an area in need of treatment;
a removal agent for removing excess toxin from the treated area; and
an inactivation agent for inactivating the excess toxin after it has been removed from the treated area.

### Claim 71 (depends on 70)

The kit according to claim 70, wherein the toxin is selected from the group consisting of botulinum toxin, tetanus toxin, saxitoxin, and tetrodotoxin.

### Claim 72 (depends on 71)

The kit according to claim 71, wherein the toxin is botulinum toxin serotype A.

### Claim 73

(canceled)

### Claim 74 (depends on 72)

The kit according to claim 72, wherein the botulinum toxin is a purified botulinum toxin molecule.

### Claim 75 (depends on 70)

The kit according to claim 70, wherein the applicator comprises a glove or a syringe.

### Claim 76

(canceled)

### Claim 77 (depends on 70)

The kit according to claim 70, wherein the removal agent absorbs or adsorbs the excess toxin.

### Claim 78

(canceled)

### Claim 79 (depends on 70)

The kit according to claim 70, wherein the removal agent comprises a polymeric article.

### Claim 80 (depends on 79)

The kit according to claim 79, wherein the polymeric article comprises cellulose.

### Claim 81 (depends on 80)

The kit according to claim 80, wherein the polymeric article is selected from the group consisting of a paper towel, a cotton ball, gauze, and a swab.

### Claim 82

(canceled)

### Claim 83

(canceled)

### Claim 84 (depends on 70)

The kit according to claim 70, wherein the inactivation agent comprises an oxidizer.

### Claim 85 (depends on 84)

The kit according to claim 84, wherein the oxidizer is biodegradable.

### Claim 86 (depends on 84)

The kit according to claim 84, wherein the inactivation agent comprises sodium hypochlorite.

### Claim 87

(canceled)

### Claim 88 (depends on 70)

The kit according to claim 70, wherein the inactivation agent comprises a source of electromagnetic radiation for photochemically degrading the toxin.

### Claim 89 (depends on 88)

The kit according to claim 88, wherein the electromagnetic radiation comprises ultraviolet radiation.

### Claim 90 (depends on 89)

The kit according to claim 89, wherein the composition further comprises titanium dioxide that is irradiated with the ultraviolet radiation to photochemically degrade the toxin.

### Claim 91 (depends on 70)

The kit according to claim 70, wherein inactivation agent is a basic agent.

### Claim 92 (depends on 91)

The kit according to claim 91, wherein the basic agent has a pH greater than 13.

### Claim 93

A kit for the disposal of a topically applied toxin, the kit comprising:
a removal agent for removing excess toxin topically applied to an area in need of treatment; and
an inactivation agent for inactivating the excess toxin after it has been removed from the treated area.

### Claim 94 (depends on 93)

The kit according to claim 93, wherein the removal agent adsorbs or absorbs the excess toxin.

### Claim 95

(canceled)

### Claim 96 (depends on 93)

The kit according to claim 93, wherein the removal agent comprises a polymeric article.

### Claim 97 (depends on 96)

The kit according to claim 96, wherein the polymeric article comprises cellulose.

### Claim 98 (depends on 97)

The kit according to claim 97, wherein the polymeric article is selected from the group consisting of a paper towel, gauze, a swab, and a cotton ball.

### Claim 99

(canceled)

### Claim 100

(canceled)

### Claim 101 (depends on 93)

The kit according to claim 93, wherein the inactivation agent comprises an oxidizer.

### Claim 102 (depends on 101)

The kit according to claim 101, wherein the oxidizer is biodegradable.

### Claim 103 (depends on 101)

The kit according to claim 101, wherein the inactivation agent comprises sodium hypochlorite.

### Claim 104 (depends on 103)

The kit according to claim 103, wherein the sodium hypochlorite is in powder form.

### Claim 105 (depends on 93)

The kit according to claim 93, wherein the inactivation agent comprises a source of electromagnetic radiation for photochemically degrading the toxin.

### Claim 106 (depends on 105)

The kit according to claim 105, wherein the electromagnetic radiation comprises ultraviolet radiation.

### Claim 107 (depends on 106)

The kit according to claim 106, wherein the composition further comprises titanium dioxide.

### Claim 108 (depends on 93)

The kit according to claim 93, wherein the inactivation agent is a basic agent.

### Claim 109 (depends on 108)

The kit according to claim 108, wherein the basic agent has a pH greater than 13.

### Claim 110

A composition comprising a botulinum toxin and a dye.

### Claim 111 (depends on 110)

The composition according to claim 110, wherein the dye is a visible dye.

### Claim 112 (depends on 110)

The composition according to claim 110, wherein the dye is a fluorescent dye.

### Claim 113 (depends on 111)

The composition according to claim 111, wherein the botulinum toxin is selected from the group consisting of botulinum toxin serotypes A, B, C1, D, E, F, and G.

### Claim 114 (depends on 112)

The composition according to claim 112, wherein the botulinum toxin is selected from the group consisting of botulinum toxin serotypes A, B, C1, D, E, F, and G.

### Claim 115 (depends on 113)

The composition according to claim 113, wherein the botulinum toxin is a purified botulinum toxin molecule.

### Claim 116 (depends on 114)

The composition according to claim 114, wherein the botulinum toxin is a purified botulinum toxin molecule.

### Claim 117 (depends on 111)

The composition according to claim 111, wherein the visible dye is an artificial dye.

### Claim 118 (depends on 117)

The composition according to claim 117, wherein the visible dye selected from the group consisting of FD&C Blue No. 1, FD&C Blue No. 2, FD&C Green No. 3, FD&C Red No. 40, FD&C Red No. 3, FD&C Yellow No. 5, and FD&C Red No. 6.

### Claim 119 (depends on 111)

The composition according to claim 111, wherein the visible dye is a natural food dye.

### Claim 120 (depends on 119)

The composition according to claim 119, wherein the visible dye is selected from the group consisting of caramel coloring, annatto, cochineal, betanin, turmeric, saffron, paprika, pandan, and butterfly pea.

### Claim 121 (depends on 120)

The composition according to claim 120, wherein the fluorescent dye is selected from the group consisting of fluorescein sodium, rhodamine B, Acridine Orange, green fluorescent protein, curcumin, and zinc sulfide.

### Claim 122 (depends on 9)

The method according to claim 9, wherein the sodium hypochlorite is in solution form.

### Claim 123 (depends on 86)

The kit according to claim 86, wherein the sodium hypochlorite is in solution form.

### Claim 124 (depends on 86)

The kit according to claim 86, wherein the sodium hypochlorite is in powder form.

### Claim 125 (depends on 103)

The kit according to claim 103, wherein the sodium hypochlorite is in solution form.

### Claim 126 (depends on 103)

The kit according to claim 103, wherein the sodium hypochlorite is in powder form.
