# US 12,599,550 B2 · High dose and low volume botulinum toxin treatment of facial wrinkles

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- Number: US 12,599,550 B2
- Document ID: US12599550B2
- Status: Granted
- Kind: B2
- Application number: 18/007,712
- Filed: 2021-06-04
- Published: 2023-10-19
- Granted: 2026-04-14
- Earliest claimed: 2020-06-05
- Assignees: MERZ PHARMA GmbH & CO. KGaA
- Applicants: Merz Pharma GmbH & Co. KGAA
- Inventors: Susanna Roll; Meik Sladek; Thorin Geister; Irena Pulte; Petra Weissenberger; Gudrun Klein
- Web page: https://patentgrep.com/patent/US12599550B2

## CPC

- A61K 8/64: Proteins; Peptides; Derivatives or degradation products thereof
- A61K 8/66: Enzymes
- A61Q 19/08: Anti-ageing preparations
- C12Y 304/24069: Bontoxilysin (3.4.24.69), i.e. botulinum neurotoxin
- A61K 2800/91: Injection
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- 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)
- A61Q: SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- C12Y: ENZYMES
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

The present invention relates the use of botulinum toxin for the treatment of facial wrinkles, wherein botulinum toxin is administered at high doses (e.g., 50 U to 200 U) using small injection volumes (e.g., 0.05 ml to 0.35 ml). Furthermore, the present invention relates to a method for the treatment of facial wrinkles (e.g., glabellar frown lines) by injecting small volumes of a highly concentrated botulinum toxin solution into a target facial area of a subject.

## Claims

### Claim 1

A method of treating facial wrinkles comprising injecting botulinum toxin in a facial area of a subject at a total dose of 50 U to 200 U and a total volume of 0.05 ml to 0.35 ml to treat said facial wrinkles,
wherein the botulinum toxin is the neurotoxic component of botulinum toxin serotype A.

### Claim 2 (depends on 1)

The method of claim 1, wherein the botulinum toxin is injected at a total dose of 50 U to 175 U or 60 U to 150 U or 70 U to 125 U or 75 U to 100 U.

### Claim 3 (depends on 1)

The method of claim 1, wherein the botulinum toxin is injected in a total volume of 0.10 ml to 0.35 ml or 0.10 ml to 0.30 ml or 0.15 ml to 0.35 ml or 0.15 ml to 0.30 ml.

### Claim 4 (depends on 1)

The method of claim 1, wherein the botulinum toxin is injected at a concentration of 150 U/ml to 2000 U/ml or 200 U/ml to 1500 U/ml or 250 U/ml to 1000 U/ml or 300 U/ml to 800 U/ml or 350 U/ml to 600 U/ml.

### Claim 5 (depends on 1)

The method of claim 1, wherein the botulinum toxin is injected at 3 to 8 injection points and/or wherein the botulinum toxin is injected at a dose of 6 U to 50 U at each injection point.

### Claim 6 (depends on 5)

The method of claim 5, wherein the botulinum toxin is injected in a volume of 0.02 ml to 0.14 ml or 0.03 ml to 0.10 ml or 0.04 ml to 0.06 ml at each site of injection.

### Claim 7 (depends on 1)

The method of claim 1, wherein the botulinum toxin is used in the treatment of horizontal forehead lines, glabellar frown lines, periorbitallines, Crow's feet, bunny lines, nasolabial folds, upper radiallip lines, lower radiallip lines, corner of the mouth lines, marionette lines, periorallip lines, oral commissures, labiomental crease and cobblestone chin, optionally horizontal forehead lines, glabellar frown lines, and periorbitallines including Crow's feet.

### Claim 8 (depends on 1)

The method of claim 1, wherein the subject is a subject with moderate or severe glabellar frown lines, or severe glabellar frown lines, based on assessment by investigator using the Facial Wrinkle Scale (FWS) at maximum frown.

### Claim 9 (depends on 1)

The method of claim 1, wherein the subject is a female subject.

### Claim 10 (depends on 1)

The method of claim 1, wherein the botulinum toxin is used in the treatment of glabellar frown lines, and wherein the botulinum toxin is injected at 4, 5 or 6 intramuscular injection points, at a total dose of 50 U to 150 U and in a total volume of 0.15 to 0.35 ml.

### Claim 11 (depends on 10)

The method of claim 10, wherein the botulinum neurotoxin is used in the treatment of moderate or severe glabellar frown lines or severe glabellar frown lines, based on investigator ratings using the Facial Wrinkle Scale (FWS) at maximum frown, and wherein the botulinum toxin is injected (i) at a total dose of 70 U to 130 U and in a total volume of 0.15 ml to 0.35 ml or (ii) at a total dose of 80 U to 120 U and in a total volume of 0.15 ml to 0.25 ml.

### Claim 12 (depends on 1)

The method of claim 1, wherein the botulinum toxin is administered at an interval of 6 to 9 months between two consecutive treatment sessions.