# US 8,785,420 B2 · Combination/association of adapalene and benzoyl peroxide for treating acne lesions

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- Number: US 8,785,420 B2
- Document ID: US8785420B2
- Status: Granted
- Kind: B2
- Application number: 13/351,986
- Filed: 2012-01-17
- Published: 2012-05-10
- Granted: 2014-07-22
- Earliest claimed: 2006-07-13
- Assignees: Galderma Research & Development
- Applicants: Marie-Line Abou Chacra Vernet; Denis Gross; Christian Loesche; Michel Poncet
- Inventors: Marie-Line Abou Chacra Vernet; Denis Gross; Christian Loesche; Michel Poncet
- Web page: https://patentgrep.com/patent/US8785420B2

## CPC

- A61K 31/327: Peroxy compounds, e.g. hydroperoxides, peroxides, peroxyacids
- 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 31/192: having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid {(cannabinoids A61K31/658)}
- A61P 17/00: Drugs for dermatological disorders
- A61P 17/10: Anti-acne agents
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 47/18: Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K 47/20: containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
- A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
- A61K 47/32: Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers {, poly(meth)acrylates, or polyvinyl pyrrolidone}
- 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

Acne lesions, whether of inflammatory and/or non-inflammatory type, are simultaneously or sequentially treated and their number reduced, via daily topical regimen, with the combination or association of adapalene or pharmaceutically acceptable salt thereof and benzoyl peroxide (BPO).

## Claims

### Claim 1

A regimen for the therapeutic treatment of acne lesions, the regimen comprising topically applying to the skin of a subject in need of said treatment, as active ingredients, 0.1% to 0.3% adapalene and 2.5% benzoyl peroxide, combined at fixed doses in a single formula that delivers said active ingredients together synergistically to achieve, in a group of such subjects, a degree of success of at least about 20%, wherein said single formula is applied once daily for a period of 12 weeks.

### Claim 2 (depends on 1)

The regimen of claim 1, wherein the single formula is a gel.

### Claim 3

A regimen for the therapeutic treatment of acne lesions, the regimen comprising topically applying to the skin of a subject in need of said treatment, as active ingredients, 0.1% to 0.3% adapalene and 2.5% benzoyl peroxide, combined at fixed doses in a single formula that delivers said active ingredients together synergistically to reduce the number of total acne lesions by at least 40%, wherein said single formula is applied once daily for a period of 12 weeks.

### Claim 4 (depends on 3)

The regimen of claim 3, wherein the single formula is a gel.

### Claim 5

A regimen for the therapeutic treatment of acne lesions, the regimen comprising topically applying to the skin of a subject in need of said treatment, as active ingredients, 0.1% to 0.3% adapalene and 2.5% benzoyl peroxide, combined at fixed doses in a single formula that delivers said active ingredients together synergistically to reduce the number of non-inflammatory acne lesions by at least 40%, wherein said single formula is a gel which is applied once daily for a period of 12 weeks.

### Claim 6

A regimen for the therapeutic treatment of acne lesions, the regimen comprising topically applying to the skin of a subject in need of said treatment, as active ingredients, 0.1% to 0.3% adapalene and 2.5% benzoyl peroxide, combined at fixed doses in a single formula that delivers said active ingredients together synergistically to reduce the number of inflammatory acne lesions by at least 50%, wherein said single formula is a gel which is applied once daily for a period of 12 weeks.

### Claim 7

A regimen for the therapeutic treatment of acne lesions, the regimen comprising topically applying to the skin of a subject in need of such treatment, as active ingredients, 0.1% to 0.3% adapalene and 2.5% benzoyl peroxide, combined at fixed doses in a single formula that delivers said active ingredients together synergistically to reduce the number of inflammatory lesions by at least 40%, wherein said single formula is applied once daily for a period of 12 weeks.

### Claim 8 (depends on 7)

The regimen of claim 7, wherein the single formula is a gel.

### Claim 9

A regimen for the therapeutic treatment of acne lesions, the regimen comprising topically applying to the skin of a subject in need of said treatment, as active ingredients, 0.1% to 0.3% adapalene and 2.5% benzoyl peroxide, combined at fixed doses in a single formula that delivers said active ingredients together synergistically to reduce the number of total acne lesions by at least 40%, to reduce the number of non-inflammatory acne lesions by at least 40%, to reduce the number of inflammatory acne lesions by at least 40% and to achieve in a group of such subjects, a degree of success of at least about 20%, wherein said single formula is applied once daily for a period of 12 weeks.

### Claim 10 (depends on 9)

The regimen of claim 9, wherein the single formula is a gel.

### Claim 11

A regimen for providing early onset of action in reducing total lesion counts in the therapeutic treatment of acne lesions, the regimen comprising topically applying to the skin of a subject in need of said treatment, as active ingredients, 0.1% to 0.3% adapalene and 2.5% benzoyl peroxide, combined at fixed doses in a single formula that delivers said active ingredients together, wherein said single formula is applied once daily for a period of 1, 2, or 4 weeks, and wherein the net reduction in total lesion counts in a group of such subjects, at week 1, week 2 or week 4, respectively, is numerically superior to the sum of the net reductions in total lesion counts achieved by the same dose of adapalene alone and of benzoyl peroxide alone at the corresponding time point.

### Claim 12 (depends on 11)

The regimen of claim 11, wherein the single formula is a gel.