CA1220426A - Method of treating acne vulgaris and composition containing carbamide peroxide - Google Patents
Method of treating acne vulgaris and composition containing carbamide peroxideInfo
- Publication number
- CA1220426A CA1220426A CA000429965A CA429965A CA1220426A CA 1220426 A CA1220426 A CA 1220426A CA 000429965 A CA000429965 A CA 000429965A CA 429965 A CA429965 A CA 429965A CA 1220426 A CA1220426 A CA 1220426A
- Authority
- CA
- Canada
- Prior art keywords
- carbamide peroxide
- carrier
- volume
- composition
- acne vulgaris
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
ABSTRACT
A topical ointment, cream or lotion containing carbamide peroxide in an amount sufficient to be therapeuti-cally effective for the treatment of acne vulgaris including open and closed comedones. There is also disclosed a composi-tion effective in decreasing the inflammatory lesions of acne vulgaris in human patients having such inflammatory lesions comprising a carrier containing a therapeutically effective amount of carbamide peroxide in combination with a therapeuti-cally effective amount of one or more of a topical antibiotic, nicotinic acid or nicotinamide.
A topical ointment, cream or lotion containing carbamide peroxide in an amount sufficient to be therapeuti-cally effective for the treatment of acne vulgaris including open and closed comedones. There is also disclosed a composi-tion effective in decreasing the inflammatory lesions of acne vulgaris in human patients having such inflammatory lesions comprising a carrier containing a therapeutically effective amount of carbamide peroxide in combination with a therapeuti-cally effective amount of one or more of a topical antibiotic, nicotinic acid or nicotinamide.
Description
~:2~
The present invention relates to a composition for treating acne vulgaris.
Acne ~ulgaris i~ an inflammatory disease o~
the pilosebaceous glands characterized by an eruption ~ 5 of the skin, often pustular in nature but not sup-prative. Acne i5 a common affliction of the adolescent and affects a small but significant percentage of the adult population. Acne lesions are of four basic types: comedones tblackheads or whiteh~ads), papules, 10 pustules, and cysts (or nodules). Various topical agents are utilized in the treat~ent of acne and these include sulfur~ resorcinol, salicylic acid, benzoyl peroxide, vitamin A acid and topical antibiotics.
Acns involvement results in unsliyhtly lesions, par-15 ticularly on the face, and in some cases results insevere scarring.
There are a variety of me~hods for treating acne vulgaris including topically applying various scrubbing or abrasive compositions, topically applying 20 deep cleaning or astringent compositions and also ex-posure ~o ultraviolet radiation. Nevertheless, acne vulgaris is sel~om cured and only can be contained with difficulty. Carbamide peroxide i.s an a~ent used to soften earwax for removal. I have tested topical for-25 mulations containing carbamide peroxide for efectivenessin acne and found surprisingly that carbamide peroxide ~ applied topically to the skin is useful in the treat~
;: ~ ment of acne vulgaris. Also, surprisingly carbamide ; `
~ ., ~2~
peroxide achieves such beneficial effects without much of the irritating and sensitizing e~fec~s of ~en~oyl peroxide. We have also found that combinations o carba-mide peroxide with certain chemical agents known to be effective in treatiny acne are more effecti~e i.n treating acne than would be expected by treatment with the individual agents themse]ves. Such formulations include combinations of carbamide peroxide and one or more of nicotinamide or topical antibio~ics such as erythromycin base, clindamycin phosphate and tetracycline hydrochloride.
The present invention provides a composition effective in decreasing -the inflammatory lesions of acne vulgaris in human patients having such inflammatory lesions comprising a carrier containing a therapeutically efective amount of carbamide peroxide in combination with a therapeutically effective amount of one or more of a topical antibiotic, nicotinic acid or nicotinamide, the carbamide peroxide being present in the range of from about 1% to about 15~ by volume of the carrier.
The carrier may comprise various oryanic vehicles such as a combination of ethyl alcohol and propylene glycol.
Additionally, topical solutions of carbamide peroxide in various organic carriers in concentrations ranging from 1 to 15% by volume of the carrier are incorporated into various organic vehicles including solutions, lotions, creams, gels, and ointments along with one or more of the following ingredients:
nicotonic acid or nicotinamide in concentrations of from 1% to 10% by volume of the carrier; erythromycin base in concentrations of from 1~ to about 6% by volume of the carrier; clindamycin phosphate in con-centrations oE from 1 to 5% hy volume; tetracycline hydrochloride in concentrations of from 1 to 5~ by ~s ", .~1~,,.'~
, 14~
volume of the carrier. Such carriers useful for the incorporation of carbamide peroxide include combina~
tions of ethyl alcohol and propylene glycol as well as surface active agents such as lauryl ethers and 5 lauryl esters. Applications of the carrier and e- a fective ingredient are made to thP face of acne patients
The present invention relates to a composition for treating acne vulgaris.
Acne ~ulgaris i~ an inflammatory disease o~
the pilosebaceous glands characterized by an eruption ~ 5 of the skin, often pustular in nature but not sup-prative. Acne i5 a common affliction of the adolescent and affects a small but significant percentage of the adult population. Acne lesions are of four basic types: comedones tblackheads or whiteh~ads), papules, 10 pustules, and cysts (or nodules). Various topical agents are utilized in the treat~ent of acne and these include sulfur~ resorcinol, salicylic acid, benzoyl peroxide, vitamin A acid and topical antibiotics.
Acns involvement results in unsliyhtly lesions, par-15 ticularly on the face, and in some cases results insevere scarring.
There are a variety of me~hods for treating acne vulgaris including topically applying various scrubbing or abrasive compositions, topically applying 20 deep cleaning or astringent compositions and also ex-posure ~o ultraviolet radiation. Nevertheless, acne vulgaris is sel~om cured and only can be contained with difficulty. Carbamide peroxide i.s an a~ent used to soften earwax for removal. I have tested topical for-25 mulations containing carbamide peroxide for efectivenessin acne and found surprisingly that carbamide peroxide ~ applied topically to the skin is useful in the treat~
;: ~ ment of acne vulgaris. Also, surprisingly carbamide ; `
~ ., ~2~
peroxide achieves such beneficial effects without much of the irritating and sensitizing e~fec~s of ~en~oyl peroxide. We have also found that combinations o carba-mide peroxide with certain chemical agents known to be effective in treatiny acne are more effecti~e i.n treating acne than would be expected by treatment with the individual agents themse]ves. Such formulations include combinations of carbamide peroxide and one or more of nicotinamide or topical antibio~ics such as erythromycin base, clindamycin phosphate and tetracycline hydrochloride.
The present invention provides a composition effective in decreasing -the inflammatory lesions of acne vulgaris in human patients having such inflammatory lesions comprising a carrier containing a therapeutically efective amount of carbamide peroxide in combination with a therapeutically effective amount of one or more of a topical antibiotic, nicotinic acid or nicotinamide, the carbamide peroxide being present in the range of from about 1% to about 15~ by volume of the carrier.
The carrier may comprise various oryanic vehicles such as a combination of ethyl alcohol and propylene glycol.
Additionally, topical solutions of carbamide peroxide in various organic carriers in concentrations ranging from 1 to 15% by volume of the carrier are incorporated into various organic vehicles including solutions, lotions, creams, gels, and ointments along with one or more of the following ingredients:
nicotonic acid or nicotinamide in concentrations of from 1% to 10% by volume of the carrier; erythromycin base in concentrations of from 1~ to about 6% by volume of the carrier; clindamycin phosphate in con-centrations oE from 1 to 5% hy volume; tetracycline hydrochloride in concentrations of from 1 to 5~ by ~s ", .~1~,,.'~
, 14~
volume of the carrier. Such carriers useful for the incorporation of carbamide peroxide include combina~
tions of ethyl alcohol and propylene glycol as well as surface active agents such as lauryl ethers and 5 lauryl esters. Applications of the carrier and e- a fective ingredient are made to thP face of acne patients
2 to 4 times daily with th~ result that opPn and closed comedones ~blackheads and whiteheads) are markedly reduced within two weeks. The following examples il-10 lustrate th present invention.
Example 1 A 1% solution of carbamide peroxide was -- -prepared in an alcohol-propylene glycvl carrier. ~ice daily topical application of this solution were self-15 administered by a 26 year old female patient suffering from acne vulgaris. After two weeks of treatment the comedone count on the patient's face had declined from 2~ to 15.
Example 2 A 20 year-old male applied 10~ carbamide peroxide prepared in an alcohol gel containing 6%
polyoxyethylene lauryl ether four times daily. After 10 da}~s the number of comedones on his face had de- "-clined from 43 to 25 and by the end of four weeks o 2S treatment he had only 18 comedones on his face.
Example 3 A 30 year-old female with acne vulgaris ap-plied a 5~ by volume solution of carbamide peroxide in a 70~ ethyl alcohol and 30% propylene glycol carrier.
30 The product was applied to all involved areas of the face and back twice daily. Before treatment this patient had 64 comedones on the face and back but after two weeks of treatment she had only 41 comedones in these areas.
35 Example 4 A 2.5% carbamide peroxide cream was prepared containing water, propylene ~lycol, bentonite, glycerol stearate, isopropyl myristate and cellulose gum and ap-pli~d twice d~ily to the skin of a 24 y~ear-old male with many comedones on his forehead. After two weeks of such 5 treatment the number of comedones on his forehead had declined from 28 to 12.
A 26 year~old male who had belen unable to use 5 or 10~ ben20yl peroxide preparations due to rashes ' 10 each time he used them, applied a topical 5% carbamide peroxide preparation twice daily for eight weeks. The number of comedones declined over this treatment period ~ ~, from 46 to 29 at two weeks and to only 16 comedones s.
after eight weeks of therapy.
15 Example 6 An alcohol/aqueous solution containing 2.5%
carbamide peroxide and 6~ erythromycin was applied topically twice daily hy a 30 year-old female wi~h acne vulgaris consisting of both comedones (18) and papules 20 and pustules (12). After four weeks of treatment the patient's face was considerably clearer with only 8 comedones and 6 papules or pustules apparent.
A 14 year-old female with several comedones 25 and 15 small acne pustules,and pap~les applied a sol-ution comprised of 10~ carbamide peroxide and 2%
erythromycin in an alcohol-propylene glycol carrier.
After 8 weeks of one to t~ice daily treatment the sub-~ect'.s face was free o~ all but 2 small acne papules.
30 Example 8 A alcohol-propylene glycol vehicle containing ' 5~ carbamide peroxide and 2~ nicotinamide was applied four times daily by a 21 yeax -old male wit~ a mixture of comedones and papulo-pustules on his face. After 35'ten days o~ treatment his face was much improved and after foux weeks of such trea-tment, it was almDst com- ~, :
pletely clear.
Exampl e 9 1~ 16 year-old rnale wi~h moderate ~evere in-flammatory acne consisting of primarily papules and 5 pustules as well as a lessor number of comedones ap-plied a gel containing 15~ carbamide peroxide and 10 nicotinamide twice daily. The patient Is lesions al-most comple~ely cleared within ten (lO) days but he had to discontinue the product because of excessive lO chapping.
E m~
Carbamide peroxidP 5~ and clindomycin ~hos-phate 1% were incorporated into an alcoholic gel con-taining 6% polyoxyetheylene lauryl ether and applied to 15 the face twice daily by a 22 year-old male with acne vulgaris. This patient's comedone count decreased from 26 to lO and the papulo-pustule count from 16 to 8 ater 4 weeks o such treatment.
Example ll An aqueous/alcohol solution containing lO~
carbamide peroxide and 2.5% clindamycin phospl~ate was applied once daily by a 24 year-old female with acne comedones, papules and pustules on her face. After two weeks of treatm~nt she was noted to h~ve greater 25 than a 40% reduction in both comedones as well as `papulo-pustules.
Example 12 An aqueous/alcohol solution containing a salt of tetracyline such as tetracycline hydrochloride is 30 also useful in amounts o about 1% to about 5~ by vol-ume of the carrier when combined with an effective amount of carbamide peroxide.
The present invention inoludes within the scope thereof pharmaceutical compositions suitable for topical 35 administration having as an active ingredient thereo~
2~; :
carbamide peroxide, the chemical formula of t~hich is:
NH
J ~ H O
~H2 Also included in the scope of the invention is the com-bination of carbamide peroxide with on~ or more of 5 nicotinic acid or nicotinamide or a topical antiblotic such as erythromycin basel clindamycin phosphate and -~
tetracycline hydrochloride. Where appropriate a pharmaceutically acceptable carrier gel, or ointment is employed.
Liquid dosage forms for topical administration includes acceptable emulsions, solutions and suspension~
containing volatile diluents commonly used in the art, such as alcohol, glycol and the like. Besides such diluen~s, topically applied compositions may also in-15 clude wetting agents, emulsifying and suspending agents.
Example 1 A 1% solution of carbamide peroxide was -- -prepared in an alcohol-propylene glycvl carrier. ~ice daily topical application of this solution were self-15 administered by a 26 year old female patient suffering from acne vulgaris. After two weeks of treatment the comedone count on the patient's face had declined from 2~ to 15.
Example 2 A 20 year-old male applied 10~ carbamide peroxide prepared in an alcohol gel containing 6%
polyoxyethylene lauryl ether four times daily. After 10 da}~s the number of comedones on his face had de- "-clined from 43 to 25 and by the end of four weeks o 2S treatment he had only 18 comedones on his face.
Example 3 A 30 year-old female with acne vulgaris ap-plied a 5~ by volume solution of carbamide peroxide in a 70~ ethyl alcohol and 30% propylene glycol carrier.
30 The product was applied to all involved areas of the face and back twice daily. Before treatment this patient had 64 comedones on the face and back but after two weeks of treatment she had only 41 comedones in these areas.
35 Example 4 A 2.5% carbamide peroxide cream was prepared containing water, propylene ~lycol, bentonite, glycerol stearate, isopropyl myristate and cellulose gum and ap-pli~d twice d~ily to the skin of a 24 y~ear-old male with many comedones on his forehead. After two weeks of such 5 treatment the number of comedones on his forehead had declined from 28 to 12.
A 26 year~old male who had belen unable to use 5 or 10~ ben20yl peroxide preparations due to rashes ' 10 each time he used them, applied a topical 5% carbamide peroxide preparation twice daily for eight weeks. The number of comedones declined over this treatment period ~ ~, from 46 to 29 at two weeks and to only 16 comedones s.
after eight weeks of therapy.
15 Example 6 An alcohol/aqueous solution containing 2.5%
carbamide peroxide and 6~ erythromycin was applied topically twice daily hy a 30 year-old female wi~h acne vulgaris consisting of both comedones (18) and papules 20 and pustules (12). After four weeks of treatment the patient's face was considerably clearer with only 8 comedones and 6 papules or pustules apparent.
A 14 year-old female with several comedones 25 and 15 small acne pustules,and pap~les applied a sol-ution comprised of 10~ carbamide peroxide and 2%
erythromycin in an alcohol-propylene glycol carrier.
After 8 weeks of one to t~ice daily treatment the sub-~ect'.s face was free o~ all but 2 small acne papules.
30 Example 8 A alcohol-propylene glycol vehicle containing ' 5~ carbamide peroxide and 2~ nicotinamide was applied four times daily by a 21 yeax -old male wit~ a mixture of comedones and papulo-pustules on his face. After 35'ten days o~ treatment his face was much improved and after foux weeks of such trea-tment, it was almDst com- ~, :
pletely clear.
Exampl e 9 1~ 16 year-old rnale wi~h moderate ~evere in-flammatory acne consisting of primarily papules and 5 pustules as well as a lessor number of comedones ap-plied a gel containing 15~ carbamide peroxide and 10 nicotinamide twice daily. The patient Is lesions al-most comple~ely cleared within ten (lO) days but he had to discontinue the product because of excessive lO chapping.
E m~
Carbamide peroxidP 5~ and clindomycin ~hos-phate 1% were incorporated into an alcoholic gel con-taining 6% polyoxyetheylene lauryl ether and applied to 15 the face twice daily by a 22 year-old male with acne vulgaris. This patient's comedone count decreased from 26 to lO and the papulo-pustule count from 16 to 8 ater 4 weeks o such treatment.
Example ll An aqueous/alcohol solution containing lO~
carbamide peroxide and 2.5% clindamycin phospl~ate was applied once daily by a 24 year-old female with acne comedones, papules and pustules on her face. After two weeks of treatm~nt she was noted to h~ve greater 25 than a 40% reduction in both comedones as well as `papulo-pustules.
Example 12 An aqueous/alcohol solution containing a salt of tetracyline such as tetracycline hydrochloride is 30 also useful in amounts o about 1% to about 5~ by vol-ume of the carrier when combined with an effective amount of carbamide peroxide.
The present invention inoludes within the scope thereof pharmaceutical compositions suitable for topical 35 administration having as an active ingredient thereo~
2~; :
carbamide peroxide, the chemical formula of t~hich is:
NH
J ~ H O
~H2 Also included in the scope of the invention is the com-bination of carbamide peroxide with on~ or more of 5 nicotinic acid or nicotinamide or a topical antiblotic such as erythromycin basel clindamycin phosphate and -~
tetracycline hydrochloride. Where appropriate a pharmaceutically acceptable carrier gel, or ointment is employed.
Liquid dosage forms for topical administration includes acceptable emulsions, solutions and suspension~
containing volatile diluents commonly used in the art, such as alcohol, glycol and the like. Besides such diluen~s, topically applied compositions may also in-15 clude wetting agents, emulsifying and suspending agents.
Claims (6)
1. A composition effective in decreasing the inflammatory lesions of acne vulgaris in human patients having such inflammatory lesions comprising a carrier containing a therapeutically effective amount of carbamide peroxide in combination with a therapeutically effective amount of one or more of a topical antibiotic, nicotinic acid or nicotinamide, the carbamide peroxide being present in the range of from about 1% to about 15% by volume of the carrier.
2. The composition of claim 1, wherein the effective ingredients include carbamide peroxide present in an amount not less than about 1% by volume of the carrier.
3. The composition of claim 1, wherein the effective ingredients include erythromycin base present in the range of from about 1% to about 6% by volume of the carrier.
4. The composition of claim 1, wherein the effective ingredients include clindamycin phosphate present in the range of from about 1% to about 5% by volume of the carrier.
5. The composition of claim 1, wherein the effective ingredients include tetracycline hydrochloride present in the range of from about 1% to about 5% by volume of the carrier.
6. The composition of claim 1, wherein the effective ingredients include nicotinamide present in the range of from about 1% to about 10% by volume of the carrier.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA000429965A CA1220426A (en) | 1983-06-08 | 1983-06-08 | Method of treating acne vulgaris and composition containing carbamide peroxide |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA000429965A CA1220426A (en) | 1983-06-08 | 1983-06-08 | Method of treating acne vulgaris and composition containing carbamide peroxide |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1220426A true CA1220426A (en) | 1987-04-14 |
Family
ID=4125436
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000429965A Expired CA1220426A (en) | 1983-06-08 | 1983-06-08 | Method of treating acne vulgaris and composition containing carbamide peroxide |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA1220426A (en) |
-
1983
- 1983-06-08 CA CA000429965A patent/CA1220426A/en not_active Expired
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