Overview
Benzoyl peroxide is a commonly used drug in topical treatments for acne. It has been formulated as products with either a single active ingredient, or with erythromycin, clindamycin, or adapalene. After administration, the peroxide bond is cleaved, allowing benzoyloxy radicals to nonspecifically interact with proteins. This treatment decreases keratin and sebum around follicles, as well as increasing turnover of epithelial cells. Benzoyl peroxide, in combination with erythromycin, was granted FDA approval on 26 October 1984.
Indication
Benzoyl peroxide is formulated with antibiotics such as erythromycin and clindamycin for the treatment of acne vulgaris. Benzoyl peroxide is formulated as a number of topical products for the treatment of acne. Benzoyl peroxide is also indicated in combination with tretinoin for the treatment of acne vulgaris in patients aged nine years and older. A triple-combination therapy including both clindamycin and adapalene is also available and indicated for the treatment of acne vulgaris in patients ≥12 years of age. Topical benzoyl peroxide is also indicated for the treatment of inflammatory lesions of rosacea in adults.
Associated Conditions
- Acne
- Acne Vulgaris
- Inflammatory Acne Vulgaris
- Inflammatory lesions caused by rosacea
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2014/07/17 | Not Applicable | Completed | |||
2014/02/27 | Phase 3 | Completed | |||
2013/12/09 | Phase 3 | Completed | |||
2013/02/22 | Phase 3 | Completed | |||
2013/01/17 | Phase 1 | Completed | |||
2013/01/16 | Phase 1 | Completed | |||
2012/12/05 | Phase 1 | Completed | |||
2012/02/06 | Phase 1 | Completed | |||
2012/01/31 | Phase 4 | Completed | |||
2011/12/29 | Not Applicable | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Physicians Total Care, Inc. | 54868-5617 | TOPICAL | 50 mg in 1 g | 10/20/2010 | |
| Summers Laboratories Inc | 11086-032 | TOPICAL | 5 g in 100 g | 10/9/2023 | |
| Sincerus Florida, LLC | 72934-1005 | TOPICAL | 2.5 g in 100 g | 6/3/2020 | |
| Physicians Total Care, Inc. | 54868-5991 | TOPICAL | 25 mg in 1 g | 2/7/2012 | |
| Bryant Ranch Prepack | 72162-1430 | TOPICAL | 2.5 g in 100 g | 3/13/2024 | |
| Zydus Pharmaceuticals USA Inc. | 70710-1445 | TOPICAL | 50 mg in 1 g | 10/5/2022 | |
| Mayne Pharma Inc. | 68308-662 | TOPICAL | 25 mg in 1 g | 12/5/2022 | |
| Sincerus Florida LLC | 72934-1016 | TOPICAL | 5 g in 100 g | 5/2/2019 | |
| Padagis Israel Pharmaceuticals Ltd | 45802-853 | TOPICAL | 25 mg in 1 g | 6/2/2022 | |
| Bryant Ranch Prepack | 72162-1432 | TOPICAL | 25 mg in 1 g | 3/13/2024 |
EMA Drug Approvals
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|---|---|---|---|
| No EMA approvals found for this drug. | |||
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|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
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|---|---|---|---|---|---|
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
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Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| PAULA'S CHOICE CLEAR ANTI-ACNE REGULAR STRENGTH SYSTEM | paula's choice llc | 02436469 | Solution
,
Kit
,
Lotion - Topical | 2.5 % / W/W | N/A |
| NEUTROGENA* ACNE MASK, OIL ABSORBING CLAY BASE | johnson & johnson inc | 02238313 | Paste - Topical | 5 % | 7/31/1999 |
| OXY 5 REGULAR STRENGTH VANISHING LOT 5% | smithkline beecham consumer healthcare, division of smithkline beecham inc. | 02045303 | Lotion - Topical | 5 % | 12/31/1994 |
| SPECTRO ACNECARE SPOT TREATMENT | glaxosmithkline consumer healthcare ulc | 02428814 | Gel - Topical | 3 % / W/W | N/A |
| TACTUPUMP FORTE | galderma canada inc | 02446235 | Gel - Topical | 2.5 % / W/W | 1/4/2016 |
| SERIOUS ACTION SKIN MEDICATION NO. 5 | glymed plus canada | 02272717 | Lotion - Topical | 5 % | N/A |
| SERIOUS ACTION EXFOLIANT WASH | glymed plus canada | 02273799 | Liquid - Topical | 2.5 % | N/A |
| PERSACLEAR | johnson & johnson inc | 02373157 | Cream - Topical | 10 % / W/W | N/A |
| CLINIQUE ACNE SOLUTIONS ALL-OVER CLEARING TREATMENT | clinique laboratories dist | 02290561 | Lotion - Topical | 2.5 % / W/W | 7/3/2007 |
| CLEAR PORE ON-THE SPOT ACNE TREATMENT,TINTED | johnson & johnson inc | 02238312 | Lotion - Topical | 2.5 % | 7/31/1999 |
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UK EMC Drug Information
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| No UK EMC drug information found for this drug. | |||||
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