1. Systemic exposure to benzoic acid and hippuric acid following topical application of clindamycin 1%/benzoyl peroxide 3% fixed-dose combination gel in Japanese patients with acne vulgaris.
- Author
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Ino H, Takahashi N, Saenz AA, Wakamatsu A, Hashimoto H, Nakahara N, and Hasegawa S
- Subjects
- Acne Vulgaris blood, Acne Vulgaris diagnosis, Acne Vulgaris ethnology, Administration, Cutaneous, Adult, Anti-Bacterial Agents adverse effects, Area Under Curve, Asian People, Benzoic Acid blood, Benzoic Acid urine, Benzoyl Peroxide adverse effects, Biotransformation, Clindamycin adverse effects, Dermatologic Agents adverse effects, Drug Administration Schedule, Drug Combinations, Drug Monitoring methods, Hippurates blood, Hippurates urine, Humans, Japan, Male, Metabolic Clearance Rate, Young Adult, Acne Vulgaris drug therapy, Anti-Bacterial Agents administration & dosage, Anti-Bacterial Agents pharmacokinetics, Benzoic Acid pharmacokinetics, Benzoyl Peroxide administration & dosage, Benzoyl Peroxide pharmacokinetics, Clindamycin administration & dosage, Clindamycin pharmacokinetics, Dermatologic Agents administration & dosage, Dermatologic Agents pharmacokinetics, Hippurates pharmacokinetics
- Abstract
Clindamycin 1%/benzoyl peroxide 3% fixed-dose combination gel (CLDM/BPO3%) is a topical product for the treatment of acne vulgaris. In this study, plasma and urine concentrations of benzoic acid (BA) and hippuric acid (HA) were analyzed to estimate the pharmacokinetics (PK) of BPO after application of CLDM/BPO3% twice-daily for 7 days in Japanese patients with acne vulgaris. Seven-day repeated application of CLDM/BPO3% appears to be safe in this patient population. Concentrations of plasma and urine BA were below the limit of quantification before and after repeated application in most of the 12 adult male patients. Mean difference in Cmax and AUC0-last for plasma HA indicated increased exposures after repeated application, but with wide 90% confidence intervals. Mean Ae0-12 for urine HA was similar before and after repeated application. Repeated application of CLDM/BPO3% is thus unlikely to result in accumulation of BA and HA. The study suggests negligible systemic exposure to BPO metabolites from CLDM/BPO3% after 7-day repeated application in male patients with acne vulgaris., (© 2014, The American College of Clinical Pharmacology.)
- Published
- 2015
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