BenzaClin

CLINICAL PHARMACOLOGY

An in vitro percutaneous penetration study comparing BenzaClin (clindamycin and benzoyl peroxide) Topical Gel and topical 1% clindamycin gel alone, demonstrated there was no statistical difference in penetration between the two drugs. Mean systemic bioavailability of topical clindamycin in BenzaClin (clindamycin and benzoyl peroxide) Topical Gel is suggested to be less than 1%.

Benzoyl peroxide has been shown to be absorbed by the skin where it is converted to benzoic acid. Less than 2% of the dose enters systemic circulation as benzoic acid. It is suggested that the lipophilic nature of benzoyl peroxide acts to concentrate the compound into the lipid-rich sebaceous follicle.

Microbiology

The clindamycin and benzoyl peroxide components individually have been shown to have in vitro activity against Propionibacterium acnes an organism which has been associated with acne vulgaris; however, the clinical significance of this activity against P. acnes was not examined in clinical trials with this product.

Clinical Studies

In two adequate and well controlled clinical studies of 758 patients, 214 used BenzaClin (clindamycin and benzoyl peroxide) , 210 used benzoyl peroxide, 168 used clindamycin, and 166 used vehicle. BenzaClin (clindamycin and benzoyl peroxide) applied twice daily for 10 weeks was significantly more effective than vehicle in the treatment of moderate to moderately severe facial acne vulgaris. Patients were evaluated and acne lesions counted at each clinical visit; weeks 2, 4, 6, 8 and 10. The primary efficacy measures were the lesion counts and the investigator's global assessment evaluated at week 10. Patients were instructed to wash the face with a mild soap, using only the hands. Fifteen minutes after the face was thoroughly dry, application was made to the entire face. Non-medicated make-up could be applied at one hour after the BenzaClin (clindamycin and benzoyl peroxide) application. If a moisturizer was required, the patients were provided a moisturizer to be used as needed. Patients were instructed to avoid sun exposure. Percent reductions in lesion counts after treatment for 10 weeks in these two studies are shown below:

Study 1
BenzaClin
n=120
Benzoyl
peroxide
n=120
Clindamycin
n=120
Vehicle
n=120
Mean percent reduction in inflammatory lesion counts
46% 32% 16% + 3%
Mean percent reduction in non-inflammatory lesion counts
22% 22% 9% +1%
Mean percent reduction in total lesion counts
36% 28% 15% 0.2%
Study 2
BenzaClin
n=95
Benzoyl
peroxide
n=95
Clindamycin
n=49
Vehicle
n=48
Mean percent reduction in inflammatory lesion counts
63% 53% 45% 42%
Mean percent reduction in non-inflammatory lesion counts
54% 50% 39% 36%
Mean percent reduction in total lesion counts
58% 52% 42% 39%

The BenzaClin (clindamycin and benzoyl peroxide) group showed greater overall improvement than the benzoyl peroxide, clindamycin and vehicle groups as rated by the investigator.

Last reviewed on RxList: 7/7/2009
This monograph has been modified to include the generic and brand name in many instances.

A A A

BenzaClin - User Reviews

BenzaClin User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication BenzaClin sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.


NIH talks about Ebola on WebMD