A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Benzaclin Pharmacology, Pharmacokinetics, Studies, Metabolism - Clindamycin & Benzoyl Peroxide
Benzaclin Pharmacology, Pharmacokinetics, Studies, Metabolism - Clindamycin & Benzoyl Peroxide
CLINICAL PHARMACOLOGY
An in vitro percutaneous penetration study comparing BenzaClin
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 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.
CLINICALSTUDIES
In two adequate and well controlled clinical studies of 758
patients, 214 used BenzaClin, 210 used benzoyl peroxide, 168 used clindamycin,
and 166 used vehicle. BenzaClin 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 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 group showed greater overall improvement than
the benzoyl peroxide, clindamycin and vehicle groups as rated by the investigator.
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