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Medical Areas: Dermatology | Family Medicine
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Clindamycin phosphate topical gel
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Target Research Associates
Approval Status: Approved November 2000
Treatment Area: Acne vulgaris
Clindamycin phosphate topical gel, 1% is a topical antibiotic
approved for the treatment of acne vulgaris. This drug belongs to
the class of antibiotics known as lincosamides. By inhibiting
bacteria protein synthesis at the ribosomal level (the site of
protein synthesis), clindamycin is believed to kill bacteria
associated with acne.
The term "acne vulgaris" refers to the more common
form of acne, consisting of non-inflammatory and mildly
inflammatory lesions. The more severe form of acne is characterized
by the presence of nodules. Nearly 17 million people in the United
States have acne, making it the most common skin disease. Although
acne is not a serious health threat, severe acne can lead to
disfiguring, permanent scarring, which can be upsetting for people
who suffer from the disorder.
Trial results indicated that clindamycin phosphate gel was more
effective than a vehicle gel in the treatment of mild to moderate
acne vulgaris. The 12-week, multicenter, randomized,
vehicle-controlled trial compared clindamycin phosphate topical
gel, 1% once daily to a vehicle gel administered once daily.
The mean percent reduction in lesion counts at the end of
treatment was 51% for clindamycin phosphate gel versus 40% for the
vehicle gel for inflammatory lesions. For non-inflammatory lesions,
the mean percent reduction was 25% for clindamycin phosphate gel
and 12% for the vehicle gel. The total mean percent reduction in
lesion counts at the end of treatment was 38% for clindamycin
phosphate gel and 27% for the vehicle gel.
In a contact sensitization trial, four of the 200 subjects
appeared to develop suggestive evidence of allergic contact
sensitization to clindamycin phosphate gel. There was no signal for
contact sensitization in the clinical trials under normal use
Adverse reactions associated with the use of clindamycin
phosphate gel include itching and peeling skin.
Cases of diarrhea, bloody diarrhea, and colitis have been
reported as adverse reactions in subjects treated with oral and
parenteral (intravenous) formulations of clindamycin, and have been
reported rarely with topical clindamycin. Abdominal pain and
gastrointestinal disturbances, as well as gram-negative
folliculitis (bacterial infection and inflammation of hair
follicles), have also been reported in association with the use of
topical formulations of clindamycin.
Mechanism of Action
Although clindamycin phosphate is inactive in vitro, rapid in
vitro hydrolysis converts this compound to clindamycin which has
antibacterial activity. Clindamycin inhibits bacteria protein
synthesis at the ribosomal level by binding to the 50S ribosomal
subunit and affecting the process of peptide chain initiation.
(from FDA label)