Clindagel

In one 12-week multicenter, randomized, evaluator-blind, vehicle-controlled, parallel comparison clinical trial in which patients used

(clindamycin phosphate topical gel, 1%) once daily or the vehicle gel once daily, in the treatment of acne vulgaris of mild to moderate severity, applied once daily was more effective than the vehicle applied once daily. The mean percent reductions in lesion counts at the end of treatment in this study are shown in the following table:

Lesions	CLINDAGEL QD N=162	Vehicle Gel QD N=82
Inflammatory	51%	40% P<0.05
Noninflammatory	25%	12%
Total	38%	27%

There was a trend in the investigator’s global assessment of the results, which favored 

QD over the vehicle QD. 

In a contact sensitization study, four of the 200 subjects appeared to develop suggestive evidence of allergic contact sensitization to

There was no signal for contact sensitization in the clinical trials under normal use conditions.

Apply a thin film of

once daily to the skin where acne lesions appear. Use enough to cover the entire affected area lightly.

Keep container tightly closed.

In the one well-controlled clinical study comparing

and its vehicle, the incidence of skin and appendages adverse events occurring in ≥1% of the patients in either group is presented in the following table:

Dermatitis Dermatitis contact Dermatitis fungal FolliculitisPhotosensitivity reaction PruritusRash erythematous Skin dry Peeling

	Number (%) of Patients
Body System/Adverse Event	CLINDAGEL QD N=168	Vehicle Gel QD N=84
Skin and Appendages Disorders
0 (0.0)	1 (1.2)
0 (0.0)	1 (1.2)
0 (0.0)	1 (1.2)
0 (0.0)	1 (1.2)
0 (0.0)	1 (1.2)
1 (0.6)	1 (1.2)
0 (0.0)	0 (0.0)
0 (0.0)	0 (0.0)
1 (0.6)	0 (0.0)

Orally and parenterally administered clindamycin has been associated with severe colitis, which may end fatally.

Cases of diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported as adverse reactions in patients treated with oral and parenteral formulations of clindamycin and rarely with topical clindamycin (see

). Abdominal pain and gastrointestinal disturbances, as well as gram-negative folliculitis, have also been reported in association with the use of topical formulations of clindamycin.

(clindamycin phosphate) topical gel, 1%, a topical antibiotic, contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram in a gel vehicle consisting of carbomer 941, methylparaben, polyethylene glycol 400, propylene glycol, purified water, and sodium hydroxide. Chemically, clindamycin phosphate is a water-soluble ester of the semi-synthetic antibiotic produced by a 7 (S)-chlorosubstitution of the 7 (R)-hydroxyl group of the parent antibiotic, lincomycin, and has the structural formula represented below:      

The chemical name for clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-

-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L--α-D--octopyranoside 2-(dihydrogen phosphate).

In an open-label, parallel group study of 24 patients with acne vulgaris, once-daily topical administration of approximately 3 to 12 grams/day of for 5 days resulted in peak plasma clindamycin concentrations that were less than 5.5 ng/mL.

Following multiple applications of C

less than 0.04% of the total dose was excreted in the urine.

Although clindamycin phosphate is inactive  , rapid   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. studies indicated that clindamycin inhibited all tested   cultures at a minimum inhibitory concentration (MIC) of 0.4 mcg/mL. Cross-resistance has been demonstrated between clindamycin and erythromycin.