"The U.S. Food and Drug Administration today approved Differin Gel 0.1% (adapalene), a once-daily topical gel for the over-the-counter (OTC) treatment of acne. Differin Gel 0.1% is approved for use in people 12 years of age and older.
Mechanism of Action
Mechanism of action in acne vulgaris is unknown. [See Microbiology]
Pharmacodynamics of EVOCLIN Foam is unknown.
In an open label, parallel group study in 24 subjects with acne vulgaris, 12 subjects (3 male and 9 female) applied 4 grams of EVOCLIN Foam once-daily for five days, and 12 subjects (7 male and 5 female) applied 4 grams of a clindamycin gel, 1%, once daily for five days. On Day 5, the mean Cmax and AUC(0-12) were 23% and 9% lower, respectively, for EVOCLIN Foam than for the clindamycin gel, 1%.
Following multiple applications of EVOCLIN Foam, less than 0.024% of the total dose was excreted unchanged in the urine over 12 hours on Day 5.
No microbiology studies were conducted in the clinical trials with this product.
Clindamycin binds to the 50S ribosomal subunits of susceptible bacteria and prevents elongation of peptide chains by interfering with peptidyl transfer, thereby suppressing protein synthesis. Clindamycin has been shown to have in vitro activity against Propionibacterium acnes (P. acnes), an organism that has been associated with acne vulgaris; however, the clinical significance of this activity against P. acnes was not examined in clinical studies with EVOCLIN Foam. P. acnes resistance to clindamycin has been documented.
Inducible Clindamycin Resistance
The treatment of acne with antimicrobials is associated with the development of antimicrobial resistance in P. acnes as well as other bacteria (e.g. Staphylococcus aureus, Streptococcus pyogenes). The use of clindamycin may result in developing inducible resistance in these organisms. This resistance is not detected by routine susceptibility testing.
Resistance to clindamycin is often associated with resistance to erythromycin.
In one multicenter, randomized, double-blind, vehicle-controlled clinical trial, subjects with mild to moderate acne vulgaris used EVOCLIN Foam or the vehicle Foam once daily for twelve weeks. Treatment response, defined as the proportion of subjects clear or almost clear, based on the Investigator Static Global Assessment (ISGA), and the mean percent reductions in lesion counts at the end of treatment in this study are shown in Table 2.
Table 2: Efficacy Results at Week 12
|Efficacy Parameters||EVOCLIN Foam
|Treatment response (ISGA)||31%||18%*|
|Percent reduction in lesion counts|
Last reviewed on RxList: 2/9/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Evoclin Information
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