Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
A total of 439 subjects with mild to moderate acne vulgaris were treated once daily for 12 weeks with EVOCLIN Foam.
The incidence of adverse reactions occurring in ≥1% of the subjects in clinical trials comparing EVOCLIN Foam and its vehicle is presented in Table 1.
Table 1: Adverse Reactions Occurring in ≥1% of Subjects
|Adverse Reactions||Number (%) of Subjects|
N = 439
N = 154
|Headache||12 (3%)||1 (1%)|
|Application site burning||27 (6%)||14 (9%)|
|Application site pruritus||5 (1%)||5 (3%)|
|Application site dryness||4 (1%)||5 (3%)|
|Application site reaction, not otherwise specified||3 (1%)||4 (3%)|
In a contact sensitization study, none of the 203 subjects developed evidence of allergic contact sensitization to EVOCLIN Foam.
The following adverse reactions have been identified during post approval use of EVOCLIN Foam: application site pain, application site erythema, diarrhea, urticaria, abdominal pain, hypersensitivity, rash, abdominal discomfort, nausea, seborrhea, application site rash, dizziness, pain of skin, colitis (including pseudomembranous colitis), and hemorrhagic diarrhea. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
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. Orally and parenterally administered clindamycin have been associated with severe colitis, which may end fatally.