29408
document
Two randomized studies demonstrate the efficacy and safety of dapsone gel , 5 % for the treatment of acne vulgaris . BACKGROUND A new aqueous gel formulation of dapsone has been developed that allows clinically-effective doses of dapsone to be administered topically with minimal systemic absorption . OBJECTIVES The goal of these studies was to evaluate the efficacy and safety of dapsone gel , 5 % in the treatment of acne . METHODS Patients 12 years of age and older with acne vulgaris ( N = 3010 ) participated in two identically-designed 12-week , randomized , double-blind studies of twice-daily monotherapy with dapsone gel , 5 % , versus a vehicle gel . RESULTS Dapsone gel-treated patients achieved superior results in terms of the investigator 's global acne assessment ( P < .001 ) and the mean percentage reduction in inflammatory , noninflammatory , and total lesion counts ( all , P < .001 ) at week 12 . Reductions in inflammatory lesion counts favoring dapsone gel over vehicle were apparent as early as 2 weeks and reached statistical significance by 4 weeks . No clinically significant changes in laboratory parameters , including hemoglobin , even among glucose-6-phosphate dehydrogenase-deficient patients , were observed . Adverse events were comparable between the treatment groups and rarely led to discontinuation . LIMITATIONS Adjunctive topical treatments and their impact on acne were not studied in this trial . CONCLUSIONS Dapsone gel , 5 % appears to be an effective , safe , and well-tolerated treatment for acne vulgaris , with a rapid onset of action .
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Intervention_Pharmacological
dapsone gel
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Intervention_Pharmacological
dapsone
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Intervention_Pharmacological
dapsone
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Intervention_Pharmacological
dapsone gel
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Intervention_Pharmacological
monotherapy with dapsone gel , 5
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Intervention_Pharmacological
vehicle gel
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Intervention_Pharmacological
Dapsone gel-treated
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Intervention_Pharmacological
dapsone gel
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Intervention_Pharmacological
Dapsone gel
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Outcome_Other
efficacy
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Outcome_Other
safety
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Outcome_Other
efficacy
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Outcome_Other
safety
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Outcome_Physical
reduction in inflammatory , noninflammatory , and total lesion counts
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Outcome_Physical
inflammatory lesion counts
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Outcome_Physical
hemoglobin
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Outcome_Adverse-effects
Adverse events
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Outcome_Physical
acne vulgaris
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Participant_Condition
acne vulgaris
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Participant_Age
Patients 12 years of age and older
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Participant_Condition
acne vulgaris
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Participant_Sample-size
N = 3010