title: Dapsone gel 5% for the treatment of acne vulgaris: safety and efficacy of long-term (1 year) treatment.
abstract: Dapsone gel 5%, a topical formulation of dapsone, was shown to deliver clinically effective doses of dapsone with minimal systemic absorption in 2 randomized, vehicle-controlled, 12-week studies of patients with acne vulgaris. A 12-month, open-label, long-term safety study further evaluated the safety and efficacy of dapsone gel. Patients at least 12 years of age with acne vulgaris (N = 486) applied dapsone gel twice daily for up to 12 months. Application site reactions related to treatment were reported in 8.2% of the patients and were mostly mild to moderate in severity. Common nonapplication site adverse events included headache (20%) and nasopharyngitis (15%). No significant changes in hematology or blood chemistry parameters were observed. At one month, mean reduction from baseline in inflammatory lesion counts was 30.6%. At 12 months, mean reduction from baseline was 58.2%, 19.5%, and 49.0% for inflammatory, noninflammatory, and total lesion counts, respectively, (all P=.002 compared to baseline). These results show that dapsone gel 5% is safe and effective for long-term treatment of acne vulgaris and has a rapid onset of action.
authors.affiliation: Dermatology Research Associates Inc., Cincinnati, OH 45230, USA. dermresearch@fuse.net
authors.forename: Anne W
authors.initials: AW
authors.lastname: Lucky
authors.forename: J Michael
authors.initials: JM
authors.lastname: Maloney
authors.forename: Janet
authors.initials: J
authors.lastname: Roberts
authors.forename: Susan
authors.initials: S
authors.lastname: Taylor
authors.forename: Terry
authors.initials: T
authors.lastname: Jones
authors.forename: Mark
authors.initials: M
authors.lastname: Ling
authors.forename: Steven
authors.initials: S
authors.lastname: Garrett
mesh_terms: D000152:Acne Vulgaris / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D000293:Adolescent; D000328:Adult; D000368:Aged; D000890:Anti-Infective Agents / Q000008:administration & dosage* / Q000009:adverse effects* / Q000097:blood; D002648:Child; D003622:Dapsone / Q000008:administration & dosage* / Q000009:adverse effects* / Q000097:blood; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D000890:Anti-Infective Agents; D005782:Gels; D003622:Dapsone