Dapsone gel 5% for the treatment of acne vulgaris: safety and efficacy of long-term (1 year) treatment.
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.
Lucky
Anne W
AW
Dermatology Research Associates Inc., Cincinnati, OH 45230, USA. dermresearch@fuse.net
Maloney
J Michael
JM
Roberts
Janet
J
Taylor
Susan
S
Jones
Terry
T
Ling
Mark
M
Garrett
Steven
S
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
D000890:Anti-Infective Agents; D005782:Gels; D003622:Dapsone