ACZONE™ (dapsone) Gel, 5%
FOR TOPICAL USE ONLY
NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE
ACZONE™ Gel, 5%, contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. ACZONE™ Gel is a gritty, translucent material with visible drug substance particles.
ACZONE™ Gel, 5%, is indicated for the topical treatment of acne vulgaris.
Glucose 6-phosphate dehydrogenase (G6PD) levels should be obtained prior to initiating therapy with ACZONE™ Gel, 5%. In patients with a history of anemia and predisposition to increased hemolytic effect with dapsone (e.g., glucose-6-phosphate dehydrogenase deficiency), closer follow-up for blood hemoglobin levels and reticulocyte counts should be implemented (see PRECAUTIONS). Alternatively, other therapies for acne than ACZONE™ Gel, 5%, may be considered.
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Published Studies Related to Aczone (Dapsone Topical)
Erosive pustular dermatosis of the scalp: A review with a focus on dapsone therapy. [2011.11.08]
CONCLUSION: Our observations demonstrate topical dapsone 5% gel to be a novel, safe, and efficacious therapeutic alternative for mild to moderate EPDS. Copyright (c) 2011 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.
Hematologic safety of dapsone gel, 5%, for topical treatment of acne vulgaris. [2008.12]
OBJECTIVE: To evaluate the risk of hemolysis in subjects with glucose-6-phosphate dehydrogenase (G6PD) deficiency who were treated for acne vulgaris with either dapsone gel, 5% (dapsone gel), or vehicle gel... CONCLUSIONS: After treatment with dapsone gel, 5%, no clinical or laboratory evidence of drug-induced hemolytic anemia was noted in G6PD-deficient subjects with acne vulgaris. Trial Registration clinicaltrials.gov Identifier: NCT00243542.
Efficacy and safety of dapsone gel 5% for the treatment of acne vulgaris in adolescents. [2008.02]
Two 12-week, randomized, vehicle-controlled... Results from the large number of adolescent participants in these 3 studies show that dapsone gel is an effective and safe topical therapy for the treatment of acne vulgaris in adolescents aged 12 to 15 years for up to 12 months.
Dapsone gel 5% for the treatment of acne vulgaris: safety and efficacy of long-term (1 year) treatment. [2007.10]
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... 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.
Two randomized studies demonstrate the efficacy and safety of dapsone gel, 5% for the treatment of acne vulgaris. [2007.03]
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... CONCLUSIONS: Dapsone gel, 5% appears to be an effective, safe, and well-tolerated treatment for acne vulgaris, with a rapid onset of action.
Clinical Trials Related to Aczone (Dapsone Topical)
A Phase II, Randomized Study of ACZONEâ¢ (Dapsone) Gel, 5% for Papulopustular Rosacea. [Completed]
The purpose of this study is to evaluate the safety and effectiveness of ACZONE™ gel compared
to placebo (inactive substance), MetroGel® and a combination of ACZONE™ gel and MetroGel® for
the treatment of rosacea.
ACZONE™ gel, 5% is a topical (applied to the skin) medication that is approved by the United
States Food and Drug Administration (FDA) for the treatment of acne vulgaris in people 12
years and older. The use of ACZONE™ for the treatment of rosacea is investigational. An
investigational use is one that is not approved by the FDA.
Subjects will apply the study treatment for 12 weeks. Efficacy assessments will be performed
at baseline and Weeks 2, 4, 8, and 12. Laboratory assessments will be conducted at baseline
and Week, 2, 4 and 12.
A Phase II Study of ACZONEâ¢ (Dapsone) Gel, 5% As a Treatment For Tarceva® (Erlotinib)Related Rash [Terminated]
The purpose of this study is to evaluate the safety and preliminary efficacy of ACZONE in
subjects treated with the HER1/EGFR inhibitor Tarceva (erlotinib) who develop a rash on the
Safety, Tolerability, and Pharmacokinetics of Dapsone in Acne Vulgaris [Recruiting]
This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of dapsone in
subjects with acne vulgaris following 28 days of dosing.
Pharmacokinetics Study of Dapsone-Adapalene Fixed Combination Gel in Acne [Not yet recruiting]
This study will investigate the pharmacokinetics, safety and tolerability of dapsone and
adapalene following topical administration of 2 formulations of dapsone/adapalene fixed
combination gel, dapsone 5% gel (ACZONE®), and adapalene 0. 3% gel (Differin®) in subjects
with acne vulgaris.
An Extension Study to Assess the Safety, Tolerability, Efficacy, and Treatment Adherence of Dapsone in Acne Vulgaris [Not yet recruiting]
This study will assess the safety, tolerability, and efficacy of dapsone in subjects with
acne vulgaris following 12 weeks of treatment.
Reports of Suspected Aczone (Dapsone Topical) Side Effects
Drug Ineffective (17),
Completed Suicide (4),
LIP Swelling (2),
Expired Drug Administered (2),
Hypoaesthesia Oral (2),
Oedema Peripheral (2),
Swelling Face (2), more >>
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 1 ratings/reviews, Aczone has an overall score of 8. The effectiveness score is 8 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
Aczone review by 48 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Considerably Effective|
|Side effects:|| || Mild Side Effects|
|Condition / reason:|| || acne|
|Dosage & duration:|| || 5% (dosage frequency: twice a day) for the period of three months so far|
|Other conditions:|| || possible mild rosacea|
|Other drugs taken:|| || none|
|Benefits:|| || improve cystic acne on chin -- I still get a few bumps but not as many or as violent as before the treatment.|
|Side effects:|| || perhaps a little dryness but I cannot say that this was a problem at all.|
|Comments:|| || I have tried many prescription and nonprescription medications for adult acne. This one worked as well as any of them with less irritation. While I was using the medication to treat cystic acne I also saw a significant improvement is white heads and black heads. White heads on my forehead virtually disappeared. |
Page last updated: 2014-11-25