ACZONE SUMMARY
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.
|
NEWS HIGHLIGHTSMedia Articles Related to Aczone (Dapsone Topical)
Health Tip: What's Triggering My Acne?
Source: MedicineNet Acne Specialty [2009.06.24]
Title: Health Tip: What's Triggering My Acne?
Category: Health News
Created: 6/24/2009 7:00:00 AM
Last Editorial Review: 6/24/2009
New Laser Combo Therapy Zaps Acne
Source: MedicineNet Acne Specialty [2009.03.09]
Title: New Laser Combo Therapy Zaps Acne
Category: Health News
Created: 3/7/2009 2:00:00 AM
Last Editorial Review: 3/9/2009
Acne Cream Not Linked to Raised Death Risk
Source: MedicineNet tretinoin Specialty [2009.01.26]
Title: Acne Cream Not Linked to Raised Death Risk
Category: Health News
Created: 1/24/2009 2:00:00 AM
Last Editorial Review: 1/26/2009
FDA OKs New Acne Gel Epiduo
Source: MedicineNet adapalene Specialty [2009.01.07]
Title: FDA OKs New Acne Gel Epiduo
Category: Health News
Created: 1/7/2009
Last Editorial Review: 1/7/2009
Acne (Pimples)
Source: MedicineNet Boils Specialty [2008.07.16]
Title: Acne (Pimples)
Category: Diseases and Conditions
Created: 12/31/1997
Last Editorial Review: 7/16/2008
Published Studies Related to Aczone (Dapsone Topical)
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.
A double-blind study on the efficacy of oral dapsone in cutaneous leishmaniasis. [1991.03]
One hundred and twenty patients with localized cutaneous leishmaniasis were randomly allocated to receive tablets of dapsone (100 mg) or matching placebo tablets every 12 h for 6 weeks. No topical medication was used... Oral dapsone has certain advantages over other current forms of treatment: it is economical and widely available in countries where cutaneous leishmaniasis is common, and it is effective by mouth and well tolerated.
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 ACZONEâ„¢ gel compared
to placebo (inactive substance), MetroGel® and a combination of ACZONE™ gel and MetroGel® for
the treatment of rosacea.
ACZONEâ„¢ 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 ACZONEâ„¢ 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
face
Chlorproguanil-Dapsone-Artesunate (CDA) Versus Chlorproguanil-Dapsone (LAPDAP) For Uncomplicated Malaria [Completed]
CDA is a combination of chlorproguanil, dapsone and artesunate, being developed in a
public-private partnership with the Medicines for Malaria Venture (MMV), World Health
Organisation (WHO-TDR) and academic partners from the London School of Hygiene and Tropical
Medicine, University of Liverpool and the Liverpool School of Tropical Medicine as a
treatment for acute uncomplicated P. falciparum malaria.
The combination of chlorproguanil HCl (CPG) and dapsone (DDS) as chlorproguanil-dapsone has
already been shown to be efficacious against P. falciparum in adults and children in
Sub-Sahara Africa. The addition of artesunate to LAPDAP has been demonstrated to increase
the parasite kill rate as demonstrated in the phase II study, and reduce the chance of any
parasites escaping treatment over the 3-day course. The addition of artesunate is also
anticipated to have the population benefit of protection against the development of resistant
strains of P. falciparum, although it will not be possible to demonstrate this in a clinical
trial. One further population benefit of the artemisinin drugs are their ability to suppress
the sexual forms of the parasite (gametocytes), which should reduce infectivity after
antimalarial treatment and potentially lower transmission rates with widespread use,
including the spread of any parasites resistant to the partner drug.
The aims of this phase III study are to compare the efficacy of a fixed ratio combination
tablet of CDA to chlorproguanil-dapsone, and collect supporting safety data. This will be a
multi-centre, double-blind, double-dummy, randomised trial, in children, adolescents and
adults, with chlorproguanil-dapsone as a comparator.
Phase IV Study to Gather More Information About the Safety of ACZONE Gel, 5% in Treating Subjects With Acne Who Have G6PD Deficiency. [Completed]
The purpose of this study is to gather more information about the safety of ACZONE Gel, 5% in
treating subjects with acne who have certain blood disorders.
ACZONE Gel, 5% is a prescription skin use (topical) medicine used to help treat acne in
people 12 years and older. ACZONE Gel, 5% has been studied in approximately 4000 people and
was shown to reduce the number of pimples and improve acne.
The active drug ingredient in ACZONE Gel, 5% is dapsone. People with blood disorders called
"G6PD deficiency", "methemoglobin reductase deficiency", and "hemoglobin M" have a higher
chance of side effects with dapsone.
G6PD is short for "glucose-6-phosphate dehydrogenase". It is an enzyme found in red blood
cells, which carry oxygen to all parts of the body. G6PD helps the red blood cells to
function normally. Some people have less G6PD in their red blood cells than the average
person. This is called G6PD deficiency.
Two treatments - ACZONE Gel, 5% and placebo - will be studied for comparison.
A Phase 3 Study to Compare the Safety and Efficacy of 5% Dapsone Topical Gel, (DTG) Twice Daily in Combination With Once Daily Vehicle Control, Adapalene Gel 0.1% or Benzoyl Peroxide Gel 4%. [Completed]
The purpose of this study is to compare the safety and efficacy of 5% Dapsone Topical Gel,
(DTG) twice daily in combination with once daily vehicle control, adapalene gel 0. 1% or
benzoyl peroxide gel 4%. The second objective of the study is to determine dapsone exposure
after co-administration of DTG 5% with vehicle control, adapalene or benzoyl peroxide gel.
|
