The Derm Directory

Retin-A-Micro

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Clinical Pearls & Key Features:

  • When acne patients consult Dermatologists, the majority present with inflammatory acne.
  • Inflammatory acne is often treated with multiple products simultaneously.
  • While AC ZONE® Gel is indicated for the treatment of all types of acne vulgaris, in clinical trials, it performed especially well in the reduction of inflammatory acne lesions.

Commentary:

  • AC ZONE® Gel is the new, topical formulation of dapsone, the well-known dermatological agent that was previously only available in oral form and not indicated for acne.
  • AC ZONE® is the first new FDA -approved chemical entity for topical acne treatment in a decade.
  • AC ZONE® Gel is approved for use in acne patients aged 12 years and older.

Drugs » Acne: Topical

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Aczone® (dapsone)

Aczone<sup>®</sup>

How Supplied:

5% gel, 30 g

Indications and Usage:

Aczone is indicated for the treatment of acne vulgaris.

Prescribing Instructions:

Prescribing Information Instructions [PDF]

Side Effects and Contraindications:

Warnings and Precautions: Hematological effects: Oral dapsone treatment has produced dose-related hemolysis and hemolytic anemia. Individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency are more prone to hemolysis with the use of certain drugs. There was no evidence of clinically relevant hemolysis or anemia in patients treated with ACZONE Gel 5%, including patients who were G6PD deficient. Some subjects with G6PD deficiency using ACZONE Gel 5% developed laboratory changes suggestive of mild hemolysis. If signs and symptoms suggestive of hemolytic anemia occur, ACZONE Gel 5% should be discontinued. ACZONE Gel 5% should not be used in patients who are taking oral dapsone or antimalarial medications because of the potential for hemolytic reactions. Combination of ACZONE Gel 5% with trimethoprim/sulfamethoxazole (TMP/SMX) may increase the likelihood of hemolysis in patients with G6PD deficiency. Peripheral neuropathy: Peripheral neuropathy (motor loss and muscle weakness) has been reported with oral dapsone treatment. No events of peripheral neuropathy were observed in clinical trials with topical ACZONE Gel 5% treatment. Skin: Skin reactions (toxic epidermal necrolysis, erythema multiforme, morbilliform and scarlatiniform reactions, bullous and exfoliative dermatitis, erythema nodosum, and urticaria) have been reported with oral dapsone treatment. These types of skin reactions were not observed in clinical trials with topical ACZONE Gel 5% treatment. Adverse Reactions: The most common adverse reactions of ACZONE® Gel 5% (incidence ≥ 10%) are oiliness/peeling, dryness, and erythema at the application site.

Adverse Reactions

The most common adverse reactions of AC ZONE® Gel 5% (incidence ≥ 10%) are oiliness/peeling, dryness, and erythema at the application site.

Company:

Allergan, Inc
714-246-4500
www.aczone.com

References:

1. D ebol SM, Herron MJ, Nelson RD . Anti-inflammatory action of dapsone: inhibition of neutrophil adherence is associated with inhibition of chemoattractant-induced signal transduction. J Leukoc Biol. 1997;62(6):827-836.
2. D raelos ZD, Carter E, Maloney JM, et al; for United States/Canada Dapsone Gel Study Group. Two randomized studies demonstrate the efficacy and safety of dapsone gel, 5% for the treatment of acne vulgaris. J Am Acad Dermatol. 2007;56(3):439.e1-439.e10.
3. Zhu YI, Stiller MJ. Dapsone and sulfones in dermatology: overview and update. J Am Acad Dermatol. 2001;45(3):420-434.

Aczone<sup>®</sup>

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