Aczone Gel (5% Dapsone) gets FDA approval for Acne

Written by on August 22, 2005 in Aczone (Dapsone Gel 5%), Rosacea Topicals with 4 Comments

The U.S. Food and Drug Administration (FDA) has approved Aczone (dapsone) Gel, 5% for the topical treatment of acne vulgaris in patients 12 years and older.

Aczone is an aqueous topical gel containing 5% dapsone. Aczone has been shown to achieve statistically significant percent reduction in the number of acne lesions and better success rate on the Global Acne Assessment Score. Like many acne treatments, the mechanism of action of dapsone gel in treating acne vulgaris is not known.

The most common adverse events reported from controlled clinical trials include oiliness/peeling, dryness, and erythema.

Patients will need to be screened to detect if they are predisposed to one type of anemia (hemolytic anemia) because of a specific enzyme deficiency, G6PD (Glucose 6-phosphate dehydrogenase) deficiency. Safety of Aczone Gel, has not been fully evaluated in patients with G6PD deficiency. Although not observed in the clinical trials with topical dapsone, serious adverse reactions have been reported with oral use of dapsone.


Aczone has been tested as a rosacea treatment and sadly it did not outperform Metrogel 1% – see Aczone Fails to Impress for Rosacea for more information.

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About the Author

About the Author: David Pascoe started the Rosacea Support Group in October 1998. .

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4 Reader Comments

  1. Michael A Tomeo MD says:

    When can I prescribe this product ?

  2. md says:

    i have been using this product for a year prescribed to me by my dermatologist it has helped allot and it also cleans my face i use it with NeoBenz Micro Wash and together they form a great team however i also noticed i have better skin when i eat healthier and go to sleep earlier and have less stress skin looks better

  3. Jenna says:

    I have been on my third week of using this and i still have not seen results….. I dont know what to do :/
    oh and i have sensative acneic skin

  4. Chad says:

    My derm prescribed this after recently being diagnosed with early stage rosacea, hope it works!

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