WARNING LETTER

The FDA has reviewed a journal advertisement (APC021052008) for ACZONE® (dapsone) Gel, 5% (ACZONE) (and) this journal advertisement is false or misleading because it grossly overstates the efficacy of ACZONE, and omits material facts and important risk information associated with the use of the product.

The offending advertising claims.

The journal article overstates the effectiveness of Aczone by neglecting to state that at 2 weeks usage, Aczone was only 2% more effective than the placebo vehicle gel. This small difference is not considered statistically significant so it not a true claim of efficacy. The 12 week trial results were also over stated by ignoring the comparative effect of the vehicle gel.

The second part of the warning deals with the omission of important risk information associated with Aczone. Clinical trials found that 7 out of 95 subjects who applied benzoyl peroxide after applying Aczone had yellow or orange discoloration of the skin and facial hair. This discoloration took between 4 and 57 days to resolve.

The FDA attracts a lot of criticism from rosacea sufferers who see the organisation as overly bureaucratic and unnecessarily slowing down new drug applications. We do need a policeman to help protect us from cynical vendors who make claims that are not based on proven facts. Personally I’m glad that the FDA is willing to publicise vendors who try to take advantage of rosacea sufferers.

An important message here is that rosacea sufferers would be wise to be wary of statistical claims in advertising materials. Seek out published proof before believe what you read.

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From: Allergan Announces Agreement to Acquire Aczone(R) Gel 5%

“Aczone(R) Gel 5% is the first new chemical entity approved by the FDA for the treatment of acne in several years, and represents an important clinical advance in dermatology with a robust safety and efficacy profile demonstrated in more than 3,000 patients,” said Scott Whitcup, M.D., Allergan’s Executive Vice President of Research and Development. “We are excited to make Aczone(R) Gel 5% widely available to dermatologists and their patients in North America, underscoring our commitment to continue to invest and respond to unmet medical needs in dermatologic therapies and building upon our more than 10 years of success with TAZORAC(R).”

Aczone is 5% topical dapsone gel. Originally targeted as an acne treatment, it has also been trialled as a rosacea treatment. Aczone is contraindicated for anyone with a history of anemia or an enzyme deficiency.

The new owners of Aczone are Allergan who perhaps are better known for making the dry eye treatment Restasis, Refresh artificial tears, and the product that was the genesis of Sansrosa – Alphagan P.

I am yet to see any results from the trials for treating rosacea with Aczone. It will be interesting to see if Allergan has plans to broaden the marketing of Aczone to include rosacea.

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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

The study was hoping for 400 participants at 27 centres and was scheduled to start in November 2005, and complete in November 2006.

Contact information for each center is available at the ClinicalTrials.gov website.

The manufacturers of Aczone, QLT, mention the following at their website ;

QLT recently re-acquired full worldwide marketing rights for Aczone. The product was approved by the FDA, with a label restriction, in mid-2005. We are proceeding with a Phase IV post-approval trial with a goal to have the restriction removed. The trial began in the fourth quarter of 2005.

Aczone is also being investigated for its potential in the treatment of rosacea. A Phase II study began in the fourth quarter of 2005 to evaluate the product’s safety and efficacy in humans.

• Clinical Trial Info
• Aczone Package Insert

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• aczone gel (5% dapsone) gets FDA approval for acne
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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.

See also

• Aczone Package Insert.

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