FDA ISSUES WARNING ABOUT USE OF CERTAIN ACNE TREATMENTS

In June, the FDA issued a Drug Safety Communication (DSC) to inform consumers and health care professionals that the use of certain over-the-counter, topical acne products containing the active ingredients benzoyl peroxide or salicylic acid can cause rare but serious and potentially life-threatening allergic reactions or severe irritation.

The warning indicates that serious allergic reactions differ from the less harmful irritations already included in the product Drug Facts labels, which include burning, dryness, itching, peeling, redness, and slight swelling where the product is applied.

“There is currently no mention of the possibility of these very severe allergic reactions on the product labels,” says Mona Khurana, MD, a medical officer at FDA. “It's important that consumers know about them, and that they know what to do if they occur.”

From 1969 through January 28, 2013, FDA received 131 reports from both consumers and manufacturers of allergic and hypersensitivity-related adverse reactions associated with these products. About 42 percent of these reactions occurred within minutes to 24 hours of use. The affected persons ranged in age from 11-78 years. Forty percent of these reports described severe allergy symptoms such as throat tightness, shortness of breath, wheezing, low blood pressure, fainting or collapse. Isolated instances of hives, itching of face or body (even of parts of the body where the person did not apply the medication), and swelling of eyes, face and lips were also reported.

Based on the information reported, the FDA reported that it cannot determine if these reactions were triggered by the products' active ingredients, the inactive ingredients, or a combination of both.

While no deaths have been reported, 44 percent of the cases required hospitalization.

“FDA will continue to monitor closely and evaluate this safety issue,” Dr. Khurana says. The agency is also encouraging manufacturers to use the drug label to advise consumers how to test the product's safety before using it for the first time.

For more information about this, visit http://www.fda. gov/ForConsumers/ConsumerUpdates/default.htm.

ASSESSING THE COSTS OF ORAL ANTIBIOTIC USE TO TREAT ACNE

While the average duration of oral antibiotic therapy for acne has not been widely studied, recent guidelines suggest it should be limited to three to six month months. A recent retrospective cohort study from the MarketScan Commercial Claims and Encounters database was conducted to compare the duration of oral antibiotic use with recent guidelines to determine the potential cost-savings related to shortened durations. Claims data were used to determine duration and costs of antibiotic therapy.

The study found that the mean course duration was 129 days. The majority (93 percent) of courses were less than nine months. Among the 31,634 courses, 18,280 (57.8 percent) did not include concomitant topical retinoid therapy. The mean (95 percent confidence interval) duration with and without topical retinoid use was 133 (131.5-134.7) days and 127 (125.4- 127.9) days, respectively. The mean excess direct cost of antibiotic treatment for longer than 6 months was $580.99/person.

The study authors concluded that the duration of antibiotic use is decreasing when compared with previous data, but noted there is still an opportunity for reduced antibiotic use, as it was found that 5,547 (17.53 percent) courses exceeded 6 months. “If courses greater than 6 months were shortened to 6 months, savings would be $580.99/person,” the authors concluded.

—Lee YH, Liu F, Thiboutot DM, Leslie DL, Kirby JS.
A retrospective analysis of the duration of oral antibiotic therapy for the treatment of acne among adolescents: Investigating practice gaps and potential cost-savings.
J Am Acad Dermatol. 2014;71:70-76.

ACNE CURE ALLIANCE TO OPEN TREATMENT CENTER; SEEKS MEDICAL DIRECTOR

The Acne Cure Alliance, a non-profit foundation, is focused on treating acne patients with a personalized and complementary approach to health and wellness of the skin by incorporating a customized regimen of the most current and innovative treatments, including diet modification, psychological counseling, and alternative medicine. A new center dedicated to the treatment of acne, founded by the Acne Cure Alliance, will be established within the Morristown Medical Center for Well Being in Morristown, NJ. It will offer a new and unique integrative practice approach for acne patients.

The Acne Cure Alliance is accepting applications for a Medical Director, an opportunity for a board-certified dermatologist to join the Board of Directors of the Acne Cure Alliance. For more information, email info@acnecurealliance.org.

STUDY DEMONSTRATES EFFECTIVENESS OF ACNE SYSTEM

A new study in the June issue of the Journal of Drugs in Dermatology (JDD) showed the superior efficacy the ClarityMD acne system, according to manufacturer Envy Medical, Inc. Designed by Envy Medical, the clinical study proves that ClarityMD is effective in quickly and gently clearing both inflammatory and non-inflammatory acne within days.

The two-step ClarityMD system combines salicylic acid, bakuchiol, and bisabolol in a Deep Pore Cleanser and Clarifying Gel to treat acne in two steps. It also contains anti-aging ingredients and exfoliants.

Conducted by an independent group of researchers, the study results indicate that, on average, 59 percent of acne in subjects was cleared in the first seven days, with 91.6 percent acne eradication achieved in 14 days. Participants' skin had virtually complete acne clearance of 98.5 percent over the six-week study. In addition, according to the company, redness or irritation that study volunteers were experiencing from their acne prior to starting the study dissipated within 14 days. Also, more than 56 percent reduction of non-inflammatory acne was demonstrated over the six-week period.

According to Ashish C. Bhatia, MD, FAAD, the lead author of the study and Medical Director for Dermatologic Research at the DuPage Medical Group in Naperville, IL, “This all adds up to a highly effective new tool for treating acne, that also meets the demands of adult acne sufferers who want a skincare regimen that will clear and prevent acne while actually improving the tone and texture of skin.”

IS CLINICAL ERYTHEMA ASSESSMENT SCALE RELIABLE IN EVALUATING EFFECTIVENESS OF ROSACEA TREATMENTS?

Facial erythema assessments are a common endpoint in rosacea clinical trials, but researchers who noted that the reliability of these assessments have not been evaluated, conducted a study to evaluate the inter- and intrarater reliability of the Clinician's Erythema Assessment (CEA), a 5-point grading scale of facial erythema severity. Twelve board-certified dermatologists, previously trained on use of the scale, rated erythema of 28 rosacea subjects twice on the same day. Interrater and intrarater agreement was assessed with the intraclass correlation and κstatistic.

The results of this study found that the CEA had high interrater reliability and good intrarater reliability with an overall intraclass correlation coefficient (ICC) for session 1 and session 2 of 0.601 and 0.576, respectively. The overall weighted κ statistic for session 1 and session 2 was 0.692, according to the study results.

Noting that the study was limited because raters were experienced dermatologists and there may be a risk of recall bias, the researchers concluded, “When used by trained raters, CEA is a reliable scale for measuring the facial erythema of rosacea.”

—Tan J, Liu H, Leyden JJ, Leoni MJ. Reliability of Clinician Erythema Assessment grading scale. J Am Acad Dermatol.
2014 Jul 3. [Epub ahead of print]

NEW TREATMENT OPTIONS MAY HELP MITIGATE PSYCHOLOGICAL IMPACT OF ROSACEA

A study published in the Journal of the American Academy of Dermatology found that patients with rosacea have higher incidences of embarrassment, social anxiety, depression, and decreased QoL compared with the rest of the population. Adequate treatment of symptoms results in improvement of QoL in patients with rosacea. New options that target the facial erythema of rosacea may help mitigate the negative psychological impact of rosacea.

These findings were based on a review of current treatment options as well as a review of the current literature to determine the degree of psychosocial impact of rosacea and the importance of treatment. A search of the MEDLINE, EMBASE, and psycINFO databases from 1946 to present to identify previous articles regarding the psychosocial and quality-of-life (QoL) impact of rosacea found 17 studies that focused on the following areas: impact of disease on QoL, improvement of QoL with treatment, and willingness to pay.

—Moustafa F, Lewallen RS, Feldman SR.
The psychological impact of rosacea and the influence of current management options. J Am Acad Dermatol. 2014
Jun 30. [Epub ahead of print]