40 Aesthetic Dermatology S KIN & ALLERGY N EWS • July 2008

Device Uses

Photo at left shows a patient Light, Vacuum

before treatment /

with the OLD G ENTER To Improve photopneumatic C device. Photo at ICHAEL

. M Acne Lesions

right shows ESEARCH R R improvement of D the patient’s acne BY SHARON WORCESTER LINICAL

after receiving C Southeast Bureau four treatments over an interval K ISSIMMEE, FLA. — Photopneumatic HOTOS COURTESTY ENNESSEE

of 3 weeks. P T therapy is highly effective and nearly pain- less for the treatment of acne vulgaris, ac- cording to Dr. Michael Gold. BRIEF SUMMARY OF PRESCRIBING INFORMATION The recently approved Aesthera PPx laser system—which combines light en- ergy and a vacuum apparatus to cleanse pores and destroy bacteria associated with acne vulgaris—was used to treat both pustular and comedonal acne in an open-label study involving 11 patients with mild to moderate acne, Dr. Gold said at the annual meeting of the Amer- ican Society for Laser Medicine and Surgery. Up to four treatments were provided at For topical use only applied Extina Foam or vehicle foam twice daily for human milk, caution should be exercised when 3-week intervals, and all of the patients Rx only 4 weeks to affected areas on the face, scalp, and/or Extina Foam is administered to women who are experienced significant and rapid clearing INDICATIONS AND USAGE chest. Adverse reactions occuring in >1% of subjects breastfeeding. of their lesions, he reported. ® are presented in Table 1. Extina (ketoconazole) Foam, 2% is indicated for Pediatric Use Drying and the topical treatment of seborrheic dermatitis Table 1: Adverse Reactions Reported The safety and effectiveness of Extina Foam in Reported pain flattening of in immunocompetent patients 12 years of age by >1% Subjects in Clinical Trials pediatric patients less than 12 years of age have the lesions were and older. Safety and efficacy of Extina Foam for Adverse Extina Foam Vehicle Foam not been established. was minimal in treatment of fungal infections have not been Reactions N = 672 N = 497 noted within 2 n (%) n (%) Of the 672 subjects treated with Extina Foam in the established. more than 85% days of treat- Subjects with an clinical trials, 44 (7%) were from 12 to 17 years of 188 (28%) 122 (25%) Adverse Reaction [See Clinical Studies] ment in more CONTRAINDICATIONS age. of patients, and Application site burning 67 (10%) 49 (10%) than half of the None Geriatric Use 82% of patients Application site reaction 41 (6%) 24 (5%) Of the 672 subjects treated with Extina Foam in the patients, and WARNINGS AND PRECAUTIONS clinical trials, 107 (16%) were 65 years and over. said they were most experi- Contact Sensitization enced sustained Extina Foam may result in contact sensitization, Application site reactions that were reported in NONCLINICAL TOXICOLOGY moderately or clearance at 3- [See Adverse Reactions, <1% of subjects were dryness, erythema, irritation, including photoallergenicity. Carcinogenesis, Mutagenesis, and Impairment month follow- Dermal Safety Studies] paresthesia, pruritus, rash and warmth. of Fertility very satisfied up with a 78% Dermal Safety Studies Long-term animal studies have not been performed Flammable Contents with the reduction in in- The contents of Extina Foam include alcohol and In a photoallergenicity study, 9 of 53 subjects (17%) to evaluate the carcinogenic or photo-carcinogenic propane/butane, which are flammable. Avoid fire, had reactions during the challenge period at both potential of Extina Foam. outcomes. flammatory le- flame and/or smoking during and immediately the irradiated and non-irradiated sites treated In oral carcinogenicity studies in mice (18-months) sions, and up to following application. Do not puncture and/or with Extina Foam. Extina Foam may cause contact and rats (24-months) at dose levels of 5, 20 and a 70% reduction in noninflammatory le- incinerate the containers. Do not expose containers sensitization. 80 mg/kg/day ketoconazole was not carcinogenic. sions, Dr. Gold said. to heat and/or store at temperatures above 120°F The high dose in these studies was approximately USE IN SPECIFIC POPULATIONS Reported pain was minimal in more (49°C). 2.4 to 4.8 times the expected topical dose in Pregnancy than 85% of patients, and 82% of patients humans based on a mg/m2 comparison. In a Systemic Effects Teratogenic Effects, Pregnancy Category C: said they were moderately or very satisfied bacterial reverse mutation assay, ketoconazole Hepatitis has been seen with orally administered Ketoconazole has been shown to be teratogenic with the outcomes. did not express any mutagenic potential. In three ketoconazole (1:10,000 reported incidence). (syndactylia and oligodactylia) in the rat when in vivo assays (sister chromatid exchange in Adverse events included only slight Lowered testosterone and ACTH-induced given orally in the diet at 80 mg/kg/day (4.8 humans, dominant lethal and micronucleus tests in dryness post treatment, which was man- corticosteroid serum levels have been seen with times the maximum expected human topical dose mice), ketoconazole did not exhibit any genotoxic aged with application of a daily moistur- high doses of orally administered ketoconazole. based on a mg/m2 comparison, assuming 100% potential. izer, he said. These effects have not been seen with topical absorption from 8 g of foam). However, these ketoconazole. effects may be partly related to maternal toxicity, At oral dose levels of 75 mg/kg/day (4.5 times The findings are comparable with which was also observed at this dose level. [See the expected topical human dose in mg/m2), those from other studies of this device as ADVERSE REACTIONS Pharmacokinetics] ketoconazole impaired reproductive performance reported in the literature, all of which Adverse Reactions in Clinical Trials and fertility when administered to male rats have demonstrated its efficacy for the Because clinical trials are conducted under widely No reproductive studies in animals have been (increased abnormal sperm, decreased sperm varying conditions, adverse reaction rates observed performed with Extina Foam. There are no adequate treatment of acne, said Dr. Gold of the mobility and decreased pregnancy in mated in the clinical trials of a drug cannot be directly and well-controlled studies of Extina Foam in Tennessee Clinical Research Center in females). compared to rates in the clinical trials of another pregnant women. Nashville. Manufactured for Stiefel Laboratories, Inc. drug, and may not reflect the rates observed in Extina Foam should be used during pregnancy only Given that more than one-third of der- Coral Gables, FL 33134 USA practice. The adverse reaction information from if the potential benefit justifies the potential risk to matology visits are associated with acne, clinical trials does, however, provide a basis for the fetus. Extina and Stiefel are registered trademarks, owned this device—which is the only device that identifying the adverse reactions that appear to be by Stiefel Laboratories, Inc. Nursing Mothers has been approved by the Food and Drug related to drug use and for approximating rates. It is not known whether Extina Foam administered U.S. Patent Pending Administration to treat both comedonal The safety data presented in Table 1 (below) reflect topically could result in sufficient systemic © 2008 Stiefel Laboratories, Inc. and inflammatory acne, and which ap- exposure to Extina Foam in 672 subjects, 12 years absorption to produce detectable quantities in 802650-0707 pears to be effective even in those patients and older with seborrheic dermatitis. Subjects breast milk. Because many drugs are excreted in who are nonresponders to traditional therapies—is a welcome addition to the acne treatment armamentarium, he con- cluded. The study was sponsored by Aesthera Corp., which provided equipment, dis- counts, travel expenses, a research grant, and honoraria to Dr. Gold. ■