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Doi:10.1016/s0037-6337(08)70489-3

Aesthetic Dermatology
S K I N & A L L E R G Y N E W S • J u l y 2 0 0 8 Photo at left
shows a patient
before treatment /
with the OLDG ENTER
photopneumatic
device. Photo at ICHAEL
right shows . M
improvement of
the patient’s acne
B Y S H A R O N W O R C E S T E R
after receiving TESTY LINICALC
four treatments OURCS
over an interval OT
K I S S I M M E E , F L A . — Photopneumatic of 3 weeks. HO ENNESSEE
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
laser system—which combines light en-ergy and a vacuum apparatus to cleansepores and destroy bacteria associatedwith acne vulgaris—was used to treatboth pustular and comedonal acne in anopen-label study involving 11 patientswith mild to moderate acne, Dr. Goldsaid at the annual meeting of the Amer-ican Society for Laser Medicine andSurgery.
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 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 Extina® (ketoconazole) Foam, 2% is indicated for Pediatric Use
the topical treatment of seborrheic dermatitis Table 1: Adverse Reactions Reported
The safety and effectiveness of Extina Foam in Reported pain
in immunocompetent patients 12 years of age by >1% Subjects in Clinical Trials
pediatric patients less than 12 years of age have and older. Safety and efficacy of Extina Foam for was minimal in
Extina Foam
Vehicle Foam
treatment of fungal infections have not been Reactions
Of the 672 subjects treated with Extina Foam in the more than 85%
clinical trials, 44 (7%) were from 12 to 17 years of Subjects with an
188 (28%)
122 (25%)
Adverse Reaction
CONTRAINDICATIONS
of patients, and
Geriatric Use
82% of patients
Of the 672 subjects treated with Extina Foam in the WARNINGS AND PRECAUTIONS
clinical trials, 107 (16%) were 65 years and over.
said they were
Contact Sensitization
Extina Foam may result in contact sensitization, Application site reactions that were reported in NONCLINICAL TOXICOLOGY
moderately or
including photoallergenicity. [See Adverse Reactions, <1% of subjects were dryness, erythema, irritation, Carcinogenesis, Mutagenesis, and Impairment
paresthesia, pruritus, rash and warmth.
of Fertility
very satisfied
Flammable Contents
Dermal Safety Studies
Long-term animal studies have not been performed 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 outcomes.
flame and/or smoking during and immediately the irradiated and non-irradiated sites treated In oral carcinogenicity studies in mice (18-months) 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 incinerate the containers. Do not expose containers 80 mg/kg/day ketoconazole was not carcinogenic. to heat and/or store at temperatures above 120°F The high dose in these studies was approximately USE IN SPECIFIC POPULATIONS
2.4 to 4.8 times the expected topical dose in Pregnancy
than 85% of patients, and 82% of patients Systemic Effects
Teratogenic Effects, Pregnancy Category C:
humans based on a mg/m2 comparison. In a said they were moderately or very satisfied Hepatitis has been seen with orally administered bacterial reverse mutation assay, ketoconazole Ketoconazole has been shown to be teratogenic ketoconazole (1:10,000 reported incidence). did not express any mutagenic potential. In three (syndactylia and oligodactylia) in the rat when in vivo assays (sister chromatid exchange in given orally in the diet at 80 mg/kg/day (4.8 corticosteroid serum levels have been seen with humans, dominant lethal and micronucleus tests in times the maximum expected human topical dose aged with application of a daily moistur- high doses of orally administered ketoconazole. mice), ketoconazole did not exhibit any genotoxic based on a mg/m2 comparison, assuming 100% These effects have not been seen with topical absorption from 8 g of foam). However, these effects may be partly related to maternal toxicity, At oral dose levels of 75 mg/kg/day (4.5 times 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
ketoconazole impaired reproductive performance Adverse Reactions in Clinical Trials
and fertility when administered to male rats 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 mobility and decreased pregnancy in mated in the clinical trials of a drug cannot be directly and well-controlled studies of Extina Foam in compared to rates in the clinical trials of another drug, and may not reflect the rates observed in Manufactured for Stiefel Laboratories, Inc.
Extina Foam should be used during pregnancy only 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 Extina and Stiefel are registered trademarks, owned this device—which is the only device that identifying the adverse reactions that appear to be Nursing Mothers
related to drug use and for approximating rates.
It is not known whether Extina Foam administered The safety data presented in Table 1 (below) reflect topically could result in sufficient systemic exposure to Extina Foam in 672 subjects, 12 years absorption to produce detectable quantities in 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 traditionaltherapies—is a welcome addition to theacne treatment armamentarium, he con-cluded.
Corp., which provided equipment, dis-counts, travel expenses, a research grant,and honoraria to Dr. Gold.

Source: http://bioskin.com.sg/biop2x/Article2.pdf

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