Medesthetics

SEP 2014

MedEsthetics magazines offers business education and in-depth coverage of the latest noninvasive cosmetic procedures for physicians and practice managers working in the medical aesthetics industry.

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medestheticsmagazine.com | SEPTEMBER 2014 75 ultrasound sonotrode module, called IMPACT, to further enhance penetration of topical active agents through laser or RF microchannels. "The IMPACT yields exceptional results with only a few days of downtime," Dr. Alexiades-Armenakas says. "It is a perfect protocol." Dr. Waibel uses TED to deliver retinols, growth factors and antioxidants into patients' skin. "You can deliver intradermal microdroplet neuromodulators for oily skin and dilated pores, and HA (hyualuronic acid) to tough areas like upper lips and crow's feet. You can deliver Rogaine to the scalp and PRP (platelet-rich plasma) anywhere." In addition, she lists the following actives, which have been the subject of studies where they were used in conjunction with fractional lasers: • Corticosteroids and 5-fl uorouracil to treat scars • Bimatoprost (Allergan) for repigmentation • Levulan (aminolevulinic acid, DUSA Pharmaceu- ticals) and vitamin C for wound healing • Poly-L-lactic acid and hyaluronic acid for cosmetic effect. Dr. Waibel is currently conducting research that involves combining the application of fat stem cells, autologous stem cells and allogeneic stem cells with fractional laser treatments, but she does not consider these procedures ready for use on patients. THE NEXT STEP "What I would like is a system that would allow me to deliver skin lightening ingredients without the risk of infl ammation," says Dr. Bucay. "That would prob- ably require some kind of time-release delivery." According to a group of researchers in Shanghai, China, dissolving or biodegradable microneedles may be just what the doctor ordered. Their article in the September 2013 issue of Drug Design Development and Therapy says more study is needed, but they predict a bright future for dissolving microneedles for sustained delivery of drugs and vaccines. This technology could certainly be adapted to deliver skin lightening agents and other cosmetic preparations. Linda W. Lewis is a contributing editor of MedEsthetics. Dr. Waibel uses TED to deliver retinols, growth factors and antioxidants into patients' skin. BREAKING THE BARRIER Over-the-Counter Drugs Over-the-counter drugs are defi ned by the FDA as drugs that are safe and effective for use by the general public without seeking treatment by a healthcare professional. There are more than 300,000 over-the-counter drugs being marketed in the U.S. today. The FDA reviews the active ingredients and the labeling of more than 80 therapeutic classes of drugs, such as analgesics or antac- ids, instead of the individual drug products. For each category, an over-the-counter drug mono- graph is prepared and published in the Federal Register. These monographs outline acceptable ingredients, doses, formulations and labeling, and can be found in section 300 of the Code of Federal Regulations. The Offi ce of Drug Evaluation IV, under the Center for Drug Evaluation and Research, is primarily responsible for re- viewing over-the-counter drugs. Additionally, the Non- prescription Drug Advisory Committee meets regularly to help the agency in evaluating issues surrounding these products. The FDA has cited this committee as playing a major role in the growth of prescription to over-the- counter switches in recent years. Once a fi nal monograph is in place, companies can make and market an over-the-counter product without the need for FDA pre-approval. These monographs defi ne the safety, effectiveness and labeling of all mar- keted active ingredients. New drugs that don't meet an existing monograph must go through the New Drug Application process. In an industry where the "off-label" use of FDA- approved products is widespread, Anisfeld stresses the importance of understanding both the FDA approval process for drugs and devices, and the ease with which indicated uses can be identifi ed. "It's very tempting for a salesperson to try to stretch the use of a product be- yond its approved indications," he says. "But that means the doctor is taking full personal and legal responsibil- ity for anything that happens to the patient. Ask the salesperson if the product is approved by the FDA for this indication. The accepted uses also are listed on the package insert." Annemarie Mannion is a Chicago-based freelance writer. SAFE & EFFECTIVE New drugs that don't meet an existing monograph must go through the New Drug Application process. continued from page 56 continued from page 50

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