Aesthetic Lasers and Energy Devices Market in the US to Grow at a CAGR of 11.58% During the Period 2016 – 2020; Finds New Report

Background
Clinicians are increasingly using topical anesthetics (“numbing creams”) to decrease the pain associated with minimally invasive dermatologic, aesthetic, needle insertion, cannulation and laser procedures (among others).
Numerous lidocaine-containing products are available, but comprehensive studies are lacking regarding their relative safety and appropriate dermatologic uses.

  • Understanding the basics:
  • Mechanism of Action
  • Safety and Efficacy
  • Proper Application
  • Clinical Uses
  • Risk Factors
  • Mitigation of Risks

General Concept:

Lidocaine-containing products play an integral role in cutaneous anesthesia by
providing patient comfort with minimal side-effects. Careful attention should be paid to the particular anatomic location, the total surface area covered, the concentration of anesthetic ingredient(s), mechanisms of action of additional pharmacologic ingredients and the duration of anesthetic skin contact.

Awareness:

Topical anesthetics decrease pain during superficial cutaneous procedures. As the number of in-office dermatologic procedures continues to grow, clinicians will benefit from awareness of the indications, pharmacologic mechanisms, appropriate methods of application, and safety profiles of the currently available prescription and over-the-counter (OTC) topical anesthetics.

Mechanism of Action:

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Once inside the dermis, ester and amide anesthetics possess the same mechanism of action. The anesthetic binds the voltage-gated sodium ion channel of the free nerve endings and blocks sodium influx. The blockade of sodium influx inhibits nerve cell depolarization and prevents propagation of nerve cell impulses along the nerve. Meechan JG. Intraoral topical anesthesia. Periodontal 2000 2008;46:6 – 79

Clinical Use and Application:

Application of a topical anesthetic before superficial dermal instrumentation procedures can help to relieve pain and anxiety related to anticipated pain. Patients can apply the topical anesthetic before arriving at the office, assuming they have proper instructions on its safe application.

Safe application involves gently washing the area to be treated with a mild cleanser and water to eliminate contaminants (e.g., makeup, dirt) that could hinder the absorption or efficacy of the anesthetic. The product should be applied in a thin
layer (approximately 1/8”) and at an approximate volume of 0.75 – 2.0 milliliters per 1”x1” square (for 4% – 5% concentrated topical lidocaine creams or gels). The volume will be determined based on factors such as: location, skin type, level of procedural aggressiveness, known pain tolerance of patient and known patient sensitivity to active ingredient.

Depending upon the anesthetic used, the product is left in place for 20 to 60 minutes. Occlusion with plastic wrap or massaging the cream into the skin (or both)
may achieve quicker onset of action, if necessary. Immediately preceding the procedure, the material is removed with dry gauze, and the skin is wiped clean with water-dampened gauze or normal preparation procedures.

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Topical anesthetics are routinely used for (among others) the following procedures:

  • Laser hair and tattoo removal
  • Cosmetic injectables
  • Ablative skin resurfacing treatments
  • Chemical peel
  • Micro-needle
  • Dermabrasion
  • Superficial mole and carcinoma excision
  • Injections
  • Veni-puncture
  • Other superficial dermal instrumentation procedures as directed by a license physician

Potential for Complications:

Improper application of topical anesthetic preparations such as benzocaine, lidocaine, prilocaine and tetracaine may cause serious complications. Complications can come in two primary forms: central nervous system toxicity and cardio-toxicity. Complications can be caused by prolonged application, use of
inappropriately high concentrations (20% – 30% BLT as one of many examples), and application to overly large surface areas.

Adverse Events Warning Signs:

There is some degree of inherent risk associated with the use (and more appropriately misuse) of topical anesthetics. In general, the central nervous system is more susceptible to the pharmacologic actions of local anesthetics than is the cardiovascular system. Wagman IH, De Jong RH, Prince DA. Effects of lidocaine on the central nervous system. Anesthesiology 1967;28:155 – 72

The initial symptoms of anesthetic-induced toxicity include (among others) lightheadedness, circumoral numbness, diplopia, slurred speech, fine tremors and tinnitus.
Many adverse reactions also appear to be related to the inclusion of epinephrine within the anesthetic mixture. Mehra P, Caiazzo A, Maloney P. Lidocaine toxicity. Anesth Prog 1998;45:38 – 41

Application Tips:

In an effort to reduce the risks (and improve efficacy) associated with the application of topical anesthetics, you may choose to adhere to some or all of the following suggestions:

  • Apply topical anesthetics ONLY to intact skin
  • Avoid use of inappropriately, highly concentrated anesthetics
  • Use approved or monograph complaint anesthetics whenever possible
  • Use the least amount (and active ingredient concentration) of anesthetic necessary to achieve positive results
  • Limit occlusion to only those areas most sensitive to pain
  • Limit pre-application penetration improving methods such as applying warm compresses prior to anesthetic
  • application to only the most pain sensitive cases (if at all)
  • Avoid use of amide anesthetics in patient with severe hepatic dysfunction or failure
  • Be mindful of product amount applied, total surface area covered, thickness of stratum corneum, and duration of application
  • Closely monitor patients for toxicity risk warning signs
  • Management of Toxicity:When administered with the necessary reasonable precautions, it is unlikely that you will experience severe adverse events when using appropriately concentrated topical anesthetics.

    In the unlikely event you do, rapid recognition of and quick response to anesthetic toxicity are the most important steps in managing an overdose. In the event you suspect that a patient is experiencing any of the aforementioned signs or symptoms, the topical anesthetic must be immediately washed off. The patient should be placed in a supine position and vital signs taken. If the patient has lost consciousness, maintenance of a patent airway and ventilation are a top priority. Benzodiazepines may be administered, and serum lidocaine levels should be checked. Anticonvulsants should be provided asprophylaxis or to treat seizures induced from anesthesia toxicity. Topical Anesthetics for Dermatologic Procedures: A Review JOSEPHF. SOBANKO, MD,* CHRISTOPHERJ. MILLER, MD,*ANDTINAS. ALSTER,MD

    Appropriate Precaution:

It must be emphasized to the patient that improper product use can result in serious adverse events. The U.S. Food and Drug Administration (FDA) issued a
public health advisory in 2007 reporting at least two instances of death when young women applied topical anesthesia under occlusion to their legs before laser hair removal.

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders

/DrugSafetyInformationfor HealthcareProfessionals/PublicHealthAdvisories/ucm054718.htm
The advisory recommended that patients use only FDA-approved topical anesthetics with the lowest concentration of anesthetic for the shortest amount of time necessary.

Despite a large volume of FDA warnings, a large number of pharmaceutically compounded topical anesthetics remain in use for outpatient procedures
such as laser hair removal, rejuvenation, resurfacing or other soft tissue augmentation. DA. Warns five firms to stop compounding topical anesthetic creams. Food and Drug Administration: Washington, DC, 2006

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/default.htm

Concern grew because of the presence of higher concentrations of the compounded anesthetic mixtures in comparison to FDA-approved and monograph compliant products.

It may be prudent to also be wary of medical device distributors and representatives who supply their own compounded products when demonstrating a device they are trying to sell you. You may not know how or where they procured it nor the safety standards under which it was produced.

In the event a sales representative is attempting to sell you a compounded topical anesthetic, keep in mind there are very high commissions paid on these products and the representative may not be aware (or be concerned) of the rules governing access to topical anesthetics (which happen to be fairly strict in nature). see US FDA rule Compound Quality Act.

There are strict compliance policies, both State and Federal that regulate anticipatory compounding as well as other policies regarding the manufacture, sale and use of compounded anesthetics.

High Risk Topical Anesthetics:

Compounded products, in particular, inappropriately, highly concentrated products,
present a potentially higher degree of risk than those approved or monograph complaint anesthetics.

This is primarily due to:

  • Risk of toxic levels of systemic absorption
  • Risk of mislabeling
  • Risk of improper application instructions
  • Risk of dangerous microbial matter
  • Significant variability in product quality and accurate dosing of these compounded
  • products becomes difficult because they are packaged in widely different containers.

Compounded products have a low therapeutic index and are often improperly labeled. All of these factors increase the risk of adverse events, including
overdose, seizures, arrhythmias, and death and should prompt practitioners to limit the use of topical anesthetics to those approved by the FDA or in compliance with established monograph policies. Kravitz ND. The use of compound topical anesthetics: a review. J Am Dent Assoc 2007;138:1333 – 9

Common Approved Prescription and Monograph OTC Topical Anesthetics:

EMLA® by Astra Zeneca
LMX4® by Ferndale
Pliaglis® by Galderma
Synera® by Galderma
NeuroMed7® by Sambria Pharmaceuticals

Conclusion:

Clinicians are increasingly using topical anesthetics to decrease the pain associated with superficial dermatologic, aesthetic, laser and needle insertion procedures. Lidocaine-containing products play an integral role by providing patient comfort with minimal side effects.

Risk of adverse events can be dramatically decreased when appropriately adhering to basic precautionary methods of application.

Careful selection and application of topical anesthetics can decrease or eliminate pain during many cutaneous procedures, reduce anatomic distortion by minimizing volume of intradermal local anesthesia, and decrease anxiety in patients who fear pain from procedures.

About the Author: 

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Michael Greenspan is the Founder of Sambria Pharmaceuticals, and the developer of NeuroMed7®, a topical anesthetic (numbing cream) supplied to the aesthetic and dermatology specialties (among others). NeuroMed7® is marketed by Sambria Pharmaceuticals. Follow Michael and Sambria Pharmaceuticals on LinkedIn to continue receiving notification of future articles. Send a connection request to begin networking.

How Can we manage Rosacea?

10 Aug 2015 In: Uncategorized

What is ROSACEA?
Rosacea is a long-term skin condition usually affecting the cheeks, nose and forehead. Rosacea is characterized by a tendency to flush and blush after exposure to triggers such as stress, sunlight, spicy foods and alcohol. When a person blushes, blood vessels on the face dilate – for those with rosacea this happens so often that over time, the blood vessels remain permanently enlarged. Some rosacea sufferers go on to develop inflammatory pimples. In many, the eyes are affected as well.

Types of Rosacea:
Mild – Occasional flushing, redness, small blood vessels may be seen on the nose and cheeks.
Moderate – Patches of redness persist, pimples, skin burning, stinging, visible blood vessels.
Severe – Diffused facial redness that is chronic, enlarged red bumpy nose called Rhinophyma (mostly in men), multiple bumps and or pustules,enlarged blood vessels.
Ocular – May affect half of sufferers (1), eyes red, watery, burn, gritty, red eyelids, styes

What are the Causes of Rosacea?
Genes
Environment
Unknown

Triggers – Sufferers have reported as follows:

Sun exposure (81%)
Emotional stress (79%)
Hot weather (75%)
Wind (57%)
Intense exercise (56%)
Alcohol (52%)
Spicy foods (45%)

As one ages, dealing with rosacea can become problematic as flushing of the face associated with rosacea is caused by blood vessels dilating. The repeated over-dilation, for many, will become permanent, leading to the skin becoming ruddy and the vessels enlarged, and more visible through the skin.

As with a number of other skin conditions, if you suffer from rosacea, you may find that your flare-ups are often set off or made worse by a number of triggers. By recognizing and managing these triggers, it is possible to reduce the impact on your life. With fewer flare-ups, the potential of long term damage is reduced.

Related problems:

Self conscious.
Depression.
Mistaken for high blood pressure or drinking problem.

Who is affected by Rosacea?
2 million Canadians (1)
Mainly fair skinned people.
30-50 years old.
More common in women

Potential Treatments for Rosacea:
Over the Counter and Dermatological based skin care formulated specifically for Rosacea.
Mild ph-balanced cleansers and moisturizers.
Procedures such Laser,IPL, Photo Facial therapies.

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Sources:(1) Canadian Dermatology Association
Written by Chantal Ward, RN, CANS

doctor studyingRunning a financially successful medical spa is a difficult task. Annual planning of quarterly marketing is most successful! For help in 2015 call me at 262-707-5313. I can help!

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