Topicaine


Topicaine

Topicaine® is a brand of topical anesthetic used to reduce sensation, especially during hair removal. It is manufactured by ESBA Laboratories, Inc.

Contents


Product description

ESBA Laboratories produces “TOPICAINE®”, a clear, translucent, long-lasting anesthetic gel. TOPICAINE® contains Lidocaine base 4% (not the chlorhydrate), and the skin is more permeable to the base form than to the salt form. The base form is lipophilic (lipid soluble) and the stratum corneum is more permeable to those, than to hydrosoluble (water soluble) substances such as salts. This lidocane is formulated in a microemulsion system. The microemulsion consists of extremely small lipid vesicles loaded with the lidocaine. These vesicles have great affinity with the stratum corneum lipids and easily integrate and merge within it, delivering its payload to the skin. Not only that, but the lidocaine is also delivered from the continuous phase of the gel (a SOLVENT SYSTEM consisting of ethanol-glycerin-water) where the lidocaine is highly concentrated and that makes it immediately available to the skin. The gel also contains skin PERMEATION ENHANCERS (“PEs”). These are safe substances that temporarily and reversibly increase the permeability of the stratum corneum – so the drug can penetrate more easily.

TOPICAINE® is a non-prescription, OTC product and all packaging is child resistant. It is available in 3 different sizes at the following retail prices*:

  1. TOP4-010-TRC (10 Gram Tube) at $15.99 – Provides up to 10 applications to the upper lip area.
  2. TOP4-030-TRC (30 Gram/1Oz Tube) at $39.99 – Provides approximately 4-5 applications to the bikini or underarm areas, 3 applications to the full face.
  3. TOP4-113-TRC (113 Gram/ 4 Oz Tube at $79.99 – This size is the most cost-effective size for repeated use. For treatments on the back, legs or any larger areas.

TOPICAINE® also comes in 10 Gram and 30 Gram tubes in a 5% product for anorectal use.

  • Special Professional Discount Pricing of about 40% is available when purchased by the box of 6 and 12 tubes, depending on the size.


Clinical data


Friedman (2000)

Doctors Fogelman, Friedman, Levine and Ashinoff of The Dermatology Department of New York University conducted a comparative, independent study of TOPICAINE®, EMLA, and ELA-Max5 (not funded in any way by ESBA Laboratories Inc.). They found TOPICAINE® to be an effective anesthetic after 30 minutes of application, and TOPICAINE® outperformed ELA-MAX 5 and EMLA in this testing.

The study was presented by Dr. Paul Friedman at the American Society of Laser Surgery and Medicine in Reno, NV on 4/17/00. An interview with Dr. Friedman was published in the July 2000 issue of Cosmetic Surgery Times. Dr. Fogelman has also presented this study and was interviewed by Cosmetic Surgery Times in April 2001 (reprints are available upon request).

The study compared the efficacy of TOPICAINE® Gel (lidocaine base 4% in gel with microsomes and permeation enhancers), with Ela-Max 5, now called LMXS (which contains 5% lidocaine chlorhydrates in liposomes) and EMLA (which contains 2.5% lidocaine and 2.5% prilocaine) in a double-blind, placebo-controlled fashion.

The three anesthetics and a placebo were applied randomly to the volar antearm of 24 volunteers, for 30 minutes, under occlusion. After the 30 minute application time, the volunteers were tested for pain by the application of a laser as painful stimuli. The pain scores were also taken 15 minutes after that and 30 minutes after that.

The results were as follows as quoted from Dr. Friedman’s presentation tape:

  1. At the 30 minutes (post application time), just after removing the anesthetics: “TOPICAINE® and Ela-Max-5 were statistically superior to control”
  2. In the following time point, 15 minutes after the removal (45 minutes post-application: “Fifteen minutes after removal, TOPICAINE® was the superior anesthetic alone”
  3. In the following time point, 30 minutes after removal (60 minutes post-application, or 30 minutes after the 30 minute application point): “we found that TOPICAINE® and EMLA were statistically superior to Ela-Max 5”.

TOPICAINE® was at the top of efficacy, clearly in time points 2 and 3. In point one, both TOPICAINE® and Ela-Max were statistically superior to control. So if you look at these results, you can see that TOPICAINE® was the anesthetic that performed with the best efficacy overall.

This same group conducted a similar study one year prior, comparing 4 topical anesthetics (NOT TOPICAINE®) and found EMLA and Ela-Max 4% to be superior to EUTECTIC LA (now called Betacaine) and to Tetracaine gel. A corollary could be that TOPICAINE® is better than all than these as well, even though the evidence is indirect. This study was published in Dermatologic Surgery, 1999.


Lee (2003)

In addition to the New York University Dermatology Department study by Dr Fogelman et al, there is another independent study that shows the same trends. This study was first presented by Dr Min-Wei Lee at the ASLMS meeting in Anaheim, in October 2003. The study was published in Cosmetic Dermatology, Vol 16 No 4 April 2003 (35-38).

Dr Min-Wei Christine Lee (East Bay Laser & Skin Care Center; Walnut Creek, CA) evaluated the efficacy of 3 leading brands of topical anesthetics (TOPICAINE 4%, Ela-Max 5% and EMLA) and compared it to a compounded tripe anesthetic “BLT” (Benzocaine 20%, Lidocaine 6% and Tetracaine 4% in a DMSO containing vehicle). The study was done in 30 patients and the anesthetics and placebo control were randomly applied to different sites in the arm of the patients. A KTP laser at 532 nm was used to cause pain.

The “BLT” compounded product provided the lower pain scores (purple color in the bar graph); however it contains a high concentration of topical anesthetics, whose safety has not been evaluated. It is in fact, an unapproved drug. The responsibility for its use and any untoward side effects will be exclusively the prescribing doctor’s. The compounding pharmacy is only responsible for making the product at the strength and purity declared in the label (see the attached article on compounding pharmacies).

The other three topical anesthetics studied were: TOPICAINE 4%, Ela-Max 5% (now called LMX 5), EMLA without occlusion, EMLA with occlusion.

The results of this study are: Topicaine 4% outperformed the other anesthetics: at 45 minutes, the pain level with Topicaine 4% was half of that reported for the other 3; at 60 minutes, both Topicaine 4% and EMLA (under occlusion) had half of the pain scores of Ela-Max 5% and EMLA without occlusion (reprints are available upon request).


Contact information

  • 1001 Jupiter Park Drive, Suite 112, Jupiter, FL 33458
  • 1 (800) 677 9299
  • 1 (561) 746 0365
  • 1 (561) 746 9581
  • 1 (561) 746 7393
  • FAX is 1 (561) 746 9628
  • [email protected]


External links

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