Topicaine

[Andrea]

On 26 December 2002, I received the following note:

</font><blockquote><font size=“1” face=“Verdana, Helvetica, sans-serif”>quote:</font><hr /><font size=“2” face=“Verdana, Helvetica, sans-serif”> 12/26/02
Dear Andrea,
We want to thank you for the honesty and usefulness of your web site. We
believe you are providing a great service to the consumer and would like to
update our product information and facts to continue being part of your
service. Esba Laboratories Inc (previously DermaScan), produces „Topicaine‰,
a clear, translucent long-lasting anesthetic gel. Below find brief
description of our product and results of a study that we believe will be of
great interest.

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
lidocaine is formulated in a drug delivery system formed by MICROVESICLES.
This are lipid micelles, like liposomes, that have great affinity with the
stratum corneum lipids. But THEY ARE MUCH SMALLER THAN LIPOSOMES, so they go
in quicker and deeper. 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 easier)

FAST AND EFFECTIVE-COMPARISON WITH OTHER PRODUCTS

A totally independent study (not funded by ESBA in any way) by the
Dermatology department of New York University , the group of Drs. Friedman,
Fogelman, Levine and Ashinoff, found it to be an effective anesthetic after
30 min of application. It worked better than EMLA and Ela-Max 5 which were
also included in this study.
This 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 to Dr
Friedman was published in the July 2000 issue of Cosmetic Surgery Times. Dr
Fogelman, presented this study too at another meeting, and Cosmetic Surgery
Times published an interview with him on April 2001.
The study that compared the efficacy of our product, Topicaine Gel
(lidocaine base 4% in gel with microsomes and permeation enhancers), with
Ela-Max 5 (which contains 5% lidocaine chlorhydrate in liposomes) and
EMLA(which contains 2.5% lidocaine and 2.5% prilocaine) in a double-blind,
placebo-controlled fashion.
The 3 anesthetics and a placebo were applied (randomly) to the volar antearm
of 24 volunteers, for 30 minutes, under occlusion. After the 30-min
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 (the quotes are from Dr Friedman‚s presentation,
on tape):

1. At the 30 minute (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 minute 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 timepoints 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 had done a similar study one year before, comparing 4
topical anesthetics (not Topicaine) and found EMLA and ELA-MAX 4% superior
to EUTECTIC LA ( now called Betacaine) and to Tetracaine gel; so a corollary
could be that Topicaine is better than all those others too (even though the
evidence is indirect). This study was published in Dermatologic Surgery,
1999.

Topicaine is available in 4 different sizes:

–Unitdose 1 gram tube (12 in a package). Total: 12 grams. Each provides 1
application to the lip plus chin areas. $19.99*

–10 gram tube (twice as much product as our competitor‚s for less. Provides
approx. 4-5 applications to the full face. $15.99*

–30 gram tube (1 OZ). Provides approx. 4-5 applications to the bikini or
underarm areas; 3 applications to the full face. $39.99*

–113 gram tube (4 OZ). Fro treatments on the back, legs or any large area.
It is the most cost effective. $79.99*

• Above prices are for individuals, but we also have special prices for
  Professionals, including discounts of about 40% when purchasing by the box
  (12 and 6 tubes depending on the size)
  Let us know if you have any further comments or questions about the
  qualities of Topicaine. The current link to our web site is
  www.esbalabs.com. We can also be reach at 650-965-0665/0208, 650-969-8310
  and by email at esba@esbalabs.com
  Thanks in advance for your consideration.
  Yours truly,
  Maria Eugenia Tuttle
  Customer Service Representative
  </font><hr /></blockquote><font size=“2” face=“Verdana, Helvetica, sans-serif”>For detail, please see:

http://www.hairfacts.com/tips/pain/topicaine.html

or visit their site at:

http://www.esbalabs.com

[Andrea]

Update form a reader:

You need to add this info as well.

http://www.fda.gov/foi/warning_letters/g5646d.htm

It appears that the company that makes Topicaine changes names often…

[Andrea]

I received the following on August 13, 2006

Dear Andrea,

ESBA Laboratories, Inc. has experienced a few changes since our last letter to you, and we would like to submit our updated information.

Our first change is that we have moved from Mountain View, California. Our new address is:

ESBA Laboratories, Inc.
1001 Jupiter Park Drive
Suite 112
Jupiter, FL 33458

Our phone numbers are as follows: 1 (800) 677 9299, 1 (561) 746 0365. 1 (561) 746 9581, 1 (561) 746 7393. The FAX number is 1 (561) 746 9628. Emails are: customer service@esbalabs.com or esba@esbalabs.com. The web site is www.esbalabs.com or www.topicaine.com.

The following product updates are as follows:

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.

See the next page for product pricing and packaging information.

TOPICAINE® is a non-prescription, OTC product and all packaging is child resistant.
It is available in 3 difference 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.

TOPICAINE®’S EFFECTIVNESS IN COMPARISON WITH OTHER MAJOR TOPICAL ANESTHETICS

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.

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).

In conclusion, we would like to tell you how much we appreciate the service you provide to consumers, and we are proud to be associated with your web site. Please don’t hesitate to contact us if you have any questions or need any further information about the qualities of TOPICAINE®.

Sincerely,

Elizabeth Snedeker
Customer Service Representative