Dr. Pilcher--Thanks

[Guest guest]

Dr. Pilcher,

Thank you for coming here and being as open on this subject as you have

been--it is rare that a company representative will do that and this only

makes me more optimistic that this lotion is not another snake oil but

rather a new discovery that may help a significant amount of people with

ezcema and/or rosacea. Companies pitching snake oils, also, would never

give out samples ahead of launch and remeber we found out about this on the

seb derm board by someone who was given a sample months ago by the CEO.

Many of us suffer from both so if this lotion can help either of the

symptoms than we will be one step ahead of where we were yesterday.

Recently, there has been a lot of discussion on this board about how there

is such a lack of research being done on this condition so I think we are

all happy that at least one company is looking for answers to help us.

Though members of the medical field make argue about the relevancy of your

clinical studies, I for one, and perhaps many others, will not pre-judge

your product just because you did not have the funds that say a Galderma

might when they studied metrogel (metrogel, by the way,is useless for most

of us).

Where are the clinical studies on rosaceacare, vita-oil, ltd-111

discs,herbacort, a/r cream, and many of the other OTCs that many have used

with success--even more the reason to beleive that Dr. Pilcher is not

pitching a snake oil here--time will tell but the pessimism shown by some

will not get us anywhere--if everytime we shot down a company's product

without it ever being launched first just becasue their clinical data does

not meet your approval, then I can't imagine that any company would want to

do research in this field.

Again, thank you Dr. Pilcher for coming here and I look forward to putting

this lotion in my arsenal against both seb derm and rosacea--I have used

everything under the sun for my seb derm, some have worked great, and some

have been useless, put I always get excited when a new product comes out for

either condition because it makes me feel that there are doctors and

companies out there that do care and reinforces my attitude that some day we

will be cured.

RJ

>

>

> > I'm sure this is meant for the group:

> >

> > -=-=-=-=

> >

> > Hopefully I can finally put to rest the criticisms and concerns

> > voiced here regarding the manner in which our cea clinical

>study

> > results were presented. I have posted an updated version of the

>study

> > that includes data obtained from the control group as well as

> > additional graphs showing comparisons of the severity scores at the

> > beginning and end (4 weeks) in both the control and Dramatic Relief

> > treated groups. And to head certain concerns off at the pass, this

>is

> > all of the data- not just a portion of it.

> >

> > Some explanation is due. For a currently unknown reason, the

>document

> > that has been circulating (the original study document for which we

> > have been criticized) did not include the control data. Rather than

> > continue to say that indeed our study was blinded and controlled we

> > have now uploaded the document that includes this information. It

>is

> > posted in the files section of this forum under the name " Cutanix

> > cea Clinical Study " and is available for your perusal.

> >

> > The control lotion used in our study was the Dramatic Relief lotion

> > minus Quadrinone. Patients in the active group received Dramatic

> > Relief Lotion with Quadrinone (1%). I am sure there will be further

> > questions regarding this study and will be happy to address them.

> >

> > >Here's the problem I still see: even as a private communication to

>a

> > > lay person, the study said absolutely nothing about a control

>cream

> > or

> > > control subjects (and it's not easy to imagine where these would

> > fit

> > > in); it described Dr. Draelos as assessing the scores herself;

>and

> > > the scale as described sounds imperfect as a tool for assessing

> > > rosacea, much less for assessing changes in an objective manner.

> >

> > Hopefully, I have taken care of your concerns regarding control

> > subjects and control cream used in the study. Dr. Draelos did

>indeed

> > assess and score the patients herself- after all she is the

> > physician. The scale used by Dr. Draelos in this study reflects the

> > limitations of claims we can make. We are not a pharmaceutical

> > company per se in that Dramatic Relief is not to be marketed as a

> > prescription drug. It will be sold as a cosmeceutical that one can

> > purchase OTC. As such, we are unable to make specific claims about

> > CURING rosacea and are limited to claiming that Dramatic Relief

>will

> > treat symptoms associated with the disease. The parameters Dr.

> > Draelos used in her assessment directly reflect just that- 1)

> > erythema, 2) desquamation (peeling), 3) uneven skin tone, and 4)

> > dermatitis. How are her assessments less than objective? She was

> > blinded to who received control or active until after the

>completion

> > of the study.

> >

> > > I recognize these criticisms are directed at an unofficial

> > > presentation of the data. Still, I presume it was an accurate

> > > description. You must agree that, as presented to us, it is not

> > > accurate to describe Dr. Draelos' study as blinded and

>controlled.

> >

> > > I remain skeptical of company-sponsored conference presentations

> > and

> > > studies, no matter how well-credentialled the researcher may be.

>I

> > > know why most physician-researchers participate in these types of

> > > studies

> >

> > Perhaps your most troubling comment is in regards to Dr. Draelos

> > herself and to the fact that we are not performing our studies in

>an

> > independent manner. Dr. Draelos is in no way directly affiliated

>with

> > Cutanix and has not received any direct benefit from these studies

> > (cash or stock). She runs an INDEPENDENT contract clinical testing

> > service named Dermatology Consulting Services in High Point, North

> > Carolina that we decided to use for our clinical studies. To infer

> > that she has gained monetarily from some sort of under the table

> > arrangement in exchange for favorable clinical results is simply

> > ridiculous. I urge you to go to her web site and view her

>curriculum

> > vitae (http://zdraelos.dermdex.net/). Perhaps the clinical services

> > she has provided for other companies such as Procter & Gamble, S.C.

> > and Sons, Colgate – Palmolive,

> > Schick, Neutrogena, Glaxo Pharmaceuticals, Ortho Pharmaceuticals,

> > Merck Pharmaceuticals, Allergan, Collagen Corporation, and

> > Worldwide Consumer Products, Galderma, Pharmacia and others

> > have been biased as well. If Dr. Lazoff, when she says " independent

> > studies " means a multi-center university trial, I am afraid she

>will

> > never be satisfied with Cutanix. Our R&D budget will simply not

> > afford that luxury.

> >

> > I can assure you that we are not marketing zinc oxide. Quadrinone

>has

> > been shown to inhibit the production of a number of inflammatory

> > cytokines and chemokines produced by keratinocytes, dermal

> > fibroblasts, T-Cells, and monocytes in response to inflammatory

> > inducers such as chemical irritants, ultraviolet light,

> > lipopolysacharride, and interleukin-1. Although I cannot comment

> > specifically on exactly what Quadrinone is, I can tell you the rest

> > of the ingredients that compose Dramatic Relief (I promised this in

> > my initial post). They are as they will appear on the product label:

> >

> > Water (aqua)

> > Propylene Glycol

> > Glycerin

> > Glyceryl Stearate (and) PEG 100 Stearate

> > Simmondsia Chinensis (Jojoba) Seed Oil

> > Isocetyl Stearate

> > Ethoxydiglycol

> > Paraffinum Liquidum

> > Isostearyl Palmitate

> > Niacinamide

> > Glycereth -7

> > Isocetyl Alcohol

> > PEG-7 Glyceryl Cocoate

> > Polyacrylamide (and) C13-14 Isoparaffin (and) Laureth-7

> > Quadrinone

> > Cetyl Ricinoleate

> > Phenoxyethanol (and) Methylparaben (and) Ethylparaben (and)

> > Butylparaben (and)

> > Propylparaben (and) Isobutylparaben

> > Polysorbate-20

> >

> > I'll end here by saying I'm open to further questions. Cutanix's

>goal

> > is to provide products that are effective in treating the symptoms

> > associated with many dermatologic conditions. I was convinced

>enough

> > in their mission and the results I obtained in my own lab with

>their

> > compounds that I left my tenure track assistant professor position

>at

> > a nationally renown medical school (UT Southwestern in Dallas,

>Texas)

> > to join them. As Dr. Lazoff stated, only time will tell. If the

> > lotion truly works as we have seen in our clinical studies, then

>this

> > discussion is a moot point.

> >

> > K. Pilcher, Ph.D.

> > Director of Research

> > Cutanix Corporation

>

>

>

>--

>Please read the list highlights before posting to the whole group

>(http://rosacea.ii.net/toc.html). Your post will be delayed if you don't

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>subject when replying to a digest !

>

>See http://www.drnase.com for info on his recently published book.

>

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