Repost from Dr. Pilcher

[Guest guest]

I'm sure this is meant for the group:

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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