Re: Cutanix Study Details

[Guest guest]

,

Thank you so much for relaying information from Cutanix about their

tests. I imagine that the press release that Adam was kind enough to

point us to yesterday may have been more for investors/retail outlets

rather than the scientific community. I guess we'll have to wait

until the product is released to see if it works for a number of us.

, have you tried the product yourself?

Take care,

Matija

> I just received the following response from K. Pilcher,

> Ph.D. Director of Research at Cutanix.

>

> He says here that all the studies were double-blind placebo

> controlled, although until (or indeed if) the studies are published

> for review, we will have to take his word. Note that some of the

> text is the same as that in the document most of us will have

> already read.

>

> I also asked him if any of the studies will be published in peer-

> reviewed journals.

>

> -- begin quote

>

> We will be launching sales of this product at a National Skin Aging

> Research Conference in Chicago next week and we are very excited at

> the results we have obtained. To date, we have completed three

> clinical studies with a nationally recognized dermatologist

> investigating the effects of our product on UV-induced sunburn,

> rosacea, and eczema. All studies performed were double blinded and

> placebo controlled. For the eczema and rosacea studies 40 patients

> (20 eczema, 20 rosacea) were enrolled and treated over a 4 week

> course of Dramatic Relief lotion with 1% Quadrinone (or vehicle

> alone-placebo group). During their first visit, patients were

> evaluated by the dermatologist using 4 measurements of disease: 1)

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

> and 4) dermatitis. The dermatologist also provided an " Overall

> Severity " score, which ranged from 1-6 with 6 being the most severe

> level of overall disease. Patients were photographed to record the

> severity of the disease. After evaluation patients were sent home

> with the Dramatic Relief lotion and told to apply it morning and

> evening for two weeks. They then returned to the clinic for a two-

> week evaluation and at that time received more product for an

> additional 2 weeks. At four weeks, both the dermatologist and the

> subjects evaluated the severity of their disease. Digital

> photographs of the treated areas were also taken.

>

> Of the 20 eczema patients that started the study, 17 completed the

> four-week period. None of the subjects, including those who dropped

> out, experienced any irritation reaction or other adverse effect

> from the product. The severity of eczema decreased in 15/17

subjects

> (88%). Average improvement among those responding was 67%. This

> agrees with the anecdotal data Cutanix had acquired from volunteers

> who used the product and is a statistically significant result.

>

> Of the 20 rosacea patients that started the study, 18 completed the

> four-week period. None of the subjects, including those who dropped

> out, experienced any irritation reaction or other adverse effect

> from the product. The severity of rosacea decreased in 13/18

> subjects (72%). Average improvement among those responding was 68%.

> This agrees with the anecdotal data Cutanix had acquired from

> volunteers who used the product and is a statistically significant

> result. cea is a much more difficult disease to treat than

> eczema because of the severity of skin inflammation and

> vasodilation. We were, therefore, particularly pleased by these

> results.

>

> Considering that a 2% formulation of Quadrinone has been shown

> to be more effective in blocking UV-induced erythema than the 1%

> formulation used in this clinical study, a higher strength version

> of " Dramatic Relief " may provide even greater efficacy in treating

> rosacea. Furthermore, Cutanix scientists have now identified even

> more potent compounds related in structure to Quadrinone, and

> these may prove more effective in treating severe dermatological

> diseases.

>

> -- end quote

[Guest guest]

Hi Matija,

I think that must be the case. Dr. Pilcher (Ph.D) tells me that the

company has plans to publish in Journal of Investigative

Dermatology. They have held three poster presentations at the

Society for Investigative Dermatology Meetings (2001 and 2002).

Their priority so far has apparently been in setting up R&D

facilities, developing the product and gaining patent protection for

their technologies. As a commercial start-up, these priorities are

probably to be expected. Frustration with lack of published data is

of course frustrating for any new product and technology where the

business pressure is to make commercially available as soon as

possible.

Dr. Pilcher has been extremely prompt in responding to any of my

queries -- such correspondance must be welcomed. I am told that

Cutanix is persuing rigorous clinical studies, and I quote verbatim

here:

" Cutanix's mission is to perform rigorous cell and molecular biology

on our proprietary active molecules, formulate them in cosmetically

acceptable lotions (non-irritating and non-comedogenic), assess how

much is driven into the skin using Franz cell analysis, and perform

rigorous clinical studies to test efficacy in vivo. Our clinical

work is double-blinded and placebo controlled "

I am awaiting samples so will be sure to report to the group on my

findings.

.

> > I just received the following response from K. Pilcher,

> > Ph.D. Director of Research at Cutanix.

> >

> > He says here that all the studies were double-blind placebo

> > controlled, although until (or indeed if) the studies are

published

> > for review, we will have to take his word. Note that some of

the

> > text is the same as that in the document most of us will have

> > already read.

> >

> > I also asked him if any of the studies will be published in peer-

> > reviewed journals.

> >

[Guest guest]

This is great, . Thanks!

> Dr. Pilcher (Ph.D) tells me that the

> company has plans to publish in Journal of Investigative

> Dermatology. They have held three poster presentations at the

> Society for Investigative Dermatology Meetings (2001 and 2002).

I'm not familiar with the Journal of Investigative Dermatology, but

it's the official publication of the Society of Investigative

Dermatology, which is " an international membership of scientists,

physicians, and biomedical professionals-in-training working in

academia, industry, and government. " So it isn't a medical society

(those are the ones with the top journals), but that doesn't mean it

isn't a legitimate organization or that the journal isn't a good

second-tier publication. I just don't know.

I don't understand the phrase " plan to be published; " in a true peer-

reviewed journal, either one is awaiting to hear back after having

submitted a study for publication, or is awaiting publication of an

accepted study. Perhaps anyone who presents at their meetings has

their study published in the journal as well, if they want?

As you said, we have to see the actual published study -- but even

so, we have to remember that these are studies funded by the company

who's making the product. What we *really* want to see are

independent studies, where the study design and researchers have no

allegiance to the product and the results won't matter to anyone, one

way or the other.

In Dr. Pilcher's response to you, he said all three studies were

double-blind, placebo-controlled, but it sounded like he only

described one study to you -- the study we've already read, and

that's clearly neither blinded nor controlled.

> Their priority so far has apparently been in setting up R&D

> facilities, developing the product and gaining patent protection

for

> their technologies. As a commercial start-up, these priorities are

> probably to be expected. Frustration with lack of published data

is

> of course frustrating for any new product and technology where the

> business pressure is to make commercially available as soon as

> possible.

>

> Dr. Pilcher has been extremely prompt in responding to any of my

> queries -- such correspondance must be welcomed. I am told that

> Cutanix is persuing rigorous clinical studies, and I quote verbatim

> here:

Of course he's extremely prompt -- who signs his paycheck? It's his

job to promote his company's product, you know?

> " Cutanix's mission is to perform rigorous cell and molecular

biology

> on our proprietary active molecules, formulate them in cosmetically

> acceptable lotions (non-irritating and non-comedogenic), assess how

> much is driven into the skin using Franz cell analysis, and perform

> rigorous clinical studies to test efficacy in vivo. Our clinical

> work is double-blinded and placebo controlled "

OK, but from what we've seen so far, they are absolutely not living

up to the last part of their mission statement. (But we wouldn't

expect a company to do so -- that's the function of independent

studies.)

> I am awaiting samples so will be sure to report to the group on my

> findings.

Free samples are part of the marketing budget/promotions plans. So

even if you like the product, that doesn't mean all this isn't

marketing jazz.

By the same token, even if you don't like the product, and even if

all this is marketing jazz, even if the studies aren't well-

conducted, that still doesn't mean there isn't a good product idea

here.

Time will tell if there's really something safe and effective here or

not. For now, I'll sit on the sidelines until more thoughtful,

objective data is available, one way or the other.

Marjorie

Marjorie Lazoff, MD

> .

>

>

> > > I just received the following response from K. Pilcher,

> > > Ph.D. Director of Research at Cutanix.

> > >

> > > He says here that all the studies were double-blind placebo

> > > controlled, although until (or indeed if) the studies are

> published

> > > for review, we will have to take his word. Note that some of

> the

> > > text is the same as that in the document most of us will have

> > > already read.

> > >

> > > I also asked him if any of the studies will be published in

peer-

> > > reviewed journals.

> > >

>

[Guest guest]

Hi Marjorie,

> In Dr. Pilcher's response to you, he said all three studies were

> double-blind, placebo-controlled, but it sounded like he only

> described one study to you -- the study we've already read, and

> that's clearly neither blinded nor controlled.

I think we have to consider the context of the original document we

all read: Was it intended for the scientific community? Was it a

press release? I believe it was compiled in response to an enquiry

from a member of the public so for the moment I am tempted to give

them the benefit of the doubt and assume they have done what their

director of research says they have done.

> Of course he's extremely prompt -- who signs his paycheck? It's his

> job to promote his company's product, you know?

Personally, I welcome any company who engages with the rosacea

community, especially as we've already heard at the level of CEO in

one case and Director of Research in another. The majority of

companies would simply pass a query through to a PR department which

may or may not respond. I think the community here is right to

encourage new product developments, even without large clinical

trials to back them up.

We have seen this many times with members of this group being

involved in the development of and positively awaiting products such

as Sy's Zinco (very well received by many) and the ceacare

Strontium Products (more of a mixed review!). The word soon gets out

about people's personal experiences with these products on their

faces. As we know, Metrogel has proved itself on a number of

measurements in numerous clinical trials, many are unhappy with what

this translates to on their own faces.

I think we have to accept that large-scale clinical trials of these

products are not always possible, but that if what Cutanix is saying

is true and that these products have been in a small double-blind

placebo controlled trial, it is as good as we can expect. For the

moment, new rosacea products *will* come from smaller pharmaceutical

and cosmetic companies.

Cheers,

.

[Guest guest]

I hear you, but I still think you're being too generous, .

First, I would not compare Cutanix with either Dr. Sy or cea

Care -- I'm as convinced (as one can be) that both were and are

straightforward in their dealings with this group, but I'm not sure

we can say the same with Cutanix (maybe, but maybe not). Second, no

matter what audience it was written for, the study they described

wasn't blinded or controlled, and it used an arbitrary scoring scale.

I agree with englishtexvet -- I'm skeptical of even the best studies

sponsored by companies that create and market the product

being " tested. "

Marjorie

Marjorie Lazoff, MD

> Hi Marjorie,

>

> > In Dr. Pilcher's response to you, he said all three studies were

> > double-blind, placebo-controlled, but it sounded like he only

> > described one study to you -- the study we've already read, and

> > that's clearly neither blinded nor controlled.

>

> I think we have to consider the context of the original document we

> all read: Was it intended for the scientific community? Was it a

> press release? I believe it was compiled in response to an enquiry

> from a member of the public so for the moment I am tempted to give

> them the benefit of the doubt and assume they have done what their

> director of research says they have done.

>

> > Of course he's extremely prompt -- who signs his paycheck? It's

his

> > job to promote his company's product, you know?

>

> Personally, I welcome any company who engages with the rosacea

> community, especially as we've already heard at the level of CEO in

> one case and Director of Research in another. The majority of

> companies would simply pass a query through to a PR department

which

> may or may not respond. I think the community here is right to

> encourage new product developments, even without large clinical

> trials to back them up.

>

> We have seen this many times with members of this group being

> involved in the development of and positively awaiting products

such

> as Sy's Zinco (very well received by many) and the

ceacare

> Strontium Products (more of a mixed review!). The word soon gets

out

> about people's personal experiences with these products on their

> faces. As we know, Metrogel has proved itself on a number of

> measurements in numerous clinical trials, many are unhappy with

what

> this translates to on their own faces.

>

> I think we have to accept that large-scale clinical trials of these

> products are not always possible, but that if what Cutanix is

saying

> is true and that these products have been in a small double-blind

> placebo controlled trial, it is as good as we can expect. For the

> moment, new rosacea products *will* come from smaller

pharmaceutical

> and cosmetic companies.

>

> Cheers,

>

> .