Last of the debate from my end

[Guest guest]

It seems as though my opening myself up to questions has only served

to foster strong, heated debate amongst me and others and yourselves.

For that I am truly sorry. This all began with an innocent e-mail

message to me that I replied to concerning details of our clinical

study. I DID NOT POST THE STUDY NOR DID I LEAK THE DOCUMENT IN THE

FIRST PLACE. I have never once suggested that our study was flawed-

as someone else has put it on the board. Furthermore, to suggest that

our science is poor without seeing all of the exhaustive in vitro

cell culture work (5 skin cell types stimulated with four separate

inflammatory inducers and investigating the expression of over 5,000

genes to find an active molecule), formulation work, delivery of

active to skin testing and finally clinical data is to make

judgements based on almost no data. I and the company stand by the

science- both the basic research that led up to the clinical study

and the clinical study itself. Those that have never met me, or

anyone associated with our company have made character judgements

that unfortunately cause me to reconsider my openness. Statements

such as

" I suspect vilification will come, though, if this investigation is

reviewed by a board of his peers. "

serve only to lower the level of debate.

As many other posters have put it here- the proof will be in the

pudding. If this were a marketing ploy by us then we were sure naïve!

For those of you who may have further questions regarding the

Dramatic Relief lotion I urge you to contact me personally via e-

mail.

I have discussed the criticisms of our clinical study at length with

our CTO, Dr. Fuller and have received his input on the results.

I am now posting those for you here. This is the last comment I will

make on our studies. If you do not wish to believe the results or

that we underhandedly skewed the data or clinician in our favor, then

there is nothing I can do to bridge that gap.

Looks like a pretty knowledgeable person looked at the data. However,

the statistics speak for themselves and that's why one does statistics

on data. A paired t test looks to see if the differences in the means

between 2 groups (baseline and 4 weeks) could have occurred by chance

or not. The answer for the control group is that this difference is

not

significant, i.e. the difference in the mean severity index between

baseline and 4 weeks could have occurred by chance. Thus the

improvement that we see in 6 patients could have happened by chance

and the only way to know for sure is to increase the number of

patients. We didn't have the money to pay for this many " vehicle "

subjects. For the Dramatic Relief lotion, the t test says the

difference between baseline and 4 weeks in severity of the disease

could not have occurred by chance and is, in fact highly significant

(0.01) which is even more significant when one considers what a small

n number we had (20 is a very small study).

We actually skewed the study against us by using our own proprietary

moisturizing lotion (containing niacinamide) that is designed to

protect the skin from lost barrier function. This lotion obviously

has some beneficial effect and in any blinded controlled study there

is always a " placebo " effect. In our case we knew going into the

study that our proprietary moisturizing formulation would help

protect the skin as would the niacinamide. We could have chosen the

safe route and used a non-prescription lotion off the shelves, but

this would not have been a true " control " . We opted to do a

rigorously controlled study and the results clearly show the anti-

inflammatory properties of Quadrinone are responsible for the

improved patient outlook. The question really is which lotion would

these rosacea sufferers prefer to use? One that gives a patient a

greater than 55% chance of showing over a 50% improvement in rosacea

with the possibility of completely getting rid of the disease

symptoms or one that has a 20% chance of showing a 50% improvement

and no chance of completely removing the symptoms of disease?

In regard to patients dropping out, there are a zillion reasons why

people drop out. In this case the patients came in and signed up and

then never came back. I don't know if Dr. Draelos called them or not

to find out why they quit. Usually it's a family or work problem.

In regard to ingredients we're very familiar with the niacinamide

data.

Both our " control " moisturizing lotion and our Dramatic Relief lotion

contain niacinamide. We engineer formulations to enhance delivery of

each ingredient we consider important, including niacinamide. Since

the control lotion contains niacinamide but no Quadrinone, it is

clear that this vitamin alone can't effectively treat rosacea and

that if you really want to alleviate the symptoms you're going to

want a product with Quadrinone, not just niacinamide.

We have patients assessments and we have erythema scoring from both

Dr.

Draelos and the patients.

There is no question that our product works at the dermal level as

well

as the epidermis. We have data on effects of quadrinone on cytokine

and

chemokine production by fibroblasts, and we even have reason to

believe

Quadrinone has anti-inflammatory effects on endothelial cells.

One note: we only used 1% Quadrinone in this product and it is

effective. We also have data that 2% is even more effective.

In short there are a lot of clinical studies we'd like to do if we had

more money. The data we have speaks for itself and shows that

significant improvement in rosacea requires Quadrinone.