Rosacea Research & Development Institute

Rosacea Research & Development Institute Newsletter - September 2005 http://www.irosacea.org The RRDi is still up and running, awaiting 501 (c) (3) approval from the Internal Revenue Service of the USA. The application was filled out and sent in by a Certified Public Accountant who did this for the unusual price of only $500. With the other expenses that leaves us about $59 in the bank. The news is that Warren Stuart, RRDi Assistant Director, has spent an untold number of hours volunteering to make a private forum for members of the corporation. This will not be a public forum and will only be available to registered corporate members of the RRDi. The RRDi has maintained a database of members but the Articles of Incorporation state that each corporate member must provide a name, a mailing address, two email addresses, and state whether or not the member is a rosacean. There are some who have joined who have not provided this information and will be notified that they are not a legal member unless they provide this information. Corporate members have certain legal voting rights in the corporation. If you wish to use the new private forum as a corporate member, you will have to REGISTER as a corporate member by going to the forum at this url > http://www.forum.irosacea.org The difference between the RRDi and all the other non profits for rosacea are: (1) First non profit organization made by rosaceans for rosaceans (2) Public access to the Articles of Incorporation, By Laws, and Conflict of Interest Policy - no other rosacea non profit to date has ever done this (3) Public access to an exact accounting of the funds received and spent - no other non profit for rosacea does this (4) Corporate members can choose who serves on the Board of Directors - no other non profit for rosacea does this. The board of directors hope you see the difference and will be a volunteer who supports the RRDi and its mission statement, as follows: The Rosacea Research & Development Institute [RRDi] is the first non-profit organization made by rosaceans for rosaceans that will collect donations for rosacea research to be performed by physicians and biomedical research scientists and includes these specific goals: Goal # 1: To be the first non profit organization for rosacea patient advocacy. Goal # 2: To have a majority of rosaceans the right to vote who sits on the board of directors. Goal # 3: To make this the first rosacea specific non profit organization to utilize most of the donations for research and treatment development. This is in stark contrast to non profit organizations that spend 50% to 80% of their donations on paying their staff. Goal # 4: To allow rosacea sufferers to guide where and how the money is spent on rosacea research and be the first non profit organization to allow rosaceans to be members of the corporation. Until June 7, 2004, the date of incorporation, there had been no other non profit organization that allowed input from rosacea sufferers. Goal # 5: To attain a level such that the RRDi can directly impact medical articles published on the subject, information disseminated to physicians and rosacea sufferers and apply positive pressure on the medical community that does not take rosacea seriously.Brady Barrows

The Zileuton Debate

A member from the RS group was saddened to read a recent release on the effect of Zileuton on moderate to severe acne in a small study. It is quite tricky to evaluate results and to extrapolate those findings to rosacea. He sadly crossed off this oral medication for rosacea too.
Some points to make that show this will be used off label for rosacea: 1. Countless rosacea sufferers using Singulair for other disorders have noticed significant clearance of inflammatory rosacea and flushing. Ths is what opened up the eyes for an even more specific medication, Zyflo (zileuton).
 2. Acne has many variables in its causation that are distinctly different from rosacea papules and pustules, so its impossible to compare.
 3. It is known and published that inflammatory leukotrienes (the ones Zyflo blocks) are involved in rosacea inflammation of the dermis, swelling, papule formation and active flushing. These are abnormally high and thus blocking the enzyme that makes them will bring relief to many. Its frustrating some times to read an article and not know how to evaluate it or come to the wrong conclusion. No problems or setbacks that I see with this med for rosacea. Even the CEO stated the promising signs of this study. "We believe this small trial supports that 5-LO inhibition may be a useful therapy in patients with moderate to severe inflammatory acne," said Critical Therapeutics President and Chief Executive Officer, Paul Rubin, M.D. "The relative severity of disease and size of the patient population in this study have given us valuable information to consider for the design of any clinical trials in acne patients that we may decide to pursue in the future."

G. Nase's View

Zileuton

Critical Therapeutics Announces Results from Phase II Study of Zileuton inAcne PatientsLEXINGTON, Mass.--

(Critical Therapeutics,Inc. (Nasdaq: CRTX ) today announced that the Company's Phase II study of ZYFLO®Filmtab® (zileuton tablets) in patients with moderate to severe inflammatoryfacial acne did not show statistical significance in its primary efficacyendpoint. The patients receiving zileuton did show positive responses totreatment and a trend toward significance in certain endpoints, however, theresponses did not achieve statistical significance (p less than or equal to0.050), as compared to the responses seen by patients receiving placebo. In thestudy, zileuton was found to be safe and well tolerated.The Phase II randomized, double-blind, placebo-controlled study involved101 patients with moderate to severe inflammatory facial acne who received afour-times-daily dosage of zileuton 600 mg (n=52) or placebo (n=49) for 12weeks. Patients were enrolled into the study at 12 sites across the UnitedStates and ranged in age from 12 to 44 years with the patient mean age being19.2 years. The study included a number of efficacy endpoints as measured by thechange from baseline to Week 12, such as the number of inflammatory lesions,which was the study's primary efficacy endpoint, the number of non-inflammatorylesions and the number of total lesions (inflammatory and non-inflammatory).The patients treated with zileuton showed a mean reduction in inflammatorylesions of 11.5, compared with a mean reduction of 9.1 lesions in the placebogroup (p=0.384). This corresponds to a mean percent decrease in inflammatorylesions of 33.5 percent in patients treated with zileuton, compared to 26.9percent in the placebo group. Patients treated with zileuton showed a meanreduction in the total number of lesions of 25.3, compared to a mean reductionof 16.4 lesions in the placebo group (p=0.085). Zileuton was well tolerated inthe study with no serious adverse events reported in patients. Moreover, therewere no zileuton-treated patients discontinued from the study due to elevationsof liver enzymes.The study also showed a positive trend toward significance in a subset ofpatients with more severe acne (baseline inflammatory lesions greater than orequal to 30). In these more severe patients, those treated with zileuton (n=26)showed a mean reduction of 16.2 inflammatory lesions, compared with a meanreduction of 11.7 inflammatory lesions in the placebo group (n=24) (p=0.063).This corresponds to a mean percent decrease in inflammatory lesions of 41.6percent in patients treated with zileuton, compared to 26.2 percent in theplacebo group (p=0.025). The study also provided data regarding the rapid effectof zileuton. Patients treated with zileuton showed marginal significance in themean reduction of total facial lesions at Week 4 (p=0.078) and Week 8 (p=0.057)."We believe this small trial supports that 5-LO inhibition may be a usefultherapy in patients with moderate to severe inflammatory acne," said CriticalTherapeutics President and Chief Executive Officer, Paul Rubin, M.D. "Therelative severity of disease and size of the patient population in this studyhave given us valuable information to consider for the design of any clinicaltrials in acne patients that we may decide to pursue in the future."The Company is continuing to analyze the data and will be working with theinvestigators to further interpret the results seen in this study. Once thisanalysis is complete, the Company will determine the appropriate next steps forthe development of zileuton in the treatment of patients with acne. The Companyexpects to provide further details about the study on its second quarterfinancial results conference call on Thursday, August 4, 2005.

Two Views of Sans Rosa - G. Nase

SansRosa is a full go. Pharmaceutical companies don't usually talk to anyone at these stages and if so, dont want to give anything out at all except to scientists or physicians, otherwise they find other companies right on their heals filing for a new drug application even though SansRosa did all the work. This is so commonplace. My discussions have been completely the opposite and I have first hand reports from actual testers (4 testers who are on this group that have contacted me). 3 of them literally said this was a life changing topical for them with regards to permanent redness, telangiectasia, and flushing was greatly reduced. The fouth one had mixed results -- some positive and some that may indicated he experienced a little bit of rebound effect. But the first pre-clinical studies were so impressive that Mayo has taken the reigns from now on -- that means a heck of a lot in itself. The first series of larger clinical studies were a complete success with all expectations being met. As any company they wilil keep on tweaking the drug throught the first II phases. Notice, it you hit the Internet, there is almost zilch on this product -- that is the way they want it because until they file a New Drug Application or Trademark down the road, it is literally free game. Plus if David was speaking to Jim Fey, I believe he has never been so overwhelmed with phone calls and is now taking a general conservative policy regarding statements -- which is actually the proper way to go for right now until they have a hold of the drug themselves. Companies swipe drugs right from underneath smaller ones too many times. As for timing, if each trial is as successful as the first two this will go very fast becase it has already been approved for human use (huge plus) and been approved for one of the hardest organs to get approved, the eyes (huge plus showing its safety), plus with superfiicial vessels in the eye there was no rebound dilation. I also have first hand experience with this substance, as does Dr. Hein, and it makes perfect sense why and how this would work. This product will not take three to four years as David speculated himself -- cut that in half. They are already recruiting for larger multicenter studies which pushed them right up on the original time frame. Its all good!
Geoffrey ----------------------
-------------------------- Dr. Geoffrey Nase

Two Views of Sansrosa - D. Pascoe

I contacted them recently because I was concerned about the hype andhope that has been pushed for sanrosa. They told me that it will beyears before they have anything interesting to say.When a product, that doesn't exist, is hyped so much, as sanrosa hasbeen, I hear warning bells.If we remember Zileuton was billed as `the biggest advance in rosaceafor 10 years'. Well recently research was published showing thatzileuton did very poorly for acne, so it is unlikely that it will getfuture work for rosacea.So lets temper how much hope we put in the next treatment around thecorner - they take a long time and setbacks are normal.

davidp.

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Rosacea Explained

Rosacea is an inflammatory skin condition that causes redness of the face. You may mistake some of its characteristics — small, red, pus-filled bumps or pustules — for acne. In fact, rosacea has been called adult acne or acne rosacea. Even though some people with rosacea had acne as teenagers, the disorder has little to do with the pimples and blackheads that commonly afflict teenagers. The cause of rosacea remains unknown.
Rosacea affects mostly adults, usually people with fair skin, between the ages of 30 and 60. About 14 million Americans have this skin condition. Although it's more common in women, men may develop more apparent signs of the disorder. It's not life-threatening, but it can affect your appearance and self-esteem.
Left untreated, rosacea tends to be progressive, which means it gets worse over time. However, in most people rosacea is cyclic, which means it may flare up for a period of weeks to months and then signs and symptoms lessen for a while before rosacea flares up again. Besides acne, rosacea can also be mistaken for other skin problems, such as skin allergy or eczema. Once diagnosed, it's quite treatable

The Signs And Symptoms of Rosacea

The signs and symptoms of rosacea include:
Red areas on your face
Small, red bumps or pustules on your nose, cheeks, forehead and chin (not the same as whiteheads or blackheads)
Red, bulbous nose (rhinophyma)
Visible small blood vessels on your nose and cheeks
Burning or gritty sensation in your eyes (ocular rosacea)
Tendency to flush or blush easily

The Phases of Rosacea

Pre-rosacea. Rosacea may begin as a simple tendency to flush or blush easily, then progress to a persistent redness in the central portion of your face, particularly your nose. This redness results from the dilation of blood vessels close to your skin's surface. This phase may sometimes be referred to as pre-rosacea.
Vascular rosacea. As signs and symptoms worsen, vascular rosacea may develop — small blood vessels on your nose and cheeks swell and become visible (telangiectasia). Your skin may become overly sensitive. Rosacea may also be accompanied by oily skin and dandruff.
Inflammatory rosacea. Small, red bumps or pustules may appear and persist, spreading across your nose, cheeks, forehead and chin. This is sometimes known as inflammatory rosacea.
In severe and rare cases, the oil glands (sebaceous glands) in your nose and sometimes your cheeks become enlarged, resulting in a buildup of tissue on and around your nose (rhinophyma). This complication is much more common in men and develops very slowly over a period of years.
In addition, more than half the people with rosacea experience ocular rosacea — a burning and gritty sensation in the eyes. Rosacea may cause the inner skin of the eyelids to become inflamed or appear scaly, a condition known as conjunctivitis.

New Rosacea Grant Pending Approval

I am pleased to announce that we are in the final stages of review and approval for an exciting grant. We can't say yet what the topic is, but we are confident that our supporters will be delighted with the grant and the new opportunities for discovery and pathways into rosacea that it will open.

We are hopeful that we can announce the title within a fortnight. The grant has already been through rigorous review, and should emerge from the final reviews and processing shortly. We expect that all of the currently available funds will go towards this grant.

I'd like to sincerely thank all of our supporters for their generosity, we can all be proud of what we have achieved.

regards,davidp.

--David Pascoe,President, Rosacea Research Foundation, http://www.rosacea-research.org/mailto:http://health.groups.yahoo.com/group/rosacea-support/post?postID=0O13LgrwH5Gw3Wmyqr28Z1rUj4V9TdSlos4XHl-T3shJ5fdJecCoJ-leXWaxYspOoaIIA_GEgRNHBaRByowgtwr9-fHOuyQb