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NOW OPEN TO NON-MEMBERS. Volunteers wanted to test out a new topical compound

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  • NOW OPEN TO NON-MEMBERS. Volunteers wanted to test out a new topical compound

    -- Non-members can sign up by e-mailing: themediumdog@live.com --

    I have recently been in contact with the owner of a small company, DermaZAide, which would like to try out a compound they have patented for topical use, to see if it might help rosacea.

    The compound in question is Nafamostat mesylate/Futhan. The basis for thinking it may help rosacea is entirely theoretical: it is a broad-spectrum protease inhibitor, and specifically it has been demonstrated in vitro to inhibit the enzymes SCTE and SCCE (stratum corneum tryptic enzyme and stratum cornum chymotryptic enzyme), which have been proposed to play a central role in the pathogenesis of rosacea by Dr Richard Gallo and his team.

    The company would like volunteers to test the compound, to see whether it has any beneficial effect. (If so, a second, larger test might be conducted to generate data for a step towards proper trials).

    Specifics:

    1. It has been indicated that around 20-25 people would be needed.
    2. These people should be in the U.S. The company itself is based in the U.S., so this would make things easier practically.
    3. You must document your progress with the compound. So, a description of your condition and symptoms, maybe with photos; document your experience during use and describe results, positive and negative, maybe again with photos. A questionnaire will be sent on which to record all this.
    Also, you should use the treatment for the entire test period (a month) - unless of course there are bad side-effects. Don't worry if you can't carry on, since someone else can take your place.
    4. You must sign a waiver freeing the company from any action (see below on safety).

    A few of comments on these specifics about procedure.

    First, there is apparently the potential for more than 20-25 people to be involved, but the issue is that the company is small and the compound is expensive. If the response is overwhelming, then possibly the number should be increased. Otherwise, I will just do a random lot among the respondents. Bear in mind, we're not talking about trials lasting years – its just a month. So if results were positive, people wouldn't have to wait long to get involved in another round.

    Second, I think it would be best if those volunteering know they have tolerated at least some topicals in the past (obviously within reason. We're not the hardiest bunch!). Otherwise, if a lot of people are forced to quit after a short while, it is obviously going to diminish the use of the tests. I have no idea whether the compound is irritating.

    *

    Anyone considering volunteering should know that the compound is expected to be entirely safe, since it has been used for 20 years in Japan as a treatment for pancreatitis. If there are side-effects (beyond mere irritation), simply ceasing use and washing away should be sufficient to stop them. So you will not be putting your life (or skin) at too much risk.

    On the other hand, in terms of potential benefit, it is simply unknown, because nobody has used such a compound topically, for rosacea, for more than a week before. If you are familiar with Dr Gallo's theory (well summarized here) you will see that there is a promising theoretical case for expecting a protease inhibitor to make some impact. But the picture is still very incomplete, and has not been tested in practice.

    It does need stressing though – nobody can know what the effect will be. So you will be accepting a certain amount of risk.

    *

    The company, i.e. DermaZaide, makes a lotion which is apparently effective for rashes, itches, irritation and so on, and might aid skin repair/healing after a week or so of use. It is not indicated for rosacea, but apparently some rosaceans have reported that it helps with their redness. If you contact the company and identify yourself as a rosacea sufferer, they will send out a sample to try.

    This lotion (or gel) is what the active ingredient will be mixed in, and what you will receive.

    *

    WHAT TO DO NOW IF YOU WANT TO VOLUNTEER

    1. Send me a PM (Personal message. Click on my name 'TheMediumDog' and then on 'Send private message') indicating you want to volunteer. I'll wait for a few days and see what sort of response there is, and then depending on that, go on from there.

    2. In your PM, indicate whether you would prefer the treatment to be in a lotion-type base, or an Aloe Vera gel product. (All the participants will be using the same, in order to rule out effects of the base in the results. So one will be chosen, depending on the majority preference).

    3. I will then gather the details of the 20 volunteers and forward them to the company (so please be aware that you would be giving your personal details, i.e. name and address).

    4. They will then send out the test product, legal waiver and questionnaire, and you could get started. You would document what happened over a month of use, then send back the information. Then all of this information would be shared with the group, and we could all go from there. (Note that, in the results, nobody would appear by name. Your identity would be protected).

    (Note that you will be sent TWO products. One will contain the active ingredient, Futhan, and one will not. You would apply both, to different areas, in order to be able to distinguish the effects of the base on its own).

    *

    Oh, finally, there's no condition in terms of what your rosacea is like. Severe, mild, flushing, pustular, whatever. (Obviously, it would be best if you were pretty confident it IS rosacea). It may be that, if it worked, it would work only on a certain type; or varyingly with different types. So it would be useful to have a mixed bunch.
    Last edited by TheMediumDog; 16 July 2009, 10:55 AM.

  • #2
    The questionnaire used for getting data would obviously be important. We're the ones with the rosacea knowledge, so we know what to look for.

    So, this thread is for coming up with ideas for that questionnaire.

    Comment


    • #3
      For those who do not know about Gallo's theory, and would like to make an informed decision, here are some links to information:

      News articles (there were hundreds of articles published a couple of years ago when the results first came out. This is just one or two, randomly selected):

      From Medical News Today
      From LA Times
      A BNet article

      The best in-depth, yet layman-friendly (ish) article I have come across is this, from Dermatology focus.

      Another paper by Gallo on cathelicidins + rosacea (there are a lot) that is free to access is this one.

      There is lots on this forum about the theory. This 30-page whopper from back when the news first broke, gives some sense of things...along with the usual confusion.

      Comment


      • #4
        Thanks Alex for doing all of this work.
        This is very exciting and much appreciated.

        Comment


        • #5
          Wish I could participate but I am in Australia

          Comment


          • #6
            Aye. I'm in the UK, so same.

            If there are results, though, I'd have thought a second round could go beyond the U.S. So watch this space.

            Comment


            • #7
              OK, I think I'm going to open this up a bit. There are seven volunteers thus far. I thought the response would be bigger, but I guess it does take a degree of confidence to sign up to a trial like this.

              So, we'll say that you don't have to be a member to take part. Members have had a 5-day head-start now anyway, so that seems fair.

              I will also consult on opening to non-U.S. residents

              Comment


              • #8
                Interesting, but the way they're going about these trials is weird. My mom used to work in dermatology and what would happen is volunteers would be very carefully observed in the lab - the compounds would be measured, the researchers would make sure the volunteers were putting enough of it on, one side of the face would be treated while the other wasn't, there would be a control group, and a group that got nothing but placebo. Every single reaction was recorded by the researchers. I just don't see how people testing this medication from the comfort of their own home would be effective as far as trials are concerned.

                Comment


                • #9
                  Hi MissD,

                  Just to be clear, you are talking about proper drug trials for FDA approval, I expect.

                  This is the stage before that (actually, two stages before that). There needs to be an indication that the ingredient is worth pursuing, before you can go about setting up trials for FDA approval. And the way you go about this is these relatively more 'casual' tests.

                  As I understand it, the next stage (if there are any results) would be a lot more rigorous, and this would provide the data on the basis of which a submission would be made to the FDA.

                  This is 'cutting-edge' stuff, so there's the need to see if the theory is up to scratch.

                  Comment


                  • #10
                    Originally posted by TheMediumDog View Post
                    Hi MissD,

                    Just to be clear, you are talking about proper drug trials for FDA approval, I expect.

                    This is the stage before that (actually, two stages before that). There needs to be an indication that the ingredient is worth pursuing, before you can go about setting up trials for FDA approval. And the way you go about this is these relatively more 'casual' tests.

                    As I understand it, the next stage (if there are any results) would be a lot more rigorous, and this would provide the data on the basis of which a submission would be made to the FDA.

                    This is 'cutting-edge' stuff, so there's the need to see if the theory is up to scratch.
                    Aah, okay. That makes more sense and it's good to hear since the lead dermatologist and his studies seem legit.

                    Comment


                    • #11
                      I imagine it is t like the exploratory stage to set up hypotheses that can be scientifically proven in stages II III etc. Interested to see what happens..

                      Comment


                      • #12
                        Just to update: The final details of the participants are currently being collected in at the moment. The trial should begin in a few weeks.

                        On a slightly different note, it may be worth keeping an eye on this stage 2 clinical trial. It is the same compound they are testing out. Completion is soon - September - so hopefully results will be out after that.
                        They are not testing it on rosacea, but on Atopic dermatitis (AD) - because it is the same enzyme that is thought to be involved (kallikrein 5) in the two conditions. Partly anyway.
                        If they get negative results, though, it isn't necessarily a bad thing, since having read the patent application of the company involved, they seem to have neglected the fact that suppressing kallikrein 5 could worsen AD, because this would downregulate cathelicidin, which is thought to already be low in AD. They are focusing, rather, on the fact that supressing kallikrein 5 should improve the skin barrier, because this enzyme is involved in degrading the elements that hold the outer layer of the skin together.

                        In any case, the fact that they're doing stage 2 trials on AD (where, as said, people have a compromised barrier, and so are very prone to irritants) shows that the compound is probably pretty safe, non-irritating, and so on. Which is good to know.

                        Comment


                        • #13
                          That AD trial, above, has just been completed. So when the results come through, it will be interesting to read them. What works for eczema/AD is completely different, of course. But still...

                          Comment


                          • #14
                            looking forward to hearing how it worked!

                            Comment


                            • #15
                              Did we ever hear about the results on this compound?

                              Comment

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