Massive Rosacea Study (CD5024) Recruiting Underway

A large study looking at a treatment for the papules and pustules of rosacea is looking to recruit participants right across the US and Canada.

A web site just for this study has been created at www.pprstudy.com (Papulo – Pustular – Rosacea Study). On the site you can use your ZIP code to see if there is a study location close to you.

As there is such a good overlap with study locations this publicity push looks to be for Trial NCT01493687.

Study  NCT01493687 is for Galderma’s mysterious CD5024 1% Cream and involves 45 locations and around 1360 participants.

My guess is that CD5024 is 1% Metrocream – seems reasonable that as the trial wants to compare against the “competition” in Finacea, the concentration is 1%, it is a Phase III trial, and the target is the papules and pustules of rosacea.

[update:] CD5024 is Ivermectin

I now believe that CD5024 is not Metronidazole. I speculated last year that Galderma might be looking at at topical Ivermectin preparations – Topical Ivermectin + Metrogel from Galderma and this page from the NHS UK seems to offer a clue as well – New Drugs Online – Ivermectin.

So I will go out on a limb and say that CD5024 is Topical Ivermectin 1%. Good news – rosacea sufferers might shortly have a new treatment available to them.

Do Let Us Know

Please do let us know in the comments below if you can confirm CD5024 is Ivermectin based, or if you get to be involved in the trials, how it goes.

[update:] It has now been confirmed several times that CD5024 is indeed Ivermectin 1%.

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About the Author: David Pascoe started the Rosacea Support Group in October 1998. .

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20 Reader Comments

  1. RosaceaHater says:

    I just got screened yesterday and was accepted into the trial. It will take place in three phases over the course of a little more than a year. At first there is a 1/3 chance I might get a placebo but after 12 weeks I will get the cream for sure. My materials say there will be 681 subjects. They are taking blood samples every week for four weeks, then once a month for a year looking for changes in white blood cell counts. Will provide updates as the trial progresses.

  2. Hey thanks for letting us know. Please do indeed let us know how you get on.

  3. DaveM81 says:

    I so wish I could parttake! But as a non-US citizen, it’s not going to happen. Please, please keep us informed.

  4. RosaceaHater says:

    I just got two tubes of either medicine or placebo today. The consistency is thinner than the form my generic metro cream usually comes in. I am to apply a pea size to each of these areas: forehead, both cheeks, nose, chin; and record the time applied in the evening. I will go back to the doc in two weeks. Fingers crossed I got the real deal and it works so some of these bumps go away! I haven’t been able to use my normal medications since before I began the study two weeks ago, so I am really red and bumpy right now.

  5. RosaceaHater says:

    I am a little more than two weeks into my trial. I had a pretty good flare last week that is now calming. The flare was different than any flare I’ve ever had – it was less of the full face flushing I normally get, and more localized on each papule/pustule. The bumps went from being faintly red to almost florescent red and I got whiteheads in some areas. It was worst on the bridge of my nose and upper cheekbone area. The flared area also peeled and there was clear discharge coming from some of the more severe papules/pustules. This sounds similar to those who are self medicating with veterinary Ivermectin. The flare got so bad I considered withdrawing from the study. However, my study doc counted a huge change in the papules vs. pustules count that they tally on each visit and he also said it is common to see a change in the type of lesion before there is any improvement. So I kept with it and now the bumps are clearing up almost as abruptly as they arrived. I am fairly certain I got CD5024 and not the placebo. I will find out for sure in six weeks! If there are any questions thus far I would be happy to answer them.

    • Tracy says:

      When did your skin start to improve. I started on Monday. Today is Friday and I have lots of pustular more than I had before starting soolantra. Thank you Tracy

  6. RosaceaHater says:

    Today I had my 4 week checkup with my study doc. My papule/pustule count went from 41 my baseline visit to 29 today. The nurses commented my skin looks better. And yes, CD 5024% is ivermectin! I will have my next checkup in four weeks. At that time I will provide another P/P count and I will know if I got CD 5024 or the placebo.

  7. Excellent news, you must be feeling good about using the cream.

    Lets hope that you got the active cream and that that is the reason for your success 🙂

  8. Brady Barrows says:

    David,

    Is this link related?

    http://goo.gl/gbn8W

  9. That patent owned by Galderma talks about combining Ivermectin and Metrogel, this one looks more proscriptive.

    Topical application of ivermectin for the treatment of dermatological conditions/afflictions

    Patent number: 7550440
    Filing date: Oct 24, 2005
    Issue date: Jun 23, 2009
    Application number: 11/255,910

    Dermatological conditions/afflictions such as rosacea, common acne, seborrheic dermatitis, perioral dermatitis, acneform rashes, transient acantholytic dermatosis, and acne necrotica miliaris, most notably rosacea, are treated by topically applying onto the affected skin area of an individual in need of such treatment, a topical pharmaceutical composition which comprises a thus effective amount of ivermectin.

    Inventors: Vincent Manetta, Gary R. Watkins
    Original Assignee: Galderma S.A.
    Primary Examiner: Elli Peselev
    Attorney: Buchanan, Ingersoll & Rooney P.C.
    Current U.S. Classification: 514/30

    By my reckoning, it seems that Galderma has around 200 patents relating to rosacea. Pretty astonishing.

    davidp.

  10. DaveM81 says:

    Rosaceahater, I have no medical knowledge, but from my research and experience, the early flare up that you described sounds similar to a demodex die-off perhaps?

    Let’s hope so! Best of luck with your treatment.

  11. Optimistic says:

    I also got accepted into the trial study. Phase 1 is a 12 week trial of CD5024 1% cream versus vehicle cream (confirmed Ivermectin study). I was asked to stop Metrogel application. 1 out of 3 chance for placebo.

    Phase 2 will take the remaining 40 weeks in azelaic acid 15% gel (Finacea) study.
    If on vehicle cream for first 12 weeks (not the real thing) then azelaic acid 15% gel (Finacea) will be provided for the 40 week study, those receving CD5024 1% cream in Phase 1 will continue on CD5024 1% cream. Blood testing every two weeks for first month, thereafter every 4 weeks or upon termination/end.

    681 subjects confirmed.
    Updates as trial progresses.

  12. DaveM81 says:

    Thanks Optimistic, looking forward to hearing more. Best of luck.

  13. June Evans says:

    Can this treatment be used on people wih psoriasis, as her dermatologist has ask her to take part in a tril.but she does.nt have Rosacea. We live in the uk

  14. To be eligible for these trials you need to have papulopustular rosacea.

  15. June Evans says:

    So why has her Doctor asked her to take part in this trial

  16. Patrick says:

    I would love an update from RosaceaHater and or Optimistic.

  17. DaveM81 says:

    I would have LOVED to have got on this trial but my derm knew nothing about and was totally uncooperative (and it’s since been goodbye to him!), and my email to Galderma went unreturned.

    Would love to hear more updates too. They should be halfway or more through the trial now. The shorter ones may even have finished (I read that various different comparisons were being performed).

  18. DaveM81 says:

    The studies comparing CD5024 to metronidazole are now said to have completed. Could RosaceaHater, Optimistic and or anyone else who participated offer any further comment on this matter? This thread has been very quiet for a good while now…

  19. smgrooms says:

    I dropped out of the study after week 13. My rosacea got much worse, over 115+ pustules and numerous papules. I went had a permethrin cream treatment prescribed after a skin culture which detected no mites but I had the symptoms and the derm suspected they were dead but i was reacting badly to them. I was put back on oracea and follow the metrogel application as well. It took me approximately A year to get my skin back to normal. I have no pustules or papules any longer but have been told Ill need occasional treatments when mites come back to kill them. When they die the leave my skin with series of 50 or so pustlues on top of each other then it takes about four weeks for the mess to clear up and my body to reabsorb. I moved away from Alabama and now live in Texas. My dermatologist here is following same treatment program, have follows ups with her as often as every 6 mos. Skin cultures, yearly treatments as needed and metro grl currently. Have noticed the heat aggravates my rosacea as do acidic spicy foods and red wine.

    It appears to be an ongoing battle.

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