Massive Rosacea Study (CD5024) Recruiting Underway

12 Comments ↓

#90841 RosaceaHater on February 29, 2012 at 2:20 AM

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.

#90884 David Pascoe on February 29, 2012 at 5:54 AM

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

#91706 DaveM81 on March 9, 2012 at 2:32 AM

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

#91929 RosaceaHater on March 14, 2012 at 1:58 AM

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.

#94615 RosaceaHater on April 2, 2012 at 9:31 AM

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.

#96706 RosaceaHater on April 13, 2012 at 5:49 AM

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.

#96732 David Pascoe on April 13, 2012 at 8:43 AM

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

#96756 Brady Barrows on April 13, 2012 at 12:10 PM

David,

Is this link related?

http://goo.gl/gbn8W

#96763 David Pascoe on April 13, 2012 at 1:09 PM

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.

#98445 DaveM81 on May 1, 2012 at 10:14 PM

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.

#98493 Optimistic on May 3, 2012 at 2:37 AM

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.

#98823 DaveM81 on May 4, 2012 at 5:26 PM

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