CD5024 Cream in Phase 3 Trials (Ivermectin 1%)

Written by on December 18, 2011 in Galderma, Ivermectin, Metrogel 1%, New Rosacea Treatments with 14 Comments

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Galderma has another rosacea-targeted treatment, until now undisclosed, in the final stages of approval. Hey – how come no one told me?

Could it be possible that the rosacea heavyweight Galderma has kept a new product so secret?

What is this CD5024?

Just what exactly is this CD5024 1% Cream? Galderma always give code names to their in-development products, why has no one noticed this new code so far?

I can’t find many clues, but my guess is that CD5024 is a 1% cream formulation of metronidazole.

Read on to see why my guess is that we can pretty much ignore CD5024 as being something new and innovative.

Two Clinical Trials Posted

I was first alerted to the new product CD5024 when two new clinical trials were posted at clinicaltrials.gov. Both of these are Phase 3 Trials, suggesting that the product was in the latter stages of product development.

  • Trial NCT01493947 is a Phase 3 trial comparing CD5024 to Metronidazole 0.75% for 16+36 weeks.
  • Trial NCT01493687 is a Phase 3 trial proving CD5024 works better than placebo after 12 weeks, for the papules and pustules of rosacea. A further 40 weeks to prove that CD5024 is as safe as Finacea.

So it seems a reasonable guess that as the trials want to compare against Finacea, the concentration is 1% and the target is the papules and pustules of rosacea, that CD5024 is merely metronidazole.

Another reference to CD5024 was from 2006 in an Australian trial. Perhaps this is another hint – Metronidazole in a 1% formulation is not available in Australia, so perhaps this shows that Galderma is preparing a Metrocream 1% for a wide market.

Do We Need Another Metro Sibling?

If I am correct, and CD5024 is merely MetroCream 1%, it will be joining a pretty crowded metronidazole market. Even though you can find Metrogel 1%, Metrogel 0.75%, Metrocream, Metrolotion, Noritate and even Metronidazole with sunscreen, some research suggests that it doesn’t actually matter which you choose, they all work much same. Marketing gone mad? I would suggest so.

Your Thoughts

Do you have any more information about CD5024? Please let us know in the comments below or drop me an email to david AT rosacea-support.org. Thanks.

[Update:] It has now been confirmed that Galderma’s CD5024 is Ivermectin Cream 1%.

See Uk Medicines Information New Drugs Online for confirmation of the active ingredient in CD5024.

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

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14 Reader Comments

  1. Maureen says:

    Hi, just read this post, and could someone please tell me why they half to check the white blood count?
    Thanks Maureen

    • Kali says:

      Those who are currently in a treatment program really don’t need to worry about running out. I kept all the cream I didn’t use by putting it in another vial and returning the empty tubes I was given.

      This turns out to be a waste of time because I have been out of the program for almost 2 years and my Rosacea hasn’t returned. I do get the occasional pimple, but that’s it.

      For me CD5024 is a cure. I have lots of cream left and no reason to use it.

      • Aman says:

        Hi Kali, Did this cream also helps with redness, burning, stinging of rosacea or just with pimples. Thanks.

        • Gary says:

          Yes, it did. CD5024 completely cleared up my face and forehead. I do not show any type of Rosacea now, and I haven’t used the cream in over a year. And I have 4 bottles of it left, just in case.

          • David Pascoe says:

            Hi Gary, are you sure you are talking about the not-yet-released treatment called CD5024 – the 1% Ivermectin cream ? You were part of the blinded trial for the cream?

  2. David Pascoe says:

    An increase in the white blood cell count can point to some kind of infection and a decrease can suggest some kind of immune system reduction.

    I suspect that those conducting the trial want to be sure that the topical is not responsible for either of these sorts of events.

    dp.

    • Gary says:

      Yes, I was in the clinical trial. My face looked like the poster boy for Rosacea. After about 3 weeks into the trial, there was a noticeable difference in my condition and it was completely cleared up within a couple of months. After the trial was over, I’ve had the occasional pimple, but I feel that’s normal for anyone. My condition has not returned to what it was and I consider my Rosacea either cured or in remission.

  3. RosaceaHater says:

    Hi Maureen,

    I am in the study and according to the materials they gave me, they are checking the white blood counts because:

    “In January 2009, a clinical study with CD 5024 1% cream was stopped due to the occurrence of three cases of an unexpected event in 484 subjects receiving the drug…. These events were decreases in neutrophil cell count (certain type of white blood cells) below 1.5G/L, which defines neutropenia. Neutropenia is an abnormally low level of neutrophils in the blood. Neutrophils are white blood cells produced in bond marrow which help fight against infections. Neutropenia is a serious disorder because it makes the body vulnerable to bacterial and fungal infections…. The potential relationship between neutrophenia and CD 5024 1% cannot be clearly ruled out.”

  4. David Pascoe says:

    Thanks for that exacting reply RosaceaHater.

  5. Maureen says:

    rosaceahater,
    Thanks for explaining what might happen to our white count.Very interesting. I do know how important our white count is for fighting infections.
    Thanks,
    ~maureen

  6. GW says:

    I’m currently involved in a study of CD5024, and barring any side effects, it’s fantastic! I’ve been using it for 12 weeks, and my Rosacea was pretty much gone by the 3rd week. Now I have no visible Rosacea. What am I going to do when I run out?!

    As for the white blood count, my doc knew before I did that I was sick. They called because the count was low, and that weekend I came down with a terrible cold. Thankfully, after I recovered the white count was normal.

  7. KP says:

    I am in the CD5024 study and they do draw blood at every monthly visit. I began the study in June 2012 and saw results quickly. I rarely break out and the cream has made my skin very smooth. My skin has never looked better. When the product finally comes on the market I fear I won’t be able to afford it as most new drugs are not covered by my insurance. I wonder if Galderma will have a plan to help people get the new prescription medication for a low monthly copay. That is what I did when I was on Oracea for a year. They had the dermatologist hand out an Rx card that let you pay just $25 per 30 day supply. Then I went on Medicare and was no longer eligible for the Rx card. That’s when I went looking for a clinical trial, because metro cream and gel just didn’t work for me. I hope the CD5024 study is a success and that the drug benefits many people who have rosacea. KP

  8. David Pascoe says:

    Hi KP,

    Thanks for getting back to us with your thoughts on the trial.

    Great to hear that it was working for you.

    I’m sure that many rosacea sufferers will join you in hoping that the trials continue to be successful and that Galderma gets it through to approval as quickly and as cheaply as they can.

    cheers,
    dp.

  9. JP says:

    In my opinion Rosacea and all the sub types are related to Immune system suppression. Our immune system releases a inflammatory & allergic response to the over population & decomposing Demodex mites on the face and the skin reacts abruptly to the bacteria being harbored in our pores by these little mites. It’s commons sense & it really frustrates me beyond belief. Perhaps certain environmental factors like over sun exposure contribute to the development of rosacea, simply because over sun exposure decreases our skins natural defenses, which allows Demodex populations to wreak havoc. In my opinion pimples & pus are signs of bacteria. Inflammation & swelling are the building blocks that lead up to bacterial issues. I can guarantee that every rosacea sufferer, currently dealing with a red & inflamed face will eventually develop some kind of pustule or pimple like out break. I’m NO doctor but I’m well versed in nutrition & anatomy. Many common rosacea triggers, like alcohol, sugar, fatty food, dairy products, caffeine, hot peppers sun light & stress directly effect our immune systems in some way or form. Over indulgence or overexposure to any one of these potential triggers can drastically effect our immunity over time. It amazes me how often I hear of people suffering from auto immune diseases like psoriasis or arthritis developing rosacea too. Ask yourself why?

    I believe the answer is in the name “auto immune”
    The immune system is directly being compromised & being forced to overreact or under react to it’s natural limits. People who suffer from auto immune diseases in my opinion are more likely to develop mite infestations, simply because they are already dealing with a compromised immunity. I’m beginning to belief that dermatologist are the wrong doctors for the job. Allergist/Immunologist or Medical Micro Biologist are better suited to deal with this condition. Rosacea is a mixture of three things.
    1.Suppressed Immunity
    2. Allergic reaction
    3. Parasitic infestation

    I’m truly happy that medical research is finally headed in the right direction, after 50 plus years of stupid debated theories & pointless stupid treatments. The only way to beat rosacea is to rebuild your immunity, recognize the allergic reaction & eliminate the source of infection. Elimination of demodex mites once infested may not be an easy task. I think It’s probably a chronic condition in it’s own right but the key is to treat the infestation & manage the population.

    God Bless & We will all find our peace someday soon enough!

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