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:] I now believer that CD5024 is Ivermectin Cream 1%. See Uk Medicines Information New Drugs Online for confirmation.
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5 Comments ↓
Hi, just read this post, and could someone please tell me why they half to check the white blood count?
Thanks Maureen
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.
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.”
Thanks for that exacting reply RosaceaHater.
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